Media Contact

News

The latest on how medical technology is changing lives for the better

SmartBrief
Dry eye device maker acquired by Allergan in $125M deal
Allergan has agreed to pay $125 million in cash plus undeclared commercialization milestones to purchase San Francisco-based ...Learn More
IPO brings in $180M for Natera
Natera offered 10 million shares in its initial public offering at $18 apiece and pulled in $180 million. ...Learn More
Acquisition of Zimmer Biomet assets completed by Lima
The purchase of assets from the newly formed Zimmer Biomet has been concluded by Italian orthopedic firm Lima Corporate. ...Learn More
Immucor names former Biomet exec CEO, president
Jeffrey Binder, former CEO at Biomet, was tapped to serve as CEO, president and chairman at Immucor. ...Learn More
Device could help reduce costs of orthopedic, spine implant surgeries
The Secure-Fast, a single-use ratcheting system designed for spine implant and orthopedic procedures, has been developed by ...Learn More
Next-generation spinal device from K2M debuts in U.S.
The next generation of the Mesa device, a deformity spinal technology, has been launched by K2M. ...Learn More
Kubtec's digital radiography detector cleared by FDA
The DigiView 395, a high-resolution digital radiography detector from Kubtec, has received clearance from the FDA. ...Learn More
Deadline for medtech registration filings extended in Malaysia
The deadline for submitting registrations under Malaysia's medical device fast-track program has been moved to June 30, ...Learn More
Herpes simplex virus test from Theranos cleared by FDA
A test developed by Theranos to detect herpes simplex 1 virus IgG has received 510(k) clearance from the FDA. ...Learn More
FDA labels Teleflex's resuscitator recall as Class I
A recall involving 2,405 units of Teleflex's Hudson RCI Lifesaver manual resuscitator has been categorized by the FDA as ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
The reason people find it so hard to be happy is that they always see the past better than it was, the present worse than it is, and the future less resolved than it will be.
Marcel Pagnol, novelist, playwright and ...Learn More
IPO pulls in about $66.7M for Lantheus
Lantheus Medical Imaging brought in about $66.7 million in proceeds from its now-closed initial public offering. ...Learn More
Integra spins off spine business
Integra LifeSciences has split off its spine unit SeaSpine into a standalone entity. ...Learn More
Brazilian X-ray firm purchased by Konica Minolta
Konica Minolta has agreed to pay an undisclosed amount to buy Sawae Technologica, a Brazilian maker of X-ray equipment. ...Learn More
Study shows positive results for Medtronic's varicose vein treatment device
A 12-month study found that Medtronic's VenaSeal, a device designed to treat varicose veins, recorded a closure rate of ...Learn More
Lumbar fusion device unveiled by Globus Medical
The RISE-L, a lateral lumbar interbody fusion system, has been launched by Globus Medical. ...Learn More
Chronic lymphocytic leukemia Dx test from Multiplicom debuts
The CLL Mastr Plus kit, a test designed to diagnose chronic lymphocytic leukemia, has been launched by Multiplicom. ...Learn More
FDA clears robotic catheter from Hansen Medical
The FDA has granted 510(k) clearance to Hansen Medical's Magellan 10Fr, a robotic catheter indicated for peripheral ...Learn More
Proteus Digital gains expanded approval for ingestible sensor
The sensor-enabled pill system from Redwood City, Calif.-based Proteus Digital Health has received an expanded indication ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
MedTech Compliance Boot Camp Workshop
Nov. 4-5 | Washington, D.C. ...Learn More
Happiness can be found in even the darkest of times, if only one remembers to turn on the light.
Steve Kloves, ...Learn More
IPO could pull in $135M for ConforMIS
ConforMIS has valued the 9 million shares in its initial public offering at $15 a piece in hopes of obtaining $135 million. ...Learn More
Acquisition of Zimmer Biomet assets completed by DJO Surgical
The purchase of assets from the newly formed Zimmer Biomet has been concluded by DJO Surgical, a unit of DJO Global. ...Learn More
Series C round stretched by 908 Devices to $13M
An additional $1.4 million has been raised by 908 Devices, bringing the total for its Series C funding round to $13 million. ...Learn More
German dialysis firm acquired by B. Braun unit
Avitum, the dialysis unit of B. ...Learn More
Glucose monitor from GlySure gains CE mark
European regulators have granted CE mark approval to GlySure's continuous intravascular glucose monitoring system. ...Learn More
Interbody device from Spine Wave debuts
The Leva Interbody Device, a titanium implant that allows maximum post expansion bone graft capability and ease of ...Learn More
EU OKs bladder cancer test from BioLight
Regulators in Europe have given BioLight the CE mark for its CellDetect, a test designed to detect bladder cancer. ...Learn More
FDA labels Maquet's anesthesia systems recall as Class I
A recall involving 1,641 units of Maquet Cardiovascular's Flow-i anesthesia technology has been categorized by the FDA as ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
SmartBrief will not publish Friday
In observance of Independence Day in the U.S., SmartBrief will not publish Friday. Publication will resume ...Learn More
The mystery of life is not a problem to be solved; it is a reality to be experienced.
J.J. van der Leeuw, philosopher and ...Learn More
Follow-on offering could bring in as much as $15M for EnteroMedics
St. Paul, Minn.-based EnteroMedics is looking to raise up to $15 million in a follow-on offering filed Tuesday. ...Learn More
Debt funding round pulls in up to $50M for ViewRay
A debt funding round has brought in as much as $50 million for ViewRay. ...Learn More
Financing round pulls in $12.4M for Inari Medical
A Series B funding round has brought in $12.4 million for Irvine, Calif.-based Inari Medical. ...Learn More
Aelan enters Dx partnership with Nuclea Biotechnologies
A partnership deal was reached between Aelan Cell Technologies and Nuclea Biotechnologies to create, commercialize and ...Learn More
EU OKs blood-draw device from Velano Vascular
Regulators in Europe have given Velano Vascular the CE mark for its blood-draw system as an alternative to the traditional ...Learn More
Arbor Solution's workstation connects with operating room tools, clinical stations, PACS
A medical workstation that can be connected to PACS, clinical stations and other platforms in operating rooms through ...Learn More
U.S. to release 120 medtech classes from premarket requirements
In a new final guidance document, the FDA said it would exclude 120 classes of medtech products from premarket review and ...Learn More
List of medtech standards published in Hong Kong
A list of recognized standards that in-country representatives can use to show the efficacy and safety of manufacturers' ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Love the moment and the energy of that moment will spread beyond all boundaries.
Corita Kent, nun, artist and ...Learn More
Integra to spend $312M to buy TEI Medical, TEI Biosciences
Integra LifeSciences has agreed to pay $312 million for TEI Medical and TEI Biosciences. ...Learn More
Toshiba secures strategic deal with Merge
A partnership between Toshiba America Medical Systems and Merge Healthcare will integrate Toshiba's vascular X-ray systems ...Learn More
Firms partner to develop genetic disease Dx tests
A collaboration deal to develop diagnostic tests for inherited conditions such as primary immunodeficiency disorders and ...Learn More
Balloon catheter from Bard shows positive results in study
Research in The New England Journal of Medicine showed promising results for C.R. ...Learn More
Flowonix records first patient implanted with infusion pump in Ga.
An Atlanta woman with multiple sclerosis who was experiencing severe chronic pain was the first in Georgia to be implanted ...Learn More
Fat grafting device from Acelity debuts in EU
The Revolve, a single-use fat grafting technology intended for reconstructive surgeries, has been launched by Acelity in the ...Learn More
EU Council considers changes to medical device regulations
The Council of the EU has proposed a series of amendments to the European Commission's pending Medical Device Regulation. ...Learn More
Justice Department ends probe into Abiomed's marketing of heart pump
An investigation into Abiomed's marketing of its Impella 2.5 heart pump has been concluded by the Department of Justice. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
Kindness, at least actual, is in our power, but fondness is not.
Samuel Johnson, poet and ...Learn More
IPO could bring in $75M for GC Aesthetics
GC Aesthetics, a Dublin-based maker of breast implants, intends to launch an initial public offering to raise $75 million. ...Learn More
Firms collaborate to create molecular Dx workflow joint venture
Biotype Diagnostics has struck a joint venture deal with Qiagen forming Biotype Innovation, which will create and market ...Learn More
Thyroid cancer test from Veracyte scores reimbursement win from Aetna
Aetna will make the Afirma Thyroid FNA, a test developed by Veracyte to distinguish cancerous thyroid nodules from benign ...Learn More
Former Medtronic executive joins Waters as president, CEO, board member
Christopher O'Connell has been tapped to serve as president and CEO of Waters, as well as on its board of directors, ...Learn More
Blood test proves accurate in rapid diagnosis of Ebola, study says
The accuracy of the Corgenix ReEBOV Antigen Rapid Test for Ebola was comparable to the reverse transcription polymerase ...Learn More
Lateral surgery device from Tyber Medical debuts
The Lateral Retractor System, a technology designed to help surgeons achieve successful lateral surgeries, has been launched ...Learn More
Next-generation pelvic mesh from Caldera lands FDA clearance
The FDA has granted 510(k) clearance to Caldera Medical for the next generation of its Vertessa Lite, a polypropylene mesh ...Learn More
FDA clears knee arthroplasty system from Exactech
The FDA has given Exactech clearance to market its Optetrak Logic Constrained Condylar Prosthesis, which is designed for ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
Nobody is bored when he is trying to make something that is beautiful, or to discover something that is true.
William Inge, writer and ...Learn More
IPO could pull in $108M for Glaukos
Glaukos said it will sell 6 million shares valued at $18 apiece in an initial public offering in hopes of obtaining $108 ...Learn More
LivaNova chosen as name for merged Cyberonics, Sorin
Newly merged Cyberonics and Sorin Group have rebranded as LivaNova, a name selected through employee participation and ...Learn More
Medtronic appoints new restorative therapies unit president
Geoff Martha has been named president of Medtronic's restorative therapies division. ...Learn More
FDA clears sleep apnea system from SomnoMed
The FDA has granted 510(k) clearance to Australian medtech firm SomnoMed's SomnoDent, an oral device with a micro-recording ...Learn More
Diabetes patients may benefit from V-Go insulin-delivery device
A study of 72 diabetes patients who switched to using Valeritas' V-Go insulin-delivery device showed a significant decrease ...Learn More
Cervical plate system from Nanovis debuts
The FortiBridge, a cervical plate designed for use with the FortiCore cervical interbody implant system, has been launched ...Learn More
NASA tests humanoid robot's medical capabilities on Space Station
A robot that was developed by NASA was deployed on the International Space Station to help astronauts with their medical ...Learn More
MRI-safe pacemaker from Medtronic lands FDA approval
The Advisa SR SureScan, a single-chamber pacemaker designed for use with MRI-safe SureScan leads, is being launched by ...Learn More
Balloon catheters from Spectranetics score FDA clearance
The FDA has granted 510(k) clearance to Spectranetics' 8-mm and 7-mm diameter Angiosculpt balloon catheters for percutaneous ...Learn More
SentreHeart to launch U.S. trial for Lariat device
SentreHeart has obtained approval from the FDA to conduct a trial for its Lariat device, a suture delivery technology ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
The moments of happiness we enjoy take us by surprise. It is not that we seize them, but that they seize us.
Ashley Montagu, ...Learn More
Zimmer divests assets to win U.S. antitrust approval for Biomet deal
Zimmer has received approval from antitrust regulators in the U.S. ...Learn More
Stock offering could bring in $6M for Aethlon
Aethlon Medical is hoping to secure $6 million in a stock offering of as many as 10 million shares. ...Learn More
Premier enters group purchasing agreement with Bacterin
Premier has struck an agreement giving its members special terms and pricing for Bacterin's products. ...Learn More
ISO certification granted to Protagen
Protagen has been granted ISO certification for the creation, manufacture and distribution of its in vitro diagnostic ...Learn More
Maxillofacial imaging technology for Planmed's scanner cleared by FDA
The MaxScan, a maxillofacial imaging option developed by Planmed for its Verity conebeam CT scanner, has received clearance ...Learn More
Google designs health tracker for clinical trials
The life sciences group of Google has developed an experimental device that can continuously track a patient's skin ...Learn More
Philips unveils app-connected ultrasound system
Philips Healthcare has released its Lumify transducer, which can be connected to an Android mobile device and allow it to be ...Learn More
Pa. firms support medical device tax repeal
The 2.3% medical device tax costs Pennsylvania's economy $100 million each year, according to Sen. ...Learn More
FDA clears temperature modulation device from Chicago-based firm
Chicago-based medtech firm Advanced Cooling Therapy received clearance under the FDA's de novo program to market its ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
MedTech Compliance Boot Camp Workshop
Nov. 4-5 | Washington, D.C. ...Learn More
Maybe all one can do is hope to end up with the right regrets.
Arthur Miller, ...Learn More
Biodesix stretches Series E round to $38M
A private follow-on sale with existing investors has raised an additional $11 million for Biodesix, bringing the total for ...Learn More
Fla. medtech firm gets $15M boost
A round of equity funding led by Ballast Point Ventures and River Cities Capital Funds has brought in $15 million for ...Learn More
Assets of lumbar fusion system maker acquired by Amendia
Marietta, Ga.-based Amendia has acquired SpineSelect's transforaminal lumbar interbody fusion technology assets. ...Learn More
TissueGen names senior scientist
Jennifer Seifert, who has a background in neuroscience and molecular biology, has been tapped to serve as senior scientist ...Learn More
Study begins for Biotronik's drug-eluting stent
The first patient in a clinical study of the Orsiro, a hybrid drug-eluting stent, has been enrolled by Biotronik. ...Learn More
Quidel's Group A strep test, molecular platform land FDA clearance
The FDA has given Quidel clearance to market its molecular platform, Solana, and an accompanying test. ...Learn More
Next-generation reflux management device from Torax gets FDA approval
The next generation of Torax Medical's Linx, a device developed to prevent reflux in gastroesophageal reflux disease ...Learn More
Debate on medical device tax repeal moves to Senate
The debate on whether to repeal the 2.3% medical device tax now shifts to the Senate after it was approved last week by the ...Learn More
Transcatheter aortic valve from Medtronic lands FDA approval
The CoreValve Evolut R, a transcatheter heart valve from Medtronic, has obtained premarket approval from the FDA. ...Learn More
Combo HIV test from Siemens cleared by FDA
The ADVIA Centaur HIV Ag/Ab combo test developed by Siemens has received 510(k) clearance from the FDA. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
The intellect of the wise is like glass: It admits the light of heaven and reflects it.
Augustus Hare, ...Learn More
Natera sets IPO's midpoint price at $103.3M
Natera said it intends to offer 6.25 million shares in its initial public offering in hopes of reaching a midpoint price of ...Learn More
Funding round brings in $11.5M for CyMedica
A Series A funding round led by California Technology Ventures and Research Corporation Technologies has pulled in $11.5 ...Learn More
Funding round pulls in $6.1M for mobile vision device developer
A recent funding round led by Techstars Ventures has brought in $6.1 million for Smart Vision Labs. ...Learn More
Life sciences veteran named CFO of Histogenics
Jonathan Lieber, who has over 20 years of experience in investment banking and life sciences, has been tapped to serve as ...Learn More
New patent issued to InVivo Therapeutics
InVivo Therapeutics has expanded its patent portfolio with one that covers its methods for the Neuro-Spinal Scaffold, an ...Learn More
Cardiac mapping module from Biosense Webster debuts
The Confidense cardiac mapping module, designed for use with the Carto 3 system during catheter ablation surgeries, has been ...Learn More
Tests begin for smartphone tool to help patients with chronic pain
A smartphone application has been developed by Brigham and Women's Hospital to improve the care for patients with chronic ...Learn More
EU adopts approach for regulating IVDs, medical devices
A new approach has been agreed on by the European Council concerning the regulation of medtech and in vitro diagnostic ...Learn More
EU OKs Rx pulse oximeter from Masimo
Regulators in Europe have given Masimo the CE mark for its MightySat Rx, a fingertip pulse oximeter. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
The mediator of the inexpressible is the work of art.
Johann Wolfgang von Goethe, writer and ...Learn More
Shareholders OK merger of Tornier, Wright Medical
Shareholders on Thursday approved the proposed $3.3 billion merger of orthopedic device firms Wright Medical and Tornier. ...Learn More
Maker of heart-mapping device acquired by Medtronic in $93M deal
Medtronic has purchased Cleveland-based CardioInsight Technologies and its ECVUE electrocardiographic mapping system in a ...Learn More
IPO pulls in about $47.8M for Invuity
Invuity brought in about $47.8 million in proceeds from its now-closed initial public offering that started June 15. ...Learn More
Yankee Alliance extends deal with Bacterin for biologic implants
A deal between Bacterin and Yankee Alliance, a group purchasing organization, has been extended through June 2018. ...Learn More
Hologic appoints new board chairman, lead independent director
Steve MacMillan, president and CEO of Hologic, has been tapped to succeed David LaVance as board chairman at the company. ...Learn More
Teva partners with microchip drug-delivery company
Israel's Teva Pharmaceutical Industries will pay $35 million to Massachusetts-based Microchips Biotech, which makes ...Learn More
Self-expanding stent from Terumo debuts in U.S.
The Misago, a nitinol self-expanding stent designed to address peripheral artery disease in the proximal popliteal and ...Learn More
Sorin's MRI-compatible pacemaker makes EU debut
The Kora 250 pacemaker has been released in Europe by Italian medtech firm Sorin Group. ...Learn More
EU OKs cartridge, catheter kits for ALung's respiratory-assist device
Regulators in Europe have given ALung Technologies the CE mark for its Hemolung XG4 catheter and cartridge kits. ...Learn More
FDA labels Zimmer's hip prosthesis recall as Class I
A recall involving 64 lot numbers of Zimmer's M/L Taper Hip Prosthesis with femoral stems and necks has been categorized by ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
When a thing is done, it's done. Don't look back. Look forward to your next objective.
George Marshall, military ...Learn More
Medical device tax repeal bill clears House
A measure to repeal the 2.3% medical device tax was approved by the House of Representatives in a 280-140 vote. ...Learn More
For more:
Read the AdvaMed news release for comments from President and CEO Stephen Ubl, as well as reaction from the MDMA, MITA and ...Learn More
ConforMIS sets IPO's midpoint price at $135M
ConforMIS said it intends to offer 9 million shares in its initial public offering at $14 to $16 per share, making the ...Learn More
Funding round pulls in $22M for Advanced Cell Diagnostics
A Series C equity financing round has brought in $22 million for Hayward, Calif.-based Advanced Cell Diagnostics. ...Learn More
Abiomed breaks ground on facility expansion in Mass.
Abiomed said it plans to hire 100 more workers over the next two years as it broke ground on an expansion that would add ...Learn More
FDA clears BrainPort V100 image-processing system for the blind
Middleton, Wis.-based Wicab received clearance under the FDA's de novo program to market its BrainPort V100, a technology ...Learn More
Mobile stethoscope shows promise in detecting lung diseases
A team of researchers from the Massachusetts Institute of Technology has developed a mobile stethoscope powered by a USB ...Learn More
Mobile diagnostic viewer from Agfa cleared by FDA
The FDA has granted 510(k) clearance to Agfa HealthCare's Xero, a mobile image viewer for diagnostic purposes. ...Learn More
Image-viewing software released by Calgary Scientific
The ResolutionMD 5.1, an enterprise image-viewing software intended to effectively and quickly develop treatment plans, has ...Learn More
FDA confiscates illegal drugs, devices offered online
The FDA confiscated unapproved drugs and medical devices being sold online at international mail facilities in New York, ...Learn More
Brazil lengthens technical requirement response deadline for medtech applicants
The deadline for medtech applicants to respond to technical queries about their registration filings has been formally ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
If you don't drive your business, you will be driven out of business.
B.C. Forbes, financial ...Learn More
Lantheus sets IPO's midpoint price at nearly $75M
North Billerica, Mass.-based Lantheus Medical Imaging said it intends to offer almost 7.9 million shares in a revived ...Learn More
Funding round pulls in $21M for Neuravi
A Series B financing round brought in $21 million for Galway, Ireland-based Neuravi. ...Learn More
Maker of genetics tests gets $7.5M boost
Woburn, Mass.-based Courtagen Life Sciences has obtained $7.5 million from three undisclosed backers, which is part of a ...Learn More
Transcatheter heart valve from Edwards Lifesciences gets FDA approval
The Sapien 3, a transcatheter heart valve developed by Edwards Lifesciences, has received approval from the FDA. ...Learn More
Firm develops rapid malaria Dx test
A rapid malaria diagnostic device has been developed by Disease Diagnostic Group. ...Learn More
Urinary incontinence device from Analytica cleared by FDA
The PeriCoach, a device developed by Analytica to stop or reduce urinary incontinence in women, has received 510(k) ...Learn More
Prostate/pelvic MRI coil released by ScanMed
The Procure device, an MRI coil designed to capture diagnostic images of the prostate and pelvic areas, has been launched by ...Learn More
Medical device tax repeal bill is up for vote in the House
A measure to repeal the 2.3% medical device tax was advanced Tuesday for a vote by the House Rules Committee. ...Learn More
EU OKs intraocular lens from Alcon
Regulators in Europe have given Alcon, a unit of Novartis, the CE mark for its AcrySof IQ PanOptix, an intraocular lens ...Learn More
BioLab-St. Joseph gets FDA warning over cGMP issues at Puerto Rican facility
A warning letter has been issued to BioLab-St. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Art doesn't transform. It just plain forms.
Roy Lichtenstein, ...Learn More
Welch Allyn to be acquired by Hill-Rom for $2.05B
Medical equipment maker Hill-Rom said it plans to acquire diagnostic and patient monitoring equipment maker Welch Allyn in a ...Learn More
Financing round pulls in $11.5M for CyMedica
A Series A funding round brought in $11.5 million for CyMedica Orthopedics. ...Learn More
USAID reaches $95M deal with Remote Medical for HIV test kits
The U.S. ...Learn More
PPO network operator agrees to cover PersonalizeDx's cancer tests
MultiPlan, a preferred provider network operator, has agreed to provide reimbursement coverage for PersonalizeDx's lung, ...Learn More
NuVasive names new board member
Vickie Capps, a member of the boards of Consonance Capital Partners and Enclara Pharmacia, has been tapped to serve on the ...Learn More
FDA clears ventilation system from Breathe Technologies
The FDA has granted 510(k) clearance to Breathe Technologies' Life2000, a ventilation device designed to deliver ...Learn More
Sensor for endoscopic procedures released by OmniVision
The CameraChip sensor, intended for use in endoscopic procedures, was launched by OmniVision Technologies. ...Learn More
Orthopedic system from FH Ortho cleared by FDA
The CALCAnail system, a device developed by FH Ortho for use in rear foot fusion and heel fracture procedures, has received ...Learn More
EU OKs patient monitoring platform from Masimo
European regulators have granted CE mark approval to the Root, a patient monitoring system from Masimo. ...Learn More
FDA labels Heartware's heart pump recall as Class I
A recall involving Heartware's HVAD heart pump has been categorized by the FDA as Class I. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
Rebellion without truth is like spring in a bleak, arid desert.
Kahlil Gibran, poet and ...Learn More
Glaucoma surgical device maker sets IPO's midpoint price at $75M
Laguna Hills, Calif.-based Glaukos said it intends to offer almost 5.4 million shares in its initial public offering in ...Learn More
Merck KGaA's purchase of Sigma-Aldrich cleared by EU
The $17 billion acquisition of Sigma-Aldrich by Merck KGaA was approved by the European Commission on the condition that ...Learn More
Financing round pulls in $3.1M for SpineGuard
A funding round brought in $3.1 million in equity financing for SpineGuard. ...Learn More
Crowdfunding campaign brings in about $109K for Airing
Airing has obtained roughly $109,000 through a crowdfunding campaign on Indiegogo. ...Learn More
Neurosurgery professor joins InVivo's scientific board
Dr. James Guest was tapped by InVivo Therapeutics to serve on its scientific advisory board. ...Learn More
Lung cancer companion Dx test from Ventana gets FDA approval
The FDA has granted Ventana Medical Systems, a unit of Roche, approval to market its ALK (D5F3) CDx Assay as a companion ...Learn More
Breast cancer Dx test from BioNTech debuts in EU
The MammaTyper diagnostic test for breast cancer has been released by German medtech firm BioNTech in the European market. ...Learn More
FDA clears artificial disc from Aesculap
The FDA has given Aesculap Implant Systems, a unit of B. ...Learn More
2 fertility systems from Merck approved in Europe
Regulators in Europe have given Merck KGaA the CE mark for a pair of fertility technologies. ...Learn More
FDA clears Sanovas' pulmonary Dx and treatment device
The FDA has granted 510(k) clearance to Sanovas' PulmoVia Working Channel, a single-use device intended for pulmonary ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
The old believe everything; the middle-aged suspect everything; the young know everything.
Oscar Wilde, ...Learn More
Invuity proceeds with IPO valued at $48M
Invuity's initial public offering, opening today, is priced at $12 per share, with the goal of bringing in $48 million. ...Learn More
Cyberonics, Sorin name new board members for merged entity
Rosario Bifulco, current chairman of Sorin Group, and Hugh Morrison, chairman of Cyberonics, have been tapped to serve as ...Learn More
Firm gets $1.8M deal from HHS for rapid Ebola-test development
OraSure Technologies has received a $1.8 million contract from the Department of Health and Human Services to develop a ...Learn More
Transgenomic names new board member, marketing exec
Mya Thomae, Illumina's current regulatory affairs vice president, has been tapped to serve on the board of directors at ...Learn More
Growth forecast for spinal fusion bone graft substitutes in N. America, Asia-Pacific
An analysis by Medical Market Research Reports predicts that the market for spinal fusion bone graft substitutes is poised ...Learn More
Cardiac resynchronization device from Medtronic shows positive results in study
Research in the Journal of the American College of Cardiology: Heart Failure showed promising results for Medtronic's ...Learn More
Elekta reports S. Korean installation of cranial radiosurgery device
Samsung Medical Center in Seoul, South Korea, will install Elekta's Leksell Gamma Knife Icon. ...Learn More
Cardiac ultrasound quantification solution from Philips to debut at conference
The HeartModelA.I., a cardiac ultrasound quantification technology, is being introduced by Philips Healthcare at an ...Learn More
Deep brain stimulation device from St. Jude gets FDA approval
St. ...Learn More
N.Y. medtech firm's cognition assessment tool cleared by FDA
Cerebral Assessment Systems received clearance under the FDA's de novo program to market its Cognivue, a computer-based ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Don't worry about the world coming to an end today. It's already tomorrow in Australia.
Charles M. Schulz, ...Learn More
Angioplasty balloon catheter from Medtronic debuts in U.S.
The Fortex, a balloon catheter for percutaneous transluminal angioplasty, has been launched by Medtronic. ...Learn More
Stock offering brings in around $103M for Intersect ENT
Intersect ENT pulled in aggregate proceeds of approximately $103 million in a public offering. ...Learn More
Rubifarm tapped to offer E-Qure's wound treatment device in Argentina
A deal has been struck by Argentinian medtech distributor Rubifarm to market E-Qure's bio-electrical signal treatment system ...Learn More
Installation of diabetic care system reported by CareFusion
The four hospitals of WellSpan Health, a regional health care provider in Maryland and Pennsylvania, have installed ...Learn More
Cartiva records first human implanted with hammertoe compression device
A patient at the University of Rochester Medical Center's Sawgrass Surgery Center was the first human to be implanted with ...Learn More
Hemagglutination analysis technology released by InDevR
The Cypher One technology, a software and instrument combination that automates interpretation of hemagglutination and ...Learn More
Scientists design optomechanical sensor to detect viruses, cancer tumors
Researchers from the Moscow Institute of Physics and Technology have created an ultracompact optomechanical sensor that ...Learn More
EU OKs chronic myeloid leukemia test from Asuragen
European regulators have granted CE mark approval to the Quantidex BCR-ABL IS CMR Kit from Asuragen. ...Learn More
HIV-1, HCV Dx assays from Beckman Coulter gain CE mark
European regulators have granted CE mark approval to the DxN Veris HIV-1 and DxN Veris HCV tests from Beckman Coulter. ...Learn More
List of recognized medtech standards published in Hong Kong
A list of recognized standards that medtech firms can use to show the safety and efficacy of their products has been ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
It is not enough to be industrious; so are the ants. What are you industrious about?
Henry David Thoreau, writer and ...Learn More
Gastric positioning system from Medtronic debuts in select areas
The GastriSail system, a gastric positioning device developed for bariatric surgery, has been released by Medtronic in the ...Learn More
Panasonic Healthcare Holdings to purchase Bayer's diabetes business
Bayer AG's diabetes care business unit will be acquired by Panasonic Healthcare Holdings in a deal worth about $1.1 billion. ...Learn More
Pyrobett, genome institute enter pyrosequencing Dx deal in Singapore
Singapore-based Pyrobett has struck a deal with the Genome Institute of Singapore to use pyrosequencing technology in ...Learn More
University opens medtech incubator in Mass.
The Innovation Hub, a medtech development incubator, has been launched by the University of Massachusetts at Lowell. ...Learn More
2 international managing directors named by Bioventus
Bioventus has appointed Isabelle Levy-Unger and Andrew Hosmer as international managing directors. ...Learn More
Mainstay Medical receives FDA approval for ReActiv8 clinical trial
The FDA has granted an investigational device exemption to Mainstay Medical to conduct a study assessing the efficacy and ...Learn More
FDA clears Medical Informatics' alert platform
FDA 510(k) clearance was obtained by Medical Informatics to commercially release the initial version of its patient data ...Learn More
EU OKs gamma knife device from Elekta
European regulators have granted CE mark approval to the Leksell Gamma Knife Icon from Elekta. ...Learn More
Neurostimulator device by Stimwave gets FDA IDE designation
The FDA has granted an investigational device exemption to Stimwave Technologies for a clinical study to evaluate the ...Learn More
U.S. still pressing for price transparency for medtech, drugs in TPP
U.S. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA and industry experts during this daylong virtual workshop. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Anything or anyone that does not bring you alive is too small for you.
David Whyte, ...Learn More
Calif. firm pulls in $91M from debt, equity funding
An equity and debt financing round has brought in $91 million for Outset Medical. ...Learn More
Follow-on offering could pull in $50M for TransEnterix
North Carolina-based TransEnterix hopes to sell an undisclosed amount of shares in a follow-on offering to raise $50 ...Learn More
DalCor, Roche enter deal to develop acute coronary syndrome companion Dx test
Roche has struck an agreement with DalCor Pharmaceuticals to create a companion diagnostic test that can determine which ...Learn More
QuantuMDx taps German microarray firm to commercialize nanowire technology
A partnership between German microarray company Scienion and QuantuMDx was formed to commercialize the multiplexed nanowire ...Learn More
Study assesses use of surveillance imaging in detecting lymphoma relapse
Routine follow-up positron emission tomography or computed tomography imaging was more effective in monitoring relapse among ...Learn More
Spine system from joimax debuts at conference
The iLESSYS Delta system, designed to address central spinal canal stenosis, will be introduced by endoscopic spine surgery ...Learn More
Microscope and app capture and share skin lesion images
A microscope developed for use with smartphones to capture images of moles and other skin lesions is being introduced by ...Learn More
EU OKs tibial fixation system from BIOMATLANTE
European regulators have granted CE mark approval to the OSTEOTWIN Affix Sheath, a tibial fixation technology from ...Learn More
PCR HLA test from Linkage Biosciences gains CE mark
European regulators have granted CE mark approval to the LinkSeq system, a human leukocyte antigen test from Linkage ...Learn More
Surgical sealant from Cohera wins expedited access designation from FDA
The FDA has given expedited access pathway status to Cohera Medical's Sylys, a surgical sealant designed to address ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Once we believe in ourselves, we can risk curiosity, wonder, spontaneous delight or any experience that reveals the human spirit.
e.e. cummings, poet and ...Learn More
Medtronic partners with BD Medical on insulin pump infusion set
A partnership deal to introduce an insulin pump infusion set using BD FlowSmart technology has been reached by Medtronic and ...Learn More
Follow-on offering could pull in $88M gross for Ocular Therapeutix
Ocular Therapeutix said in a regulatory filing that it will sell 4 million shares valued at $22 apiece in a follow-on ...Learn More
Funding round brings in $20M for TransMedics
A recent financing round pulled in $20 million for TransMedics. ...Learn More
Shares offering brings in $4.4 million for Ill. molecular Dx firm
A direct offering of approximately 1.2 million shares involving an undisclosed health care investor has pulled in $4.4 ...Learn More
Biodesix's lung cancer test scores reimbursement win from Aetna
Aetna has given a positive coverage decision to VeriStrat, a test for advanced non-small-cell lung cancer developed by ...Learn More
Bone fixation device from BioMedical Enterprises debuts in U.S.
The Speed Triad, a nitinol-based bone fixation technology, has been launched by BioMedical Enterprises. ...Learn More
Canada, U.S. set to release draft of aligned medtech audit program guidances
An outline of the ongoing initiatives to align the medtech regulations of Canada and the U.S. ...Learn More
Creation of medtech pricing regulator endorsed in India
The Indian government has endorsed the establishment of the National Medical Devices Authority, an autonomous body to ...Learn More
FDA labels DePuy Orthopaedics' femoral implants recall as Class II
A recall initiated by DePuy Orthopaedics involving different sizes of its LCS Complete RPS femoral implants has been labeled ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Women must try to do things as men have tried. When they fail, their failure must be but a challenge to others.
Amelia Earhart, aviator and ...Learn More
Samsung partners with Medtronic on diabetes management systems
Medtronic and Samsung Electronics have agreed to collaborate on the development of products to help manage diabetes. ...Learn More
IPO brings in $96M for EndoChoice
An initial public offering brought in $96 million for Alpharetta, Ga.-based EndoChoice. ...Learn More
Boston Scientific exec named CEO of JenaValve
Victoria Carr-Brendel, who previously served as general manager of the Bayer Interventional unit of Boston Scientific, has ...Learn More
Premaitha Health appoints finance vet as new CFO
Barry Hextall has been named chief financial officer at Premaitha Health. ...Learn More
Third patient in spinal scaffold study enrolled by InVivo
The third of five acute spinal cord injury patients has been enrolled by InVivo Therapeutics in an investigational pilot ...Learn More
2 fusion panels from ArcherDX are released
The FusionPlex solid tumor and FusionFlex lung thyroid panels have been launched by ArcherDX. ...Learn More
SPECT cameras unveiled by radiation detection tech firm
A new line of SPECT cameras known as eVance has been released by Kromek. ...Learn More
EU OKs spinal cord stimulation system from St. Jude
European regulators have granted CE mark approval to the Invisible Trial system, a neuromodulation technology from St. ...Learn More
Leukemia Dx test from QuanDx approved by EU
The Leukemia Fusion Genes Screening Kit, a qualitative molecular diagnostic test from QuanDx that uses multiplexed RT-PCR to ...Learn More
St. Jude gets FDA nod to resume aortic valve study
The FDA has given St. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
The buried talent is the sunken rock on which most lives strike and founder.
Frederick William Faber, ...Learn More
Funding round brings in $14.7M to NeuroMetrix
A recent funding round brought in $14.7 million to NeuroMetrix. ...Learn More
Financing round pulls in $4.3M for Personal Genome Diagnostics
Private financing worth $4.3 million has been obtained by Personal Genome Diagnostics. ...Learn More
Exact Sciences partners with Texas cancer center on blood tests for lung cancer
Exact Sciences agreed to collaborate with the University of Texas MD Anderson Cancer Center on the development and marketing ...Learn More
Report predicts number of FDA-cleared digital health tools to hit 100 in 2018
An Accenture study projects the number of FDA-cleared digital health devices to reach 100 in 2018, up from 33 last year, and ...Learn More
Roche's herpes simplex virus assay receives FDA clearance
The FDA has granted 510(k) clearance to Roche's cobas HSV 1 and 2 assay. ...Learn More
Spinal cord stimulation system from Boston Scientific debuts in EU
The Precision Novi device for chronic pain has been released by Boston Scientific in the European market. ...Learn More
Researchers develop blood test that reveals viral history
Researchers have produced a blood test that can detect every virus a person has ever been exposed to, according to a study ...Learn More
FDA seeks comments on modifications suggested for MedWatch forms
The FDA has proposed several modifications in the forms used for the mandatory and voluntary reporting of post-market ...Learn More
EU OKs HIV assay from Chembio Diagnostics
European regulators have granted CE mark approval to the Dual Path Platform HIV 1/2 test developed by Chembio Diagnostics. ...Learn More
Baxter's vascular patch recall labeled Class I by FDA
A recall initiated by Baxter International involving four product codes of the firm's Vascu-Guard peripheral vascular patch ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
Excellence means when a man or woman asks of himself more than others do.
Jose Ortega y Gasset, philosopher and ...Learn More
Follow-on offerings announced by 3 medtech firms
Ocular Therapeutix, Intersect ENT and Nevro have disclosed plans for follow-on offerings this week to raise additional funds ...Learn More
Report: Bone graft substitute market reached more than $850M in 2014
An iData report said the market for bone graft substitutes was worth over $850 million in 2014 and is moving toward more ...Learn More
U.S. patent for spine system issued to Intelligent Implant Systems
A U.S. patent was granted for the Revolution Spinal System developed by Intelligent Implant Systems. ...Learn More
Magellan used in first robotic radioembolization in U.S.
A patient in Miami was the first to undergo robot-assisted radioembolization surgery using Hansen Medical's Magellan robotic ...Learn More
FDA clears Cohero Health's Bluetooth-connected spirometer
Cohero Health's Bluetooth-connected spirometer received 510(k) clearance from the FDA. ...Learn More
Image-guided therapy firm to showcase brain tumor technologies
Brainlab, an image-guided therapy company, will showcase software packages for patients who have benign skull base tumors or ...Learn More
MILabs to launch latest SPECT system at SNMMI meeting
MILabs will launch G-SPECT, its new SPECT system, that offers faster brain scanning speeds at a resolution of less than 3 ...Learn More
Medtech clinical trial guidance issued in Saudi Arabia
Guidance clarifying the requirements for medtech firms conducting clinical studies in Saudi Arabia has been released by the ...Learn More
Brazil moves to strengthen anti-bribery law
Authorities in Brazil will implement additional anti-bribery provisions of the country's 2014 Clean Company Act, which ...Learn More
FDA OKs Monarch Medical's insulin dosing platform
The FDA has given Monarch Medical Technologies approval to market its EndoTool SubQ, an insulin dosing platform, in the U.S. ...Learn More
EU approves H. pylori test from Mobidiag
European regulators granted Finland's Mobidiag the CE-IVD mark for its Amplidiag H. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Once you bring life into the world, you must protect it. We must protect it by changing the world.
Elie Wiesel, writer and political ...Learn More
House committee OKs medical device tax repeal bill
A measure to repeal the 2.3% medical device tax was approved by the House Ways and Means Committee in a 25-14 vote Tuesday. ...Learn More
For more:
Read a statement from AdvaMed President and CEO Stephen Ubl commending the House on its progress toward repealing the ...Learn More
Natera aims for $100M from IPO
An initial public offering has been filed by Natera with the goal of raising as much as $100 million. ...Learn More
Joint funding round nets $26.5M for 480 Biomedical, Arsenal Medical
A joint funding round has brought in $26.5 million for sister firms 480 Biomedical and Arsenal Medical. ...Learn More
Image sharing system developer raises $17.5M
A recently closed financing round has pulled in $17.5 million for LifeImage, a cloud-based clinical image sharing system ...Learn More
Pensabio secures distribution deal with Illumina
A partnership deal was secured between Illumina and Pensabio under which Pensabio will distribute Illumina's sequencing ...Learn More
Biodesix's lung cancer test scores reimbursement win from Cigna
Cigna has given a positive coverage decision to VeriStrat, a test for advanced non-small cell lung cancer developed by ...Learn More
Chronic pain drug test released by Harmonyx
A genetic test designed to examine the efficacy and side effect risk of pain drugs was launched by Harmonyx. ...Learn More
Bruker introduces tissue typing solution
Bruker has released a tissue typing solution for use with its matrix-assisted laser desorption ionization mass spectrometry ...Learn More
Cyberonics gets FDA approval for AspireSR generator
The FDA has given Cyberonics approval to market its AspireSR generator in the U.S. ...Learn More
FDA clears ultrasound systems from Carestream Health
Carestream Health's Touch Prime and Touch Prime XE ultrasound systems have received 510(k) clearance from the FDA. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
Education is a progressive discovery of our own ignorance.
Will Durant, writer and ...Learn More
Hologic secures $2.5B credit deal
A $2.5 billion, five-year credit deal has been secured by Hologic with financiers led by Bank of America Merrill Lynch. ...Learn More
IPO could pull in as much as $60M for Calif. surgical lighting firm
Invuity said in a regulatory filing that it will sell 4 million company shares valued at $14 to $16 apiece in an initial ...Learn More
Epic Sciences announces new terms in credit facility
Epic Sciences' $5 million credit facility with Silicon Valley Bank was recently raised to $15 million. ...Learn More
Q1 revenue rises for molecular diagnostics firm
HTG Molecular Diagnostics generated $1 million in total revenue in the quarter ending March 31, an increase from $826,523 ...Learn More
Cardiologist to lead Boston Scientific's European CRM business
Dr. ...Learn More
U.S. patent issued to Zecotek for optical imaging platform
The U.S. Patent and Trademark Office has granted Zecotek Photonics a patent covering its 3D/2D optical imaging platform. ...Learn More
Cancer mutation test from Transgenomic debuts in U.S.
Transgenomic has reported the release of its Multiplexed Ice Cold PCR CLIA test for detecting mutations that indicate the ...Learn More
Medical device tax is not needed, lawmakers say
It is not uncommon for Congress to pass laws to amend sweeping reforms, but the fixes necessary to correct the Affordable ...Learn More
FDA clears Rivanna's spinal needle guidance system
The FDA has granted Rivanna Medical 510(k) clearance for its Accuro device. ...Learn More
TransEnterix submits premarket application for robotic surgical system
An application seeking 510(k) premarket approval for the SurgiBot system was submitted by TransEnterix to the FDA. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
MedTech Compliance Boot Camp Workshop
Nov. 4-5 | Washington, D.C. ...Learn More
Perfection is not attainable, but if we chase perfection, we can catch excellence.
Vince Lombardi, football ...Learn More
Corindus could bring in $41.8M in IPO
Corindus Vascular Robotics has valued the 11 million shares in its public offering at $3.80 a piece in hopes of obtaining ...Learn More
Zimmer divests assets to get FTC's support for Biomet acquisition
Zimmer has agreed to divest itself of some assets in the U.S., including the Cobalt bone cements portfolios and Zimmer ...Learn More
Funding round pulls in $3.2M for Transplant Genomics
A private stock offering involving existing and new investors has brought in $3.2 million for Transplant Genomics. ...Learn More
Report reveals fast market growth for shoulder reconstruction devices in 2014
An iData Research report found the fastest-growing sector in the orthopedic small bone and joint market last year was ...Learn More
FDA clears upgrades in Toshiba's MRI scanner
The FDA has cleared the hardware and software upgrades made by Toshiba America Medical Systems to its Vantage Titan 3T MRI ...Learn More
NeuroMetrix ships pain relief device to U.S. providers
NeuroMetrix has started shipping its FDA 510(k)-cleared Quell wearable pain relief device to providers in the U.S. ...Learn More
Life-support ventilator released by Philips in Canada
The Philips Respironics V680 Ventilator, a device designed to help patients transition to natural breathing from ...Learn More
SurgiQuest's AirSeal system gets 510(k) clearance from FDA
The FDA has granted SurgiQuest 510(k) clearance for its AirSeal device. ...Learn More
EU approves AITbiotech's dengue assay
The abTES DEN 4 qPCR I Kit, designed by AITbiotech to rapidly detect the dengue virus, got the CE-IVD mark from European ...Learn More
Japan OKs SuperSonic's ultrasound scanner
Japanese authorities approved SuperSonic Imagine to commercialize its Aixplorer ultrasound scanner in that country. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
I can't change the direction of the wind, but I can adjust my sails to always reach my destination.
Jimmy Dean, singer, actor and ...Learn More
Cardinal Health's $1.94B offer for Cordis accepted by J&J
A $1.94 billion binding offer made by Cardinal Health for Johnson & Johnson's Cordis stent-making business unit was accepted ...Learn More
Share repurchase program of up to $1.14B announced by Agilent
A plan by Agilent Technologies to buy back as much as $1.14 billion of its stock in a repurchase program was approved by the ...Learn More
Merck agrees to research collaboration deal with NanoString
NanoString Technologies is partnering with Merck to create a test that will assess the effects of Merck's anti-PD-1 therapy ...Learn More
Report: Global market for 3D printing in medical applications could hit $965M by 2019
A Transparency Market Research report predicts the value of the worldwide market for 3D printing in medical applications ...Learn More
FDA offers conditional IDE approval for Thoratec's heart pump
The FDA has granted Thoratec conditional investigational device exemption approval to study the effectiveness and safety of ...Learn More
Developing wearable tech to boost care in underdeveloped countries is goal of challenge
UNICEF is partnering with frog, a design firm, and ARM, which makes smartphone chips, on a challenge to find innovative ways ...Learn More
Swiss researchers develop blood-analysis chip
Researchers in Switzerland have produced a Bluetooth-enabled chip that can be implanted beneath the skin to analyze and ...Learn More
FDA expands clearance of Verax Biomedical's platelet test
Verax Biomedical's bacteria-detection test has been cleared by the FDA for use with two additional types of blood platelet ...Learn More
China raises registration fees amid large drug-approval backlog
The registration fees for drugs and medical devices in China will rise significantly -- to $100,637 for locally made drugs ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
The greatness of art is not to find what is common but what is unique.
Isaac Bashevis Singer, ...Learn More
Medical analytics firm bought back by founders, given new name
Mansoor Khan and Dr. Fauzia Khan have bought Alere Analytics and rebranded it Persivia. ...Learn More
Medtronic announces acquisition plan to support entry into Chinese market
Medtronic is looking to expand its sales in emerging markets, including China, and is seeking medical device developers to ...Learn More
Fast-track Diagnostics, Biocartis enter assay-development deal
A strategic partnership to design multiplex infectious disease assays has been struck by Biocartis and Fast-track ...Learn More
Ventana to design companion cancer diagnostic assay with Halozyme
Halozyme Therapeutics is partnering with Ventana Medical Systems to design and market a companion pancreatic cancer ...Learn More
Report predicts growth for spine surgery devices market in Europe through 2019
A MicroMarketMonitor report predicted the European market for spine surgery devices will hit $2.9 billion in 2019 with a ...Learn More
Boston Scientific announces effort to design leadless pacer system
A leadless pacer device that can be placed through a vein near the collarbone is being designed by Boston Scientific. ...Learn More
FDA clears 3D imaging software from EOS Imaging
An imaging solution developed by EOS Imaging for providing 3D models of the lower limb and spine has received 510(k) ...Learn More
Penumbra's aspiration thrombectomy device gets FDA OK
The FDA has granted 510(k) clearance to the Ace64 aspiration thrombectomy device from Penumbra. ...Learn More
FDA grants 510(k) clearance to InvisionHeart's ECG system
The FDA has given InvisionHeart 510(k) clearance to market its electrocardiogram mobile system in the U.S. ...Learn More
Class I recall initiated for CareFusion's ventilator
A recall initiated by CareFusion involving 15,905 Avea ventilators produced from July 1, 2011, to March 15, 2015, has been ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Bravery is being the only one who knows you're afraid.
Franklin Jones, ...Learn More
Sorin-Cyberonics merger gets shareholder approval
The merger of Sorin and Cyberonics into a new company with a $2.7 billion combined equity value has been approved by Sorin's ...Learn More
IPO could bring in as much as $28M for AirXpanders
An initial public offering on the Australian market has been filed by AirXpanders with the goal of securing as much as $28 ...Learn More
Funding round brings in $21M for SI-BONE
A capital growth funding round led by Redline Capital Management pulled in $21 million for SI-BONE. ...Learn More
Strong growth predicted for surgical robot market
An RnR Market Research report predicts the global market for surgical robots will hit $20 billion by 2021, up from $3.2 ...Learn More
NuVasive appoints new CEO
Gregory Lucier, chairman and interim CEO at NuVasive, has been named the company's CEO. ...Learn More
U.S. patent granted to SciBase's cancer detection device
A U.S. patent has been granted to SciBase for its Nevisense malignant melanoma-detection device. ...Learn More
Roche's Clostrodium difficile test receives FDA clearance
A Clostridium difficile test developed by Roche for detecting the toxin B gene in patients' stool samples has received ...Learn More
Lobo: Trade Promotion Authority bill would provide many benefits
Congress will decide this month on the Trade Promotion Authority bill, a measure that could have a great effect on the U.S. ...Learn More
FDA expands use of Ventripoint's heart analysis product
The VMS heart analysis system from Ventripoint Diagnostics can now be used in right ventricle volume and ejection fraction ...Learn More
EU approves Seegene's gastrointestinal infection test
The Allplex Gastrointestinal Full Panel Assay, designed by Seegene to test for gastrointestinal infection, has received the ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
We may encounter many defeats, but we must not be defeated.
Maya Angelou, author and ...Learn More
IPO could bring in as much as $172.5M for ConforMIS
An initial public offering has been filed by ConforMIS with the goal of securing as much as $172.5 million. ...Learn More
Financing round brings in over $25.3M for NeuWave Medical
A funding round has pulled in over $25.3 million in equity financing for NeuWave Medical. ...Learn More
Colo. firm raises $6.3M for further development of multiplex analyzer system
A recently completed Series B financing round brought in $6.3 million for MBio Diagnostics. ...Learn More
Olympus enters distribution agreement with Terumo
Olympus has struck a deal to distribute Terumo's Glidewire minimally invasive urologic product in the U.S. market. ...Learn More
Bruker's board OKs share repurchase plan
A plan by Bruker to buy back up to 1% of the company's outstanding shares in a repurchase program was approved by the ...Learn More
Analysis: Chinese orthopedics instruments market shows strong growth
A ReportBuyer analysis found that the Chinese market for orthopedic instruments had a 19.2% compound annual growth rate from ...Learn More
Breast cancer imaging system by Lumicell gets FDA IDE designation
The FDA has granted an investigational device exemption to Lumicell to conduct a pilot study to assess the feasibility of ...Learn More
Firms work on early warning system for bleeding complications
A system that can notify doctors about the bleeding events of patients during catheter-based interventions is being ...Learn More
Irish device maker joins global medical device audit initiative
Cook Medical's facility in Limerick, Ireland, completed its two-day initial certification last month to become part of the ...Learn More
MELA's imaging system pulled over gap in FDA approval
MELA Sciences has recalled 65 MelaFind systems in the U.S. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
I just invent, then wait until man comes around to needing what I've invented.
R. Buckminster Fuller, architect and ...Learn More
$50M shelf registration filed by Biocept
A shelf registration has been filed by Biocept, giving it the ability to offer $50 million in stocks or related securities. ...Learn More
OrthoSpace to use "significant" funding for orthopedic balloon system
OrthoSpace has raised an undisclosed funding amount that it called "significant" from a recent financing round participated ...Learn More
Singulex grants EMD Millipore exclusive rights to molecule counting assay
EMD Millipore has agreed to give Singulex an upfront payment, royalties and milestone payments in exchange for exclusive ...Learn More
Blog: Medtech firms should pay attention to value-based purchasing
Medtech companies must be ready to quantify the additional value their products bring to patients, compared with other ...Learn More
CMS drafts coverage of prostate cancer test from Genomic Health
A CMS contractor has released a local coverage determination draft for Genomic Health's Oncotype DX test for prostate ...Learn More
Radiation dose technology company gets U.S. patent
A U.S. patent was granted for the wireless molecular sensor system and process developed by VeriTeQ. ...Learn More
Dassault's Living Heart Project designs 3D human heart simulator
The first 3D human heart simulator will be unveiled by 3D software company Dassault Systemes on May 29. ...Learn More
FDA requests more data on Guided Therapeutics' cervical device
The FDA said it will not grant approval for Guided Therapeutics' July 2014 amendment in its premarket approval bid for the ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
SmartBrief will not publish Monday
SmartBrief will not publish Monday in observance of Memorial Day in the U.S. Publication will resume ...Learn More
Rank does not confer privilege or give power. It imposes responsibility.
Peter Drucker, management consultant and ...Learn More
Ubl: AdvaMed's Innovation Agenda would revive U.S. medtech leadership
Medical technology can save lives and reduce the burden of disease, as well as generate jobs and spur economic growth, but ...Learn More
Vermillion receives $7.5M grant for ovarian cancer test
The Cancer Prevention and Research Institute of Texas has awarded a $7.5 million grant to Austin, Texas-based diagnostics ...Learn More
San Diego-based startup raises $3M for insulin pen
A recently completed Series B financing round led by Eli Lilly & Co. brought in $3 million for Companion Medical. ...Learn More
ProTek Medical acquired by Irish medtech firm
Irish medtech company Molex has purchased ProTek Medical, a Coralville, Iowa, firm that makes vascular delivery and infusion ...Learn More
FDA grants CLIA certification to cancer Dx firm's lab
Resolution Bioscience said it has obtained CLIA certification for its laboratory. ...Learn More
Traumatic brain injury detector lands FDA clearance
BrainScope's Ahead 200 smartphone-based device has received clearance from the FDA. ...Learn More
LabCorp introduces new hepatitis C resistance tests
LabCorp has introduced two diagnostic tests for hepatitis C virus drug resistance. ...Learn More
Weight device from Emmes lands FDA clearance
A device from Emmes that can calculate the weight of a child has received clearance from the FDA. ...Learn More
Canada approves spinal cord stimulator from St. Jude
Health Canada has given St. ...Learn More
Malaysia's medical device filing deadline is June 30
Medical device companies must file with Malaysia's Medical Device Authority by June 30 to continue sales in that country, ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
He who wishes to be obeyed must know how to command.
Niccolo Machiavelli, historian and ...Learn More
Boston Scientific takes part in global diabetes initiative
Boston Scientific has joined the $9.9 million DRIVE consortium, an international program supported by the European Union's ...Learn More
Funding round pulls in $40M for Shockwave Medical
A financing round participated in by several investors including Venrock and Sofinnova Partners has brought in $40 million ...Learn More
Intraocular lens maker obtains $14.5M in financing
ClarVista Medical has raised $14.5 million in a recent funding round. ...Learn More
SonaCare Medical secures partnership deal with Invivo
SonaCare Medical, a developer of high-intensity focused ultrasound systems, has sealed a partnership deal with Invivo. ...Learn More
Medtronic reports increased Q4 sales
Medtronic posted a 59.9% increase in sales in the quarter ending April 24, bringing in $7.30 billion. ...Learn More
Hyperthermic laser system from Cynosure gets FDA clearance
A hyperthermic laser system developed by Cynosure for treating patients with noninvasive lipolysis of the flanks has ...Learn More
Visage's mobile image interpretation app obtains FDA clearance
The FDA has cleared Visage Imaging's Visage Ease Pro iOS application for mobile interpretation of diagnostic images other ...Learn More
Transcarotid stent from Silk Road Medical lands FDA approval
The Enroute device, a transcarotid stent from Silk Road Medical, has obtained premarket approval from the FDA. ...Learn More
Additional sizes of Implanet's JAZZ rods get FDA OK
The FDA recently cleared the 3.5-mm, 4-mm, 4.5-mm and 6-mm lengths of Implanet's JAZZ rods. ...Learn More
EU expands approval for Mauna Kea Technologies' endomicroscopy device
European regulators have granted Mauna Kea Technologies expanded CE mark approval for its Cellvizio confocal laser ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C. ...Learn More
All truths are easy to understand once they are discovered; the point is to discover them.
Galileo Galilei, ...Learn More
Guidance on using adaptive design in medical device studies issued by FDA
The FDA has released a draft guidance that covers how adaptive design can be properly used in the clinical studies of ...Learn More
ConvaTec seeks $1.85B to refinance debts
ConvaTec is raising a revolving credit facility of $200 million and term loan facilities worth $1.65 billion, both of which ...Learn More
Funding round brings in $8M for Abcodia
A recent financing round co-led by Scottish Equity Partners and Cambridge Innovation Capital has brought in about $8 million ...Learn More
Tokyo Future Style enters distribution agreement with KromaTiD
Tokyo Future Style has struck a deal to distribute some of the products of KromaTiD on the Japanese market. ...Learn More
OrbusNeich enrolls U.S. participants in dual therapy stent trial
The first U.S. ...Learn More
Trial shows Medtronic's pacemaker satisfies clinical performance, safety standards
Medtronic's Micra transcatheter pacing system has satisfied clinical performance and safety standards in a 140-patient ...Learn More
New urological products to be released by Olympus
Olympus reported Friday that it will release five urology products at the 2015 meeting of the American Urological ...Learn More
FDA clears bone marrow drills from Biologic Therapies
The FDA has cleared Biologic Therapies' Bio-CORE and Bio-MAC Bone Marrow Biopsy Cannula drills to be used by doctors to ...Learn More
EU approves bioresorbable stent from Arterial Remodeling
The Pure Bioresorbable Scaffold, developed by Arterial Remodeling Technologies, has obtained CE mark approval in Europe to ...Learn More
India unveils program to report, monitor medical device adverse events
The Materiovigilance Programme of India will be launched by the country's health ministry within three months to ensure that ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
There is nothing worse than a sharp image of a fuzzy concept.
Ansel Adams, ...Learn More
Nanosphere seals debt facility with NSPH Funding, raises $4.4M in financing round
A Series A financing round has brought in $4.4 million for Nanosphere. ...Learn More
Smith & Nephew buys S2 Interactive's supply chain management solutions
Smith & Nephew recently bought S2 Interactive's TrayTouch and Virtual Backtable applications. ...Learn More
Circassia to buy asthma device maker for $217M
Circassia Pharmaceuticals will pay about $217 million to purchase Aerocrine, maker of the Niox Mino, designed to detect ...Learn More
Canon U.S. Life Sciences appoints new CEO, president
Canon U.S. Life Sciences has named Akiko Tanaka its president and CEO. ...Learn More
Medtronic reports positive trial results for antibacterial device
A clinical study showed promising results for Medtonic's TYRX antibacterial envelope, which releases antimicrobial agents to ...Learn More
CVRx to launch U.S. trial for Barostim device
The FDA has given CVRx approval to conduct a pivotal trial for its Barostim device, designed for heart failure patients, in ...Learn More
Wound dressing system released by Acelity in EU
The Nanova therapy system, developed by Acelity for dressing wounds, is now available in European markets. ...Learn More
Advisory panel meets to discuss duodenoscope reprocessing concerns
The FDA's Gastroenterology-Urology Devices Panel warned that cleaning and disinfecting duodenoscopes based on reprocessing ...Learn More
Federal government develops reference material for DNA genetic testing
The U.S. ...Learn More
HeartWare's heart-assist device kit recall labeled Class I by FDA
A recall initiated by HeartWare involving its ventricular assist system pump driveline splice kit has been categorized by ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
Don't limit yourself. Many people limit themselves to what they think they can do.
Mary Kay Ash, ...Learn More
Funding round pulls in $38.9M for Intact Vascular
A Series B financing round brought in $38.9 million in venture capital for Intact Vascular. ...Learn More
Financing round boosts Neuronetics' magnetic stimulation device
A Series F funding round has pulled in $34.3 million in equity financing for Neuronetics. ...Learn More
Funding round brings in $6.6M for OncoCyte
A financing round has brought in $6.6 million for OncoCyte, including $3.3 million in cash and a $3.3 million conversion of ...Learn More
Bionic pancreas maker gains $3M from investors
Funding totaling $3 million was obtained by Bigfoot Biomedical from eight investors to support the development of its bionic ...Learn More
CMS drafts coverage of NanoString's breast cancer test
A positive local coverage determination draft was released by the CMS for the Prosigna breast cancer recurrence test ...Learn More
Q1 revenue increases for Veracyte
Veracyte generated $11.2 million in total revenue in the quarter ending March 31, up nearly 50% from $7.5 million posted in ...Learn More
Study shows positive results for Medtronic's MRI-safe ICD
A clinical study of patients with implantable cardioverter defibrillators who underwent full-body MRI scans showed positive ...Learn More
VA finds ScImage's PACS compliant with requirements
The Department of Veterans Affairs has validated the Picom365 enterprise PACS system developed by ScImage to be used at its ...Learn More
EU approves infusion catheter from Ablative Solutions
European regulators have granted Ablative Solutions CE mark approval for its Peregrine System Infusion Catheter designed to ...Learn More
Data on screening issues for higher-risk devices unveiled in Canada
New information on what reviewers commonly see when screening for deficiencies in the license applications for Class III and ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
It is not who is right, but what is right, that is of importance.
Thomas Huxley, ...Learn More
IPO could bring in as much as $86.2M for Glaukos
Laguna Hills, Calif.-based Glaukos has filed for an initial public offering with the goal of securing up to $86.2 million. ...Learn More
GE Healthcare, Abbott team up in atrial fibrillation Dx deal
A deal was reached between Abbott and GE Healthcare to combine two systems intended to map and diagnose atrial fibrillation. ...Learn More
AstraZeneca partners with Abbott to develop asthma companion Dx tests
A partnership between Abbott and AstraZeneca was formed to develop and commercialize companion diagnostic tests that can ...Learn More
Report: Market for internal trauma fixation devices in North America set for growth
A Research and Markets report predicts the North American market for internal trauma fixation devices will reach $3.8 ...Learn More
Q1 revenue increases for Invitae
Invitae generated $1.2 million in revenue in the first quarter, a nearly tenfold rise from $118,000 in the same period a ...Learn More
Cepheid Ebola test approved for WHO procurement
The Xpert Ebola assay, developed by Cepheid, was included by the World Health Organization in its list of diagnostics that ...Learn More
Spinal bracing device controller from Ellipse lands FDA clearance
The advanced external remote controller for Ellipse Technologies' MAGnetic Expansion Control Spinal Bracing and Distraction ...Learn More
Cleveland Clinic aims to boost brain health, research
The Cleveland Clinic Lou Ruvo Center for Brain Health has established the Healthy Brains Initiative, designed to promote ...Learn More
Insulin infusion device from BD Medical scores FDA clearance
BD Medical's insulin infusion set with BD FlowSmart technology has received 510(k) clearance from the FDA. ...Learn More
EU expands approval for St. Jude's cardiac technologies
St. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
No heirloom of humankind captures the past as do art and language.
Theodore Bikel, ...Learn More
Funding round brings in $38M for Autonomic Technologies
A Series D financing round led by Edmond de Rothschild Investment Partners pulled in $38 million for Autonomic Technologies. ...Learn More
Atia Medical obtains $5M for intraocular lens development
A Series B financing round brought in $5 million for Shifamed's portfolio firm Atia Medical. ...Learn More
Biodesix's lung cancer test scores reimbursement win from UnitedHealthcare
The use of Biodesix's VeriStrat, a blood-based advanced non-small cell lung cancer test, will be covered by ...Learn More
Higher test volume drives Q1 revenue growth for Biocept
Biocept generated $150,000 in revenue in the first quarter, up from $28,000 in the same period a year earlier. ...Learn More
Q1 revenue increases for Calif. molecular Dx firm
CareDx reported a 22% year-over-year revenue increase in the quarter ending March 31. ...Learn More
Lithoplasty catheter from Shockwave Medical shows positive results in trial
A six-month study involving 35 patients who have peripheral artery disease showed promising results for Shockwave Medical's ...Learn More
Use of "liquid biopsies" is becoming more common
Physicians increasingly are employing noninvasive blood tests to identify cancers, guide treatment and monitor responses to ...Learn More
EU, U.S. approve cryoablation device from Medtronic
The Arctic Front Advance ST Cryoablation Catheter, developed by Medtronic, has obtained CE mark approval in Europe to treat ...Learn More
FDA clears new features added to Toshiba's CT systems
The FDA has cleared the software and detector upgrades made by Toshiba America Medical Systems to its Aquilion One CT ...Learn More
Boston Scientific reaches settlement deal in transvaginal mesh case
Boston Scientific agreed to settle with a patient in a case being heard in the U.S. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
The great aim of education is not knowledge but action.
Herbert Spencer, philosopher and ...Learn More
Suture device maker obtains $35M loan
CRG has granted Ceterix Orthopaedics a term loan worth $35 million. ...Learn More
Funding round brings in $8.5M for Cartiva
An oversubscribed Series D financing round led by New Enterprise Associates and supported by new investor Windham Venture ...Learn More
Q1 revenue rises for bioanalytical solutions company
Vermillion generated $951,000 in total revenue in the quarter ending March 31, up from $305,000 posted in the same period ...Learn More
Nanosphere revenue rises in Q1
Nanosphere generated $4.6 million in revenue in the quarter ending March 31, an increase of nearly 40% from $3.3 million ...Learn More
Industry veteran named VP of business development at Bioventus
Thomas Umbel, who has over 30 years of medical diagnostic and device industry executive management experience, was tapped to ...Learn More
2 trial participants implanted with ImThera sleep apnea device
ImThera Medical reported that its aura6000 sleep apnea system has been implanted in its first two U.S. ...Learn More
6 groups win digital health challenge
The Office of the National Coordinator for Health IT has announced the six winners of its Market R&D Pilot Challenge. ...Learn More
Lawmakers ask for vote on medical device tax repeal before Memorial Day
Rep. ...Learn More
FDA OKs Roche's mutation test for colorectal cancer
The FDA approved the cobas KRAS Mutation Test developed by Roche Holding for use in metastatic colorectal cancer patients ...Learn More
Wireless bladder implant by StimGuard gets investigational device exemption
The FDA has granted an investigational device exemption to StimGuard to conduct a clinical study for its overactive bladder ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
Sadly, it's much easier to create a desert than a forest.
James Lovelock, ...Learn More
Yared: Device tax repeal would provide more capital for innovation
Not only does the 2.3% medical device tax stifle growth and threaten jobs, but it has also had an impact on the amount of ...Learn More
Tornier, Wright Medical shareholders to vote on merger
A set of meetings has been scheduled by Tornier and Wright Medical on June 18 for shareholders to vote on whether to approve ...Learn More
Boston Scientific floats $1.85B debt-for-acquisition deal
Boston Scientific is offering senior notes totaling $1.85 billion to fund the company's purchase of the American Medical ...Learn More
Lucigen enters distribution partnership with Sigma-Aldrich unit in India
Sigma-Aldrich's unit in India has struck a deal to exclusively distribute the life science reagents of Lucigen in the Indian ...Learn More
Dehaier signs supply deal with Sonqao Health Checkup Institution
A contract has been signed by Dehaier Medical to supply Chinese physical examination company Sonqao Health Checkup ...Learn More
Roka Bioscience reports revenue growth in Q1
Roka Bioscience generated $1.5 million in revenue in the quarter ending March 31, up 81% from $828,000 posted in the same ...Learn More
Epigenomics: Most patients take blood-based colon cancer test
Epigenomics, a diagnostics firm in Germany, reported that 99.5% of pivotal trial participants complied with the company's ...Learn More
Pneumonia-detecting app tested in Africa
A low-cost mobile health application is being tested by health care workers to diagnose pneumonia in African children. ...Learn More
Medicrea unveils second-generation spinal fixation connector
The LigaPASS 2.0 band, a spinal fixation connector device, was released by The Medicrea Group on the U.S. market. ...Learn More
Nevro lands FDA approval for Senza spinal cord stimulation system
The Senza system, Nevro's device that relieves trunk or limb pain without paresthesia by sending electrical pulses to the ...Learn More
Surefire's infusion system gains CE mark
European regulators have granted Surefire Medical CE mark approval for its Precision system, a device that delivers drugs to ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
MedTech Compliance Boot Camp Workshop
Nov. 4-5 | Washington, D.C. ...Learn More
I stole everything I ever heard, but mostly I stole from the horns.
Ella Fitzgerald, jazz ...Learn More
Welch Allyn seals acquisition deal with Scale-Tronix
Welch Allyn, which specializes in developing diagnostic tools, has agreed to pay an undisclosed sum to buy Scale-Tronix, a ...Learn More
Funding round nets $195M for Adaptive Biotechnologies
A Series F funding round has pulled in $195 million for Adaptive Biotechnologies. ...Learn More
Moximed gets $33M from investors to support knee implant
Hayward, Calif.-based Moximed has obtained $33 million in private equity financing from four returning investors and new ...Learn More
CombiMatrix posts revenue growth in Q1
CombiMatrix generated $2.3 million in revenue in the quarter ending March 31, up 28% from $1.8 million posted in the same ...Learn More
Fluidigm's revenue rises in Q1
Fluidigm posted earnings of $26.7 million in the first quarter, a 4% increase over the same period last year. ...Learn More
Direct Flow Medical names new CEO, CFO
Daniel Lemaitre, former CoreValve CEO, was tapped to succeed Bernard Lyons as CEO and president of Direct Flow Medical. ...Learn More
Positive results achieved for Intact Vascular's PAD device
A first-in-human trial of Intact Vascular's Tack system showed positive results, according to a study published in the ...Learn More
New iPhone device may help doctors treat parasitic disease
Doctors working to treat people infected with the parasitic worm Loa loa can now use a new handheld device that turns the ...Learn More
Medtronic to evaluate in-office approach to implanting heart monitor
A clinical study will be conducted by Medtronic to compare the effectiveness of in-office insertion of Reveal Linq, an ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. ...Learn More
In any project, the important factor is your belief. Without belief, there can be no successful outcome.
William James, philosopher and ...Learn More
IPO could pull in as much as $115M for EndoChoice
An initial public offering has been filed by EndoChoice with the goal of securing as much as $115 million. ...Learn More
Molecular Dx firm looks to raise $44.4M from IPO
HTG Molecular is selling 3.57 million shares in an initial public offering with the goal of securing net proceeds of about ...Learn More
Analysis: Market for internal trauma fixation devices in Asia-Pacific set for growth
A ReportBuyer analysis predicts the Asia-Pacific market for internal trauma fixation devices will see a 6.7% compound annual ...Learn More
Q1 revenue increases for Sequenom
Sequenom generated revenue of $37.8 million during the first quarter, a 2% increase from the $37.1 million in revenue posted ...Learn More
Instruments, consumables drive Q1 revenue growth for NanoString
NanoString Technologies posted $11.6 million in revenue in the quarter ending March 31, a 32% increase from the $8.8 million ...Learn More
Transcend Medical reports positive trial results for glaucoma stent
A two-year study involving over 500 patients who have mild to moderate glaucoma showed promising results for Transcend ...Learn More
Watson gets the job at 14 cancer centers that aim to personalize treatment
Fourteen cancer centers in the U.S. ...Learn More
Older guidance documents withdrawn by FDA
Forty-seven draft guidance documents covering various areas including drugs, diagnostics and medtech products that were ...Learn More
Lawmaker: Bill to repeal medical device tax could be passed soon
A measure to repeal the 2.3% excise tax on medical devices will be passed sometime this year, Rep. ...Learn More
Smith & Nephew gets FDA warning over quality issues at Mass. facility
A warning letter has been issued to Smith & Nephew by the FDA over quality-control problems affecting mechanical ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
Great spirits have always encountered violent opposition from mediocre minds.
Albert Einstein, theoretical ...Learn More
Debt financing round pulls in $17M for Labcyte
Silicon Valley Bank and Oxford Finance granted Sunnyvale, Calif.-based Labcyte a credit facility worth $17 million. ...Learn More
Deal to acquire Spinal Modulation completed by St. Jude
The acquisition of Spinal Modulation by St. Jude Medical has been completed. St. ...Learn More
Oncotype DX tests drive Q1 revenue growth for Genomic Health
Genomic Health generated $68.2 million in revenue in the quarter ending March 31, an increase from the $67 million in ...Learn More
Q4 profit increases for Abiomed
Abiomed generated $98.9 million in profits on $67.6 million in sales in the quarter ending March 31. ...Learn More
Japanese firm unveils blood-pressure monitoring system
The HEM-9200T system, a blood-pressure monitor that allows chronically ill patients to track their health from home, was ...Learn More
Inmar unveils digital health competition with Flywheel
A health application development competition has been unveiled by Inmar, a retail technology company, working in partnership ...Learn More
Ubl: Device tax is paid at the cost of life-changing innovation
Depressed job growth and decreased innovation are the true outcomes of the medical device tax, writes AdvaMed President and ...Learn More
FDA to lower risk classification of some medical devices
The FDA's Center for Devices and Radiological Health said it will place a larger emphasis on postmarket information in ...Learn More
Balloon catheter from Medtronic scores FDA clearance
The Euphora, a semicompliant balloon dilation catheter from Medtronic, has received 510(k) clearance from the FDA. ...Learn More
FDA clears cervical plate system from Medtronic
The Zevo, an anterior cervical plate device from Medtronic, has received 510(k) clearance from the FDA. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
IDE Submissions Workshop
Oct. ...Learn More
Hope is like the sun, which, as we journey toward it, casts the shadow of our burdens behind us.
Samuel Smiles, ...Learn More
Development-stage medtech firm targets $23M from IPO
Pavmed, a development-stage medtech company, has filed for an initial public offering with the goal of securing $23 million. ...Learn More
Neuromodulation technology startup gets $17.3M in equity financing
Axonics Modulation Technologies, a startup developing neuromodulation devices for various medical conditions, has secured ...Learn More
Assay sales drive Q1 revenue growth for Luminex
Luminex generated $57.7 million in revenue in the quarter ending March 31, up 2% from the $56.6 million generated in the ...Learn More
Q1 revenue increases for Exact Sciences
Exact Sciences posted revenue of $4.3 million during the first quarter, an increase from the $294,000 in revenue reported ...Learn More
EU approves cardiac monitoring device from Biotronik
European regulators have granted Biotronik CE mark approval for its CardioMessenger Smart system, a device that ...Learn More
Spine alignment technology from NuVasive debuts in U.S.
The Integrated Global Alignment system, a platform developed by NuVasive for spinal column alignment, is being launched this ...Learn More
Extracranial pressure device from Invictus cleared by FDA
The GELShield, a device developed by Invictus Medical to relieve extracranial pressure in newborns, received clearance from ...Learn More
FDA website gives public access to information on devices with unique identifiers
The FDA has unveiled a website on which the public can find information submitted by firms for medtech products with unique ...Learn More
Medtronic gains expanded approval for surgical navigation tool
Medtronic's StealthStation surgical navigation device has been given an expanded indication by the FDA to include pediatric ...Learn More
Spine device from LinkSPINE gets FDA clearance
The FacetLINK, a device developed by LinkSPINE to stabilize the spine after microsurgical or midline decompression, has ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
510(k) Submissions Workshop
Oct. ...Learn More
If we do not plant knowledge when young, it will give us no shade when we are old.
Lord Chesterfield, ...Learn More
Funding round pulls in $24M for maker of prostate cancer ablation device
A private placement led by Cormark Securities and GMP Securities brought in $24 million for Profound Medical. ...Learn More
BioFire enters distribution partnership with LABSCO
LABSCO has struck a deal to exclusively distribute BioFire Diagnostics' FilmArray technology in some U.S. markets. ...Learn More
Spinout of spinal cord stimulation unit considered by Greatbatch
Spinal cord stimulation unit Algostim would become a publicly traded company under a plan being considered by Frisco, ...Learn More
EU orthopedic trauma device market being hurt by public tendering
An iData Research report found that the continued increase in public tendering in most European countries is causing a ...Learn More
Ortho Clinical names new board members
Thomas MacMahon, former chairman and CEO of Laboratory Corp. ...Learn More
ConvaTec promotes interim CEO to post
ConvaTec has appointed Paul Moraviec its CEO. ...Learn More
Agency awards nearly $810,000 to Canadian imaging firm
The Federal Economic Development Agency for Southern Ontario has awarded repayable funding of close to $810,000 to Exact ...Learn More
Nuclear medicine imaging market for SPECT, PET poised for growth, report says
An RnR Market Research report predicts the global nuclear medicine imaging market for SPECT and PET devices will hit $2.2 ...Learn More
EU competent authorities made fewer medtech reports in Q1
The medtech product reports exchanged between competent authorities in the European Union dropped 14% in the first quarter, ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
eMDR Compliance Countdown: Preparing for the Deadline webinar
June 25 | 1-2 p.m. EST Aug. ...Learn More
Life shrinks or expands according to one's courage.
Anais Nin, ...Learn More
Spinal Modulation to be acquired by St. Jude for $175M
St. ...Learn More
Novation enters distribution deal with Vascular Pathways
Novation has struck a deal to distribute Vascular Pathways' AccuCath, a line of intravascular catheters. ...Learn More
Misonix signs supply deal with third-party provider
MedAssets, a third-party supply chain management and procurement services provider, has signed a U.S. ...Learn More
Report: 4 firms accounted for 70% of orthopedic device market revenue in 2014
A Kalorama Information report identified Medtronic, Zimmer, Stryker and DePuy Synthes as the biggest makers of orthopedic ...Learn More
Stent graft from Medtronic shows positive results in study
The Endurant AAA, a stent graft system from Medtronic, demonstrated strong results in patients with abdominal aortic ...Learn More
Trial underway for Medtronic's renal denervation-cardiac ablation combo therapy
A 245-patient, multisite feasibility trial has been launched by Medtronic to assess the use of its Symplicity Spyral renal ...Learn More
U.S. patent issued to Sensory NeuroStimulation's restless legs syndrome device
The U.S. ...Learn More
FDA approves pregnancy blood test from Abbott
The FDA has granted Abbott approval for its i-STAT Total -hCG, a blood test that can determine the pregnancy status of ...Learn More
Spinal cord stimulation device from St. Jude gets FDA clearance
The Protege MRI system, an implantable spinal cord stimulation device from St. ...Learn More
EU approves coronary stent from Stentys
European regulators have granted Stentys CE mark approval for its Xposition S system, a sirolimus-eluting, self-apposing ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
A quarrel between friends, when made up, adds a new tie to friendship.
Francis de Sales, ...Learn More
Lawmakers move on 21st Century Cures bill
A revised draft of the 21st Century Cures bill was released by the Senate Energy and Commerce Committee's leaders on ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the revised discussion draft of the 21st Century Cures ...Learn More
Stock offering could bring in $30M for Alliqua
Alliqua Biomedical is hoping to secure $30 million in a public offering of almost 6.9 million shares. ...Learn More
Debt financing pulls in $26M for Lombard
A loan from Oxford Finance worth $26 million has been secured by Lombard Medical Technologies. ...Learn More
OpGen looks to raise $18.7M from IPO
OpGen, a molecular diagnostics firm based in Maryland, has filed plans to sell 2.5 million shares in an initial public ...Learn More
Molecular Dx segment drives Q2 revenue growth for Hologic
Hologic generated $655.5 million in revenue in the quarter ending March 28, compared with $625 million in the same period a ...Learn More
Brainlab, Boston Scientific partner on distribution deal
Boston Scientific and Brainlab have partnered on a distribution deal that will package the Vercise deep brain stimulation ...Learn More
Quadriceps muscle atrophy device from CyMedica debuts in U.S.
The CyMedica QB1 System, a post-operative knee brace and wrap designed to address quadriceps muscle atrophy, was launched in ...Learn More
Reintroduced bill to ease regulatory oversight of HIT tools
The Medical Electronic Data Technology Enhancement for Consumers' Health Act has been reintroduced in the Senate by Sens. ...Learn More
Timeline for FDA approval of bone graft pushed back by Wright Medical
Wright Medical has moved the timeline for the expected regulatory approval of its Augment bone graft from May to the second ...Learn More
Boston Scientific to pay nearly $119M to resolve transvaginal mesh cases
Boston Scientific agreed to pay about $119 million to settle 2,970 cases claiming that the firm's transvaginal mesh for ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A quarrel between friends, when made up, adds a new tie to friendship.
Francis de Sales, ...Learn More
Intarcia gets $225M boost
An additional $225 million was raised by Intarcia Therapeutics in a debt funding round, bringing its total for the round to ...Learn More
Funding round pulls in $35M for Scanadu
A Series B financing round led by Fosun International brought in $35 million for Scanadu, a Mountain View, Calif., firm that ...Learn More
Bacterin's dermal allograft scores reimbursement win from Medicare contractor
Novitas Solutions, a Medicare Administrative Contractor, announced that it will cover the use of bioengineered skin ...Learn More
Q1 revenue rises for Fla. cancer genetics testing firm
NeoGenomics generated $23 million in revenue in the quarter ending March 31, up from $18.2 million during the same period ...Learn More
Drug-eluting stent from Boston Scientific shows positive results in trial
A 57-patient study showed promising results for Boston Scientific's Eluvia, a drug-eluting stent for treating peripheral ...Learn More
Study: Genetic tests help guide care for critically ill infants
Rapid genetic tests can give physicians diagnoses that help them make treatment decisions for critically ill infants and in ...Learn More
Volpara adds features to breast density solution
Upgraded VolparaDensity software has been released by Volpara Solutions. ...Learn More
Electroceuticals disrupt neuroscience
Small devices that modulate neural signals promise to upend neurologic medicine, panelists at the World Medical Innovation ...Learn More
Canada approves endoscopes from Strauss Surgical
Health Canada has given Florida-based Strauss Surgical approval to market its Optiks HD laser-welded endoscopes. ...Learn More
CryoLife resolves issues at Ga. facility
The FDA has issued a closeout letter clearing CryoLife's Kennesaw, Ga., facility after the agency found that CryoLife had ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Courage is fire, and bullying is smoke.
Benjamin Disraeli, prime minister and ...Learn More
Trial underway for Medtronic's stent graft system
A 140-patient clinical study has been launched by Medtronic to assess the effectiveness and safety of its Endurant Evo AAA, ...Learn More
IPO could pull in as much as $69M for Calif. surgical lighting firm
An initial public offering has been filed by Invuity with the goal of securing as much as $69 million. ...Learn More
Investor funding brings in $5M for Amarantus
Amarantus BioScience Holdings, which specializes in developing tests and treatments for ophthalmologic, psychiatric and ...Learn More
Voden Medical enters distribution partnership with Linkage Biosciences
Voden Medical Instruments has struck a deal to distribute Linkage Biosciences' genetic tests. ...Learn More
Covance acquisition drives Q1 revenue growth for LabCorp
Laboratory Corp. ...Learn More
Shoulder arthropathy device from FH Orthopedics gets FDA clearance
The Arrow, a reverse shoulder long keel glenoid base plate from French medtech firm FH Orthopedics, has received 510(k) ...Learn More
Raiing Medical unveils smartphone-connected thermometer
Raiing Medical has designed an adhesive temperature monitor and smartphone app that could be used by parents to monitor the ...Learn More
EU approves burn treatment tool from Avita Medical
European regulators have granted Avita Medical CE mark approval for its ReCell, a second-generation device intended for burn ...Learn More
Brazil OKs stent embolic protection technology from InspireMD
The MGuard Prime, a stent embolic protection device from InspireMD, has obtained approval from Brazilian regulators. ...Learn More
FDA labels Maquet's cardiac closure device recall as Class I
A recall involving Maquet Cardiovascular's TigerPaw II, a device intended to occlude the left atrial appendage of the heart ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
The world breaks everyone and afterward many are strong at the broken places.
Ernest Hemingway, ...Learn More
Senate proposal would expedite breakthrough medtech approval
A bill introduced by Sen. Richard Burr, R-N.C., would establish an FDA fast-track program for novel medical devices. ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl commending Sens. ...Learn More
Calif. firm takes in $3M in debt financing
A debt funding round has pulled in $3 million for Gynesonics. ...Learn More
Natera's blood-based prenatal test available in Canada
Natera has struck a deal with LifeLabs Medical Laboratory Services in which the lab will offer Natera's Panorama blood-based ...Learn More
Sanofi, Ypsomed enter injection system development deal
Ypsomed Group, a Swiss-based firm, has struck a deal to produce components for injection pens to be used in French drugmaker ...Learn More
Study shows positive results for Misonix's chronic wound device
Misonix's SonicOne OR, an ultrasonic debridement device, was associated with 42% less blood loss than standard debridement ...Learn More
Study to assess effectiveness of telerobotic ultrasound imaging technology
A study was launched by the Icahn School of Medicine at Mount Sinai with Rush University Medical Center to assess whether ...Learn More
VuCOMP seeks FDA approval for breast tomosynthesis software
VuCOMP is seeking premarket approval for its breast tomosynthesis computer-aided detection software. ...Learn More
Blood glucose monitor from Nipro Diagnostics gets FDA clearance
The True Metrix Air, a device developed by Nipro Diagnostics to read and evaluate blood glucose levels, has received 510(k) ...Learn More
FDA could approve Edwards Lifesciences' replacement heart valve in 2015
The Sapien 3 implant, a next-generation transcatheter aortic valve from Edwards Lifesciences, could get FDA approval this ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
The possible's slow fuse is lit by the imagination.
Emily Dickinson, ...Learn More
Senate subcommittee holds hearing on medical device tax
A hearing to consider repealing the 2.3% tax on medical devices was convened Thursday by the Senate Finance Committee's ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the Senate subcommittee hearing on possible repeal of the ...Learn More
Funding round brings in $18.5M for Spirox
Spirox has raised $18.5 million in a Series B financing round led by Aisling Capital and Venrock. ...Learn More
Maker of genetic tests enters distribution agreements in Thailand, Israel
Deals have been struck by Courtagen Life Sciences in Thailand and Israel for distribution of its next-generation sequencing ...Learn More
Developer of rapid blood assay receives $2.3M boost
Miroculus has secured $2.3 million in the first tranche of seed financing. ...Learn More
Clinical business drives Q1 revenue growth for Cepheid
Cepheid generated $132.6 million in revenue in the quarter ending March 31, up from $106.9 million generated in the same ...Learn More
Guidance for accepting medtech data from foreign trials unveiled by FDA
The FDA has issued guidelines on the criteria for accepting data from clinical trials conducted overseas for use in medtech ...Learn More
FDA clears digital radiography system from Rayence
The RU-3000, a universal digital radiography system from Rayence, has received 510(k) clearance from the FDA. ...Learn More
FDA OKs tomosynthesis option for Siemens Healthcare's mammography device
A digital breast tomosynthesis add-on to Siemens Healthcare’s Mammomat Inspiration technology has been approved by the ...Learn More
Interbody devices from Meditech Spine cleared by FDA
The next generation of Meditech Spine's Talos line of cervical intervertebral fusion devices has received 510(k) clearance ...Learn More
FDA approves prosthetic penile device from Coloplast
The FDA has granted Coloplast approval for the use of its Titan Inflatable Penile Prosthesis in ectopic reservoir placement. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Only a man who knows what it is like to be defeated can reach down to the bottom of his soul and come up with the extra ounce of power it takes to win when the match is even.
Muhammad Ali, ...Learn More
Some Biomet, Zimmer EU products to be acquired by Lima
A deal has been struck by Lima Corporate to acquire some products by Zimmer and Biomet in certain markets after the two ...Learn More
Collaboration aims to develop assays for immunity detection
Toronto-based molecular diagnostics firm Axela is partnering with Pathology Associates Medical Laboratories to develop ...Learn More
Biodesix's proteomic test scores reimbursement win from CareFirst
An agreement announced Wednesday between CareFirst Blue Cross Blue Shield and Biodesix will make Biodesix's VeriStrat ...Learn More
Q1 sales increase for Stryker
Stryker posted a 3.2% increase in consolidated net sales in the first quarter over the same period last year. ...Learn More
Green resigns CEO, president, board chair roles at Harvard Apparatus
David Green has stepped down as president, CEO and chairman of the board at Harvard Apparatus Regenerative Technology but ...Learn More
Drug-device combo targets prostate cancer
Swedish drugmaker LIDDS is negotiating with a manufacturer to produce a drug-device combination that could be a potential ...Learn More
Epilepsy device from Natus Medical cleared by FDA
The FDA has granted Natus Medical 510(k) clearance for its Quantum, an amplifier designed to monitor epilepsy and seizure. ...Learn More
EU expands approval for Medtronic's deep-brain stimulation tools
European regulators have given expanded approval to Medtronic to allow patients implanted with the company's MRI-safe Activa ...Learn More
Group B strep test from Great Basin Scientific scores FDA clearance
A molecular test developed by Great Basin Scientific for diagnosing group B streptococcus bacteria has received 510(k) ...Learn More
Agilent unit resolves issues at Danish plant
The FDA has issued a closeout letter clearing Dako Denmark, a unit of Agilent Technologies. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
He can who thinks he can, and he can't who thinks he can't. This is an inexorable, indisputable law.
Orison Marden, ...Learn More
Study underway for Medtronic's stent graft technology
A 24-patient feasibility study has been launched by Medtronic to assess the effectiveness and safety of its Valiant Mona, an ...Learn More
Boston firm gains $14M in Series B financing
A Series B funding round has brought in $14 million for Tal Medical. ...Learn More
Metamark's urology Dx tools score reimbursement win from Highmark Blue Shield
An agreement announced Tuesday between Highmark Blue Shield and Metamark will make Metamark's prognostic and diagnostic ...Learn More
Sequencing products drive Q1 revenue growth for Illumina
Illumina generated $538.6 million in revenue in the first quarter, up from the $420.8 million generated in the same period ...Learn More
Vietnamese installation of linear accelerator reported by Varian
Vinmec International Hospital in Vietnam has installed a unit of Varian Medical Systems' Clinac iX, a medical linear ...Learn More
Report: Worldwide orthobiologics market could reach $7.9B by 2019
A MicroMarketMonitor report predicts the worldwide market for orthobiologics will hit $7.9 billion by 2019, with a 6.7% ...Learn More
EU approves 4 Dx tests from Invivoscribe
European regulators have granted Invivoscribe Technologies CE mark approval for its four LymphoTrack Dx next-generation ...Learn More
Alcyone Lifesciences' neuro-ventricular device cleared by FDA
The FDA has granted Alcyone Lifesciences 510(k) clearance for its MEMS Cannula, a neuro-ventricular system designed to treat ...Learn More
FDA clears smaller Diamondback 360 system from Cardiovascular Systems
A smaller version of Cardiovascular Systems' Diamondback 360, a technology designed to treat peripheral artery disease, has ...Learn More
Aneurysm device recommendations released by FDA panel
Recommendations including five years of postmarket monitoring and one year of premarket study have been issued by the FDA's ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Every man must do two things alone: He must do his own believing and his own dying.
Martin Luther, ...Learn More
St. Jude Medical to buy Spinal Modulation for $175M
St. ...Learn More
Baltimore medtech firm takes in over $2.9M in debt financing
A debt funding round involving some 30 investors has pulled in more than $2.9 million for CSA Medical. ...Learn More
Molecular Dx firm enters distribution deals in Middle East, Italy
Curetis, a German molecular diagnostics company, has struck distribution deals in the Middle East and Italy for its Unyvero, ...Learn More
Hurel enters partnership with Optivia Biotechnology
Hurel, a North Brunswick, N.J., cell-based test company, has entered into a marketing and technology collaboration with ...Learn More
Getinge's sales rise in Q1
Getinge posted a 19% increase in year-over-year sales in the first quarter, bringing in $775 million. ...Learn More
EU patent covering silver coating system issued to aap Implantate
A European patent has been secured by aap Implantate for its silver coating technology designed for medical implants as well ...Learn More
Emergency cannula from CardiacAssist approved by EU
European regulators have granted CardiacAssist CE mark approval for its PROTEK Duo, a minimally invasive emergency cannula ...Learn More
House bill would roll back medical device tax
Rep. Alma Adams, D-N.C., has introduced a bill that would repeal the 2.3% excise tax on medical devices. ...Learn More
FDA approves 2 defibrillators from Biotronik
The FDA has granted Biotronik approval for its Inventra DX, an implantable, ultra-high-energy cardioverter defibrillator. ...Learn More
U.S., Canadian regulators approve picosecond laser for treating pigmented lesions
The FDA has granted Syneron Candela expanded approval for its PicoWay, a picosecond laser previously approved for use in ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22 | Washington, D.C. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
We all need people who will give us feedback. That's how we improve.
Bill Gates, businessman and ...Learn More
Trial underway for Boston Scientific's renal denervation device
A 100-patient, multisite study has been launched by Boston Scientific to test the efficacy of Vessix, its renal denervation ...Learn More
Avera Health, Theranostics expand proteomic panel deal
Theranostics Health has entered into an expanded commercial and development deal with South Dakota-based Avera Health for ...Learn More
University enters colon cancer Dx technology deal with DiaCarta
The University of Potsdam in Germany has agreed to license its noninvasive method of diagnosing colon cancer to Hayward, ...Learn More
OpGen appoints 2 new execs
Kevin Krenitsky, who previously served as chief commercial officer at Foundation Medicine, has been tapped to serve as ...Learn More
Arteriovenous graft from Vascular Flow shows positive results in trial
A European study showed promising results for Vascular Flow Technologies' Spiral Flow, an arteriovenous graft that copies ...Learn More
Sunshine Heart asked to adjust protocol for heart device trial
The FDA has asked Sunshine Heart to make changes to its protocols for the multisite study of its C-Pulse, a heart failure ...Learn More
Cell-based analysis system from Fluxion debuts in U.S.
The IsoFlux EMT enrichment system, an instrument designed to separate rare circulating tumor cells from samples of blood, ...Learn More
Taiwan to implement changes to medtech registration, approval
Changes to the registration and approval of medtech products are to be enforced by Taiwanese regulators starting July 1. ...Learn More
Presbyopia device from AcuFocus lands FDA nod
The Kamra inlay system, a corneal implant developed by AcuFocus to enhance vision in patients suffering from presbyopia, has ...Learn More
Abbott's OTC glucose monitor approved by FDA
The FDA has granted Abbott Laboratories approval for its FreeStyle Precision Neo, an over-the-counter tool designed to ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
There's only one corner of the universe you can be certain of improving, and that's your own self.
Aldous Huxley, ...Learn More
Sanford Health signs stent graft technology deal with Medtronic
Sanford Health has agreed to license its stent graft system, a technology that treats thoracoabdominal aortic aneurysms, to ...Learn More
Funding round pulls in $9.6M for Ortho Kinematics
A Series C equity funding round has brought in $9.6 million for health care diagnostics firm Ortho Kinematics. ...Learn More
Masimo's oximetry tool to be part of CapsuleTech's patient monitoring system
A partnership was formed between CapsuleTech and Masimo to incorporate the latter's SET Measure-through Motion and Low ...Learn More
Q4 revenue increases for Transgenomic
Transgenomic generated $7.7 million in revenue in the quarter ending Dec. ...Learn More
Researchers working on cellphone-based malaria diagnostics
A rapid-response, cellphone-based diagnostic test for malaria is being developed by researchers from Michigan State ...Learn More
SpineFrontier's device used in anterior cervical disc fusion in Va.
A patient with cervical stenosis and cervical spinal spondylolis at Newport News-based Bon Secours Mary Immaculate Hospital ...Learn More
Group A strep test from Focus Diagnostics scores FDA clearance
The Simplexa Group A Strep Direct, a PCR test developed by Focus Diagnostics, received 510(k) clearance from the FDA. ...Learn More
EU approves HIV-1 assay from Cepheid
The Xpert HIV-1 Qual, a qualitative HIV-1 test developed by Cepheid for early diagnosis in infants and individuals who are ...Learn More
CAS Medical Systems gains expanded FDA approval for oximeter
The FDA has granted CAS Medical Systems expanded labeling approval for its Fore-Sight Elite tissue oximeter to include ...Learn More
Cervical cancer test from Cancer Genetics lands conditional OK in N.Y.
The New York State Department of Health has given Cancer Genetics conditional licensure to expand its push for wider use of ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
If you are irritated by every rub, how will your mirror be polished?
Rumi, poet and ...Learn More
Ortho Kinematics gains nearly $10M in Series C financing
Austin, Texas-based Ortho Kinematics has obtained almost $10 million in a Series C funding round that includes Medtronic as ...Learn More
Novation enters group purchasing deal with RTI Surgical
Novation, a health care group purchasing organization, has struck a deal giving its more than 100,000 members access to RTI ...Learn More
Frankenman, Boston Scientific enter endoscopic products development deal
Boston Scientific said it has struck a strategic partnership with Frankenman Medical Equipment to develop and produce ...Learn More
Analysis: U.S. market for biocompatible materials to hit $5.5B in 2018
An analysis by ReportBuyer predicts the biocompatible materials market in the U.S. ...Learn More
Nihon Kohden America appoints new CEO
Dr. Constantine Wilson has been promoted from chief operating officer to CEO of Irvine, Calif.-based Nihon Kohden America. ...Learn More
Shoulder fracture cage from Conventus scores FDA clearance
The PH Cage, a shoulder fracture cage developed by Conventus Orthopaedics that expands within the bone, has received 510(k) ...Learn More
BioFire files de novo submission for encephalitis, meningitis Dx panel
BioMerieux unit BioFire has filed a de novo submission with the FDA for its FilmArray Meningitis/Encephalitis Panel. ...Learn More
EU approves robotic PAD catheter from Hansen
European regulators have granted Hansen Medical CE mark approval for its 10-French Magellan, a robotic catheter designed to ...Learn More
EU approves HCV viral load test from Cepheid
The Xpert HCV Viral Load, a test developed by Cepheid to confirm and monitor hepatitis C virus infection, has received the ...Learn More
Perseon gains expanded FDA approval for ablation device
The FDA has granted Perseon expanded approval for its MicroThermX microwave ablation technology, which previously was ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Fear defeats more people than any other one thing in the world.
Ralph Waldo Emerson, ...Learn More
Cyberonics-Sorin deal approved by U.S. regulators
The pending all-stock merger of Cyberonics with Italy's Sorin Group for $1.4 billion has received approval from antitrust ...Learn More
Termination date for Zimmer-Biomet deal extended to July 23
The termination date for Zimmer Holdings' pending merger with Biomet for $13.4 billion has been moved from April 24 to July ...Learn More
Funding round brings in $3.3M for U.K.-based firm
A Series A financing round pulled in $3.3 million for Congenica. ...Learn More
Equity funding round pulls in $2.3M for Novacyt
A private equity placement brought in $2.3 million for Paris-based Novacyt. ...Learn More
Certified public accountant named CFO of Tegra Medical
Craig Campbell, a certified public accountant with almost 25 years of finance and accounting experience, was tapped to serve ...Learn More
Helius gets FDA nod to begin trial enrollment for brain stimulator device
The FDA has given Helius Medical approval to enroll patients with chronic balance problems caused by mild to moderate injury ...Learn More
Anterior lumbar retractor from TeDan Surgical debuts in U.S.
The Phantom AL Retractor System, a device intended to provide better visualization during anterior lumbar interbody fusion ...Learn More
EU approves transcatheter pacing technology from Medtronic
European regulators have granted Medtronic CE mark approval for its Micra device, a leadless transcatheter pacing system. ...Learn More
IDE application for bone scaffold submitted by Anika Therapeutics
An investigational device exemption application has been filed with the FDA by Anika Therapeutics to begin a late-stage ...Learn More
Waters instrument approved for in vitro Dx use in China
Waters' Acquity UPLC I-Class IVD/Xevo TQ-S IVD LC-MS technology was approved by China's Food and Drug Administration for use ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Have patience. All things are difficult before they become easy.
Saadi, ...Learn More
J&J unit, Ichor Medical collaborate on hepatitis B drug-device combo
San Diego-based Ichor Medical Systems has entered into a licensing and development deal with Janssen Pharmaceuticals, a unit ...Learn More
Funding round brings in $15M for ReCor Medical
A Series D financing round led by Otsuka Holdings pulled in $15 million for ReCor Medical. ...Learn More
Funding round brings in $1.5M for Israel-based firm
A funding round pulled in $1.5 million for Leviticus Cardio. ...Learn More
Maker of cancer-screening technology bought by Roche
Roche Holding has agreed to pay an undisclosed sum to buy CAPP Medical, a California-based firm that has developed a system ...Learn More
Firm wins $1.5M grant for HIV/AIDS assay
The NIH awarded Rheonix a phase II grant worth $1.5 million under its Small Business Innovation Research program to continue ...Learn More
EverGene, Affymetrix to team up in genotyping service deal in Japan
A deal was reached between Affymetrix and EverGene to cooperate on a personal genomics service in Japan. ...Learn More
Bone fracture device from IlluminOss shows positive results in study
Research in the Journal of Biomedical Materials Research Part B: Applied Biomaterials showed promising results for ...Learn More
Smartphone-enabled device shows promise in detecting cancer
A study in the Proceedings of the National Academy of Sciences describes a device that could be used along with smartphones ...Learn More
FDA grants breakthrough status to peanut allergy patch
The Viaskin Peanut, an electrostatic patch developed by DBV Technologies, has obtained breakthrough designation as a ...Learn More
FDA labels Intuitive Surgical's drapes recall as Class II
A recall initiated by Intuitive Surgical involving about 440,000 Microtek Medical drapes has been labeled Class II by the ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Vanity and pride are different things, though the words are often used synonymously. A person may be proud without being vain. Pride relates more to our opinion of ourselves, vanity to what we would have others think of us.
Jane Austen, ...Learn More
Funding round brings in $20M for EBR Systems
A financing round involving former Medtronic executive Stephen Mahle has pulled in $20 million for EBR Systems. ...Learn More
AngioDynamics gains license for EmboMedics' microspheres
EmboMedics has agreed to license its resorbable microspheres to AndioDynamics, a Latham, N.Y.-based firm, for $11 million. ...Learn More
Improved sales productivity drives Q1 revenue growth for Bacterin
Bacterin generated between $9.4 million and $9.5 million in total net revenue in the first quarter, a 5% to 7% increase over ...Learn More
Q4 sales jump for molecular imaging firm
Advanced Accelerator Applications generated $24.6 million in sales for the fourth quarter of 2014, compared with $18.6 ...Learn More
Finance veteran named CFO of Cepheid
Ilan Daskal, who has over 20 years of experience in finance, has been tapped to serve as the CFO of Cepheid. ...Learn More
Trial enrollment for Vertos Medical's back pain treatment completed
Vertos Medical has completed patient enrollment for a multisite, randomized and controlled trial of its minimally invasive ...Learn More
HemCon wins approval for wound care products in China
Chinese regulators have granted Portland, Ore.-based HemCon Medical Technologies approval to market its entire wound care ...Learn More
Senate hearings on repealing medical device tax planned
Hearings on repealing the 2.3% tax on medical devices could happen in the Senate Finance Committee in the near future. ...Learn More
FDA approves study of CardiAQ's mitral valve implant
CardiAQ Valve Technologies has received an investigational device exemption from the FDA to conduct an early feasibility ...Learn More
Medtech price control order endorsed in India
India's Task Force on Medical Devices has endorsed the inclusion of medical devices in the Essential Commodities Act and ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Iron rusts from disuse; water loses its purity from stagnation ... even so does inaction sap the vigor of the mind.
Leonardo da Vinci, artist and ...Learn More
Final guidance for expedited medtech approval unveiled by FDA
The FDA has issued final guidelines on policies designed to expedite the approval of medtech products for irreversibly ...Learn More
Molecular Dx lab acquired by Rosetta in $2M deal
Rosetta has agreed to pay $2 million in cash plus 500,000 ordinary shares to buy PersonalizeDx, a molecular diagnostics ...Learn More
Report: Orthobiologics market in North America to reach $2.4M by 2019
A MicroMarketMonitor report predicts the North American market for orthobiologics will hit $2.4 million by 2019, with a 7.7% ...Learn More
Q1 revenue increases for SpineGuard
SpineGuard posted a 47% increase in year-over-year revenue during the first quarter, driven by the higher sales of its ...Learn More
Company veteran named chief scientific officer of Osiris
Alla Danilkovitch has been appointed chief scientific officer of Osiris Therapeutics, a company focused on regenerative ...Learn More
FDA clears IV monitoring tool from Va. firm
The FDA has given ivWatch 510(k) clearance to market the ivWatch Model 400, a device that can spot adverse extravasation and ...Learn More
Directional atherectomy tool from Medtronic debuts in U.S.
The HawkOne, a directional atherectomy system developed to address extremely calcified lesions in lower extremities' blood ...Learn More
Firm seeks humanitarian exemption for biofiltration system
The FDA has been asked by Aethlon Medical to grant its Hemopurifier biofiltration system a humanitarian device exemption ...Learn More
EU approves Sophia Genetics' tool to detect BRCA gene variations
European regulators have granted Sophia Genetics the CE-IVD mark for its device that can diagnose copy number variations in ...Learn More
Canada approves heart pump from HeartWare
Health Canada has given Massachusetts-based HeartWare the go-ahead to market its implantable left ventricular assist device ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Each man must look to himself to teach him the meaning of life. It is not something discovered; it is something molded.
Antoine de Saint-Exupery, ...Learn More
Stakeholders debate merits of speeding up regulatory review of devices, drugs
Former FDA Commissioner Margaret Hamburg has raised concerns about congressional efforts to speed up the drug and medical ...Learn More
Debt funding round nets $7.5M for DxTerity
Debt financing from SWK Funding will bring in as much as $7.5 million for DxTerity Diagnostics. ...Learn More
Atlas eyes $5M in financing to monetize spinal implant systems
Atlas Spine is hoping to raise $5 million in a Series B funding round involving OfferBoard Securities. ...Learn More
Microbiome, Biocartis team up in rapid blood assay deal
A global partnership deal was reached between Microbiome and Biocartis to develop a polymerase chain reaction-based rapid ...Learn More
2 Japanese medtech firms widen gastroenterology, urology deal in U.S.
Japanese device-makers Olympus and Terumo have completed a deal to broaden their business partnership in the U.S. ...Learn More
DARPA backs development of blood-sampling device
The Defense Advanced Research Projects Agency awarded Tasso and its partner GenTegra a grant worth $2.9 million to advance ...Learn More
Biotronik records first U.S. patient implanted with pacemaker system
A patient at Lenox Hill Hospital in New York was the first in the U.S. ...Learn More
FDA OKs diabetic retinal screening software
Intelligent Retinal Imaging Systems, software that is used for retinal screening, has obtained FDA clearance to screen for ...Learn More
Surgical navigation tool from Synaptive Medical scores FDA clearance
The FDA has granted Synaptive Medical clearance for its BrightMatter Guide, a surgical navigation system for use during ...Learn More
Ablation tool from Perseon gets FDA nod
The MicroThermX, a microwave ablation device from Perseon, has received 510(k) clearance from the FDA. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Never be bullied into silence. Never allow yourself to be made a victim. Accept no one's definition of your life; define yourself.
Harvey Fierstein, actor and ...Learn More
Trial underway for Medtronic's ablation device
A one-year, 1,000-patient registry study was launched by Medtronic to test the use of its Gold device, a pulmonary vein ...Learn More
Equity funding round pulls in more than $5M for Minn. firm
A private equity offering has brought in over $5 million for Pursuit Vascular, according to a recent regulatory filing. ...Learn More
N.J. molecular Dx firm obtains funding boost
A Series A funding round led by Prime Value Capital Management has brought in an undisclosed sum for Admera Health. ...Learn More
South Korean firm launches U.S. division in Calif.
Seegene Technologies, the U.S. subsidiary of South Korean firm Seegene, has opened in Concord, Calif. ...Learn More
Study to look at health care apps and devices for seniors
AARP announced plans to collaborate with Pfizer and UnitedHealthcare on an initiative to determine how people ages 50 and ...Learn More
Video system monitors vital signs using skin color changes
Rice University researchers have developed DistancePPG, a video system to measure pulse and breathing rate by analyzing ...Learn More
Advanced Breath Diagnostics' gastroparesis test lands FDA nod
The FDA has granted Brentwood, Tenn.-based Advanced Breath Diagnostics approval to market its Gastric Emptying Breath Test, ...Learn More
ReShape allowed to bypass FDA advisory panel meeting for weight-loss device
A requirement that would have ReShape Medical attend an advisory committee meeting for the premarket approval filing of its ...Learn More
Hospira receives FDA warning over manufacturing practices at Italian plant
The FDA has issued a warning letter to Hospira over manufacturing practice violations at its facility in Liscate, Italy. ...Learn More
FDA labels Zimmer's knee implant recall as Class II
A recall initiated by Zimmer involving 11,658 Persona Trabecular Metal Tibial Plate knee implants has been labeled Class II ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Indecision and delay are the parents of failure.
George Canning, ...Learn More
Funding round brings in $55.5M for Natera
Natera has obtained $55.5 million in a private financing round led by Sofinnova Ventures. ...Learn More
IPO could pull in up to $35.2M for microbial genetics analysis firm
OpGen filed plans Monday with the U.S. ...Learn More
Dentistry school receives grant to develop test for HIV antibodies, viral RNA
Researchers from New York University College of Dentistry have been awarded a $335,000 grant from the National Institutes of ...Learn More
Report: Worldwide nonfusion spinal device market poised for growth
A Medical Market Research report forecasts the worldwide market for nonfusion spinal devices will grow through 2019. ...Learn More
Cogentix to move production facility to Westborough, Mass.
Cogentix Medical said it intends to transfer its manufacturing plant in Natick, Mass., to a 24,400-square-foot facility in ...Learn More
U.S. patent covering bone matrixes issued to Bacterin
Bacterin has secured a U.S. patent for some demineralized bone matrixes in its OsteoSponge devices. ...Learn More
FDA clears surgical hydrogel from Augmenix
The FDA has granted Augmenix clearance for its SpaceOAR hydrogel system under the agency's de novo program. ...Learn More
Ethicon gains expanded FDA approval for surgical sealant patch
The FDA has granted Ethicon expanded approval for its Evarrest, a fibrin sealant patch previously approved as an adjunct ...Learn More
Blood glucose monitor from Abbott approved by Indian regulators
Indian regulators have granted Abbott approval for its FreeStyle Libre Pro Flash, a wearable sensor device that can monitor ...Learn More
China clears Cytori to market regenerative cell technology
Cytori Therapeutics' Celution System has obtained clearance from Chinese regulators. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Just remember, once you're over the hill you begin to pick up speed.
Charles Schulz, ...Learn More
Medtronic reports positive trial results for peripheral stent
A 287-patient, three-year multisite study showed promising results for Medtronic's EverFlex, a self-expanding nitinol stent ...Learn More
Medtronic gains license for artificial pancreas technology
DreaMed Diabetes, a medtech firm in Israel, has agreed to license its GlucoSitter artificial pancreas system to Medtronic. ...Learn More
Former Hologic executive joins Royal Philips as global imaging CEO
Rob Cascella has been tapped to serve as CEO of Royal Philips' global diagnostic imaging business. ...Learn More
World Institute of Pain founder named to Stimwave's medical advisory board
Dr. ...Learn More
Wearable defibrillator from Zoll shows positive results in study
A study in the journal Heart Rhythm showed promising results for Zoll Medical's LifeVest, a cost-effective, wearable ...Learn More
Immunexpress develops rapid diagnostic test for sepsis
Immunexpress has developed a diagnostic tool that can screen for sepsis in just an hour. ...Learn More
Idaho firm designs smartphone-based autism diagnosis tool
Behavior Imaging's new app, Naturalistic Observation Diagnostic Assessment, can speed up the diagnosis of children who are ...Learn More
Microbial ID tool from Bruker scores FDA clearance
An expanded variant of the MALDI Biotyper, a clinical microbiology technology developed by Bruker, has received 510(k) ...Learn More
Medtronic agrees to pay $4.4M to settle spinal surgery device lawsuit
Medtronic has reached a $4.4 million settlement deal with the federal government to resolve a lawsuit accusing the firm of ...Learn More
FDA labels Philips' CT scanner recall as Class II
A recall initiated by Philips Healthcare involving 424 CT scanners has been labeled as Class II by the FDA. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Ill habits gather by unseen degrees, as brooks make rivers, rivers run to seas.
Ovid, ...Learn More
Dutch diabetes clinic and research center acquired by Medtronic
Medtronic has purchased Diabeter, a Dutch clinic and research facility for diabetes patients, for undisclosed terms. ...Learn More
Roche's bid to buy majority stake in cancer Dx firm gets shareholder OK
Roche's plan to acquire a majority stake in Foundation Medicine, a cancer molecular diagnostics company based in Cambridge, ...Learn More
Miracor widens U.K. presence with new sales office, 2 heart device trials
Miracor Medical Systems, the Austrian maker of the PICSO impulse system, has opened a new sales unit in Manchester, England. ...Learn More
Firm wins $1.5M grant for antibiotic-resistant TB test
The NIH awarded InSilixa a phase II grant worth $1.5 million under its Small Business Innovation Research program for the ...Learn More
Report: Surgical microscope market to hit $806.6M by 2020
A MarketsandMarkets report predicts the market for surgical microscopes will be worth $806.6 million by 2020, with a ...Learn More
Report: Worldwide hip implant market poised for growth
A Medical Market Research report forecasts the worldwide hip implant market will see a 2.98% compound annual growth rate ...Learn More
FDA expands approval of AirStrip fetal, maternal monitoring kit
A second FDA clearance was granted to AirStrip for its wireless maternal and fetal monitoring kit, Sense4Baby. ...Learn More
Group A strep test from Alere scores FDA clearance
The i Strep A molecular test, developed by Alere, has received 510(k) clearance from the FDA. ...Learn More
Heart valve from On-X Life gets OK on expanded label from FDA
The FDA has granted On-X Life Technologies expanded labeling approval for its aortic heart valve to include reduced ...Learn More
EU approves home dialysis system from Baxter
European regulators have granted Baxter International CE mark approval for its HomeChoice Claria, a home peritoneal dialysis ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Honest disagreement is often a good sign of progress.
Mahatma Gandhi, social ...Learn More
Maker of biliary devices acquired by Boston Scientific in $62.5M deal
Boston Scientific has agreed to pay $62.5 million upfront to acquire Mountain View, Calif.-based Xlumena and its Hot Axios ...Learn More
Vision-Sciences concludes merger with Uroplasty to form Cogentix
The merger combining Vision-Sciences and Uroplasty into Cogentix Medical was completed Wednesday. ...Learn More
Deal gives Orthofix option to buy migraine-device firm
Orthofix has struck a deal that includes an 18-month option to purchase eNeura and its SpringTMS, an FDA-approved device ...Learn More
Funding round brings in $3.4M for Boston-based Dx firm
A private placement pulled in $3.4 million for MetaStat. ...Learn More
Higher test volume drives Q4 revenue growth for GeneNews
GeneNews generated $557,457 in revenue in the quarter ending Dec. ...Learn More
Studies underway for Luminex's Aries diagnostic platform, HSV assay
Luminex has begun its clinical trials for the Aries molecular diagnostics system, a lower-throughput sample-to-answer ...Learn More
Bone fixation device from BioMedical Enterprises debuts
The Speed Titan, a nitinol-based bone fixation system, has been launched by BioMedical Enterprises. ...Learn More
FDA meeting to discuss computer modeling's use in medtech development
The use of computational modeling and simulation strategies in medical device evaluation and development will be discussed ...Learn More
Upgrades for Lensar's cataract laser device cleared by FDA
Streamline, the collective name for Lensar's five new application technologies for its Lensar Laser System, has received ...Learn More
New York Genome Center gets OK to offer clinical exome tests in state
The New York State Department of Health has granted the New York Genome Center approval to offer its clinical exome test in ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Attach yourself to those who advise you rather than praise you.
Nicolas Boileau-Despreaux, poet and literary ...Learn More
Medtronic's heart valve obtains wider approval from FDA
The FDA has granted Medtronic expanded approval for use of its CoreValve system, a transcatheter aortic valve-replacement ...Learn More
DePuy gains exclusive rights to market Radlink's imaging system
A global sales deal has been struck between DePuy Synthes and Radlink to allow DePuy to exclusively market Radlink's Galileo ...Learn More
Quest Diagnostics forms joint venture with contract research firm
A joint venture was formed that will merge the clinical trial laboratory businesses of Quest Diagnostics and Quintiles ...Learn More
Stryker to build center of excellence in Ireland
Stryker is planning to set up an international center of excellence in Cork, Ireland. ...Learn More
Q3 net sales show growth for Orthofix
Orthofix generated $101 million in net sales during the company's fiscal year 2014 third quarter, which is an increase of ...Learn More
Former executive at Analogic joins Insulet as CFO
Michael Levitz has been tapped to serve as chief financial officer at Insulet. ...Learn More
Hansen enters partnership with China National Medical Device
Hansen Medical has entered into a distribution deal with China National Medical Device for its Magellan surgical robot ...Learn More
Tenn. firm enters distribution deals with 25-plus global partners
Knoxville, Tenn., firm EDP Biotech has struck deals with over 25 distribution partners in South America, Asia and Europe ...Learn More
SynCardia gets FDA OK to launch study of heart failure device
SynCardia Systems has received an investigational device exemption from the FDA to conduct a trial to evaluate the use of ...Learn More
China clears Hangzhou Berry Genomics to market prenatal test
The NextSeq CN500, a noninvasive prenatal test developed by Hangzhou Berry Genomics, has obtained premarket clearance from ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
To praise is an investment in happiness.
George Adams, newspaper ...Learn More
Zimmer-Biomet deal approved by EU regulators
The pending merger of Zimmer Holdings with Biomet for $13 billion has received approval from antitrust regulators in Europe. ...Learn More
Merger of Vision-Sciences, Uroplasty gets shareholder approval
Shareholders approved an all-stock merger combining Uroplasty and Vision-Sciences into Cogentix Medical. ...Learn More
Exact Sciences' colorectal cancer test scores reimbursement win from Tufts Health
The use of Exact Sciences' Cologuard, a noninvasive stool-based test that screens for colorectal cancer markers, will be ...Learn More
Funding round brings in nearly $1.27M for Saphena Medical
Saphena Medical has raised almost $1.27 million via a Series B preferred stock sale, bringing the company closer to its $3 ...Learn More
Novation enters group purchasing deal with Benvenue
Novation, a health care group purchasing organization, has struck a deal giving its more than 100,000 members access to ...Learn More
External fixation device from Zimmer debuts in U.S.
The XtraFix, a modular instrument that facilitates external fixation procedures, was launched by Zimmer. ...Learn More
D-Eye unveils smartphone-connected retinal imaging device
D-Eye has unveiled a new system designed to be affixed to a smartphone to capture high-resolution retinal images and videos. ...Learn More
Insulin management system from Medtronic approved in U.K.
The U.K. ...Learn More
Mass spectrometry tool from Thermo Fisher submitted to FDA as Class I device
The Prelude LX-4 MD HPLC, a mass spectrometry instrument, has been registered by Thermo Fisher Scientific with the FDA as a ...Learn More
Heart valve from Medtronic wins approval in Japan
Japanese regulators have given Medtronic approval to market its CoreValve, a transcatheter aortic valve-replacement device, ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
The most common way people give up their power is by thinking they don't have any.
Alice Walker, ...Learn More
Pentagon extends supply contract with Royal Philips for $77.2M
The Defense Department has renewed its contract with Royal Philips for the sixth one-year option on a nine-year deal, for an ...Learn More
J&J partners with Google to develop surgical robots
Google and Johnson & Johnson have agreed to team up on the creation of a robotic surgical platform that combines ...Learn More
Funding round brings in $3.25M for surgical mesh maker
Kips Bay Medical has obtained $3.25 million in a private placement that includes its founder, Manny Villafana, as an ...Learn More
Veracyte, Sanofi firm enter marketing deal for gene expression test
Genzyme, a Sanofi firm, struck a five-year deal that started Jan. ...Learn More
Venture capitalist named to Avedro's board
David McIntyre, a partner in the health care venture capital firm Apple Tree Partners, has been tapped to serve on the board ...Learn More
Pivotal study begins for Obalon's weight-loss device in U.S.
Obalon Therapeutics has started a set of pivotal studies to test the use of its ingestible gas-filled balloon in losing ...Learn More
Bioness tests neuromodulation device for overactive bladder
Bioness has kicked off a six-month study in Canada that aims to test its minimally invasive StimRouter Neuromodulation ...Learn More
Fetal micro-pacemaker lands humanitarian exemption from FDA
The FDA has granted a humanitarian device exemption approval for a fully implantable fetal micro-pacemaker designed by ...Learn More
Voyant receives FDA OK for TraumaCad Mobile tool
Voyant Health has obtained FDA clearance to market the mobile version of its TraumaCad solution. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
You are surrounded by hundreds of people more timid than you are.
Fred Barton, ...Learn More
Colo.-based maker of hearing aid implants acquired by Medtronic
Medtronic has concluded the purchase of Sophono, a Boulder, Colo.-based maker of magnetic hearing aid implants, for ...Learn More
Radlink signs hip imaging deal with J&J unit
Radlink has agreed to license its Galileo positioning system to DePuy Synthes, a Johnson & Johnson unit. ...Learn More
Medtech startup pulls in $1.52M from funding round
An ongoing financing round being led by Cultivation Capital has brought in $1.52 million for Cardialen. ...Learn More
Atlas technology drives Q4 revenue growth for Roka Bioscience
Roka Bioscience generated $1.4 million in revenue in the quarter ending Dec. ...Learn More
ISO certification granted to MolecularMD's quality management system
The British Standards Institution has granted MolecularMD certification for the company's quality management system for its ...Learn More
Advanced bone matrix from Stryker debuts in U.S.
The BIO4, a viable bone matrix with endogenous bone-forming cells, is being launched by Stryker at the American Academy of ...Learn More
FDA clears external fixation technology from Wright Medical
The Salvation, an external fixation system developed by Wright Medical for ankle and foot surgeries, has received 510(k) ...Learn More
Stryker's spinal repair device cleared by FDA
The FDA has given Stryker 510(k) clearance to market the Lite Plate System, a lateral and anterior lumbar plate technology ...Learn More
EU approves biotherapy monitoring tool from Theradiag
European regulators have granted Theradiag, a French diagnostics firm, CE mark approval for its Stelara biotherapy ...Learn More
Instructions for cleaning duodenoscopes released by Olympus
Olympus has urged health providers to adopt as quickly as possible the new instructions it issued Thursday for cleaning ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's easy to have faith in people who have already proved themselves. It's much tougher to believe in people before they have proved themselves. But that is the key to motivating people to reach their potential.
John Maxwell, writer and motivational ...Learn More
Zimmer-Biomet deal approved by Japanese regulators
The pending merger of Zimmer with Biomet for $13.35 billion has received approval from antitrust regulators in Japan. ...Learn More
Maker of cell therapy device for diabetes gains $44M in Series A financing
Semma Therapeutics has obtained $44 million in a Series A funding round that includes Medtronic as an investor. ...Learn More
Intellirod Spine gains rights to X-spine Systems' spinal implants
Licensing and distribution deals were struck between Intellirod Spine and X-spine Systems to give Intellirod the right to ...Learn More
Amgen, Dako expand collaboration on companion Dx development
Dako has entered into an expanded development deal with Amgen. ...Learn More
J&J unit, Royal Philips enter partnership for development of handheld blood test
Royal Philips has struck a development deal with Janssen Pharmaceutica, a unit of Johnson & Johnson. ...Learn More
Boston Scientific's anti-stroke device debuts in U.S.
Doctors at Cedars-Sinai Medical Center in Los Angeles and Providence Saint John's Health Center in Santa Monica, Calif., ...Learn More
Robot-assisted hip-replacement system from Stryker debuts in U.S.
A total hip arthroplasty tool for the Mako robotic surgical platform was launched by Stryker during a conference of the ...Learn More
Zyga records first commercial use of updated spine device in U.S.
A patient at Reno Orthopaedic Clinic in Nevada was the first to undergo surgery using Zyga Technology's updated SImmetry ...Learn More
FDA clears spinal fixation technology from K2M
The NILE Alternative Fixation Spinal System, developed by K2M, has received 510(k) clearance from the FDA. ...Learn More
Vital Art and Science receives second FDA clearance for vision test
A second FDA clearance was granted to Vital Art and Science for its smartphone eye test application called myVisionTrack. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Never interrupt someone doing something you said couldn't be done.
Amelia Earhart, ...Learn More
Funding round brings in $11M for Osprey Medical
A private placement pulled in $11 million for Osprey Medical. ...Learn More
Deal to give Global Enterprises majority stake in molecular Dx firm
A deal was struck Tuesday by diversified holding firm Global Enterprises Group to acquire a majority stake in Predictive ...Learn More
Fund to support medtech, other life-science firms introduced in Poland
The Joint Polish Investment Fund I, a venture capital fund devoted to investments in life-science companies, has been ...Learn More
Teleflex records first surgery using percutaneous surgical system
A patient at the Cleveland Clinic was the first to undergo a procedure using Teleflex's Percuvance Percutaneous Surgical ...Learn More
Carestream partners with medical specialists to develop 3D extremity-imaging device
A 3D conebeam CT scanner for extremities is being developed by Carestream Health in collaboration with specialists in ...Learn More
Virtual-reality platform from EchoPixel debuts in U.S.
The True3D Viewer, a platform that can change anatomical data into virtual-reality images, was launched by EchoPixel. ...Learn More
Production milestone hit by Vistek Medical for medtech components
Vistek Medical has produced 2 million medical components and implants, which is a production milestone for the company. ...Learn More
Proposal to repeal medical device tax introduced in Senate
A bill that would repeal the 2.3% excise tax on medical devices and increase taxes on oil and gas companies to replace the ...Learn More
Rapid Ebola test from Cepheid receives FDA approval for emergency use
Cepheid's Xpert Ebola, a PCR-based test for the Ebola virus, has been given authorization for emergency use by the FDA. ...Learn More
N.J. approves use of 2 molecular Dx tests from Admera Health
The New Jersey Department of Health has approved the clinical use of Admera Health's OncoGxOne and PGxOne Plus ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
It does not matter how slowly you go as long as you do not stop.
Confucius, philosopher and ...Learn More
Abiomed's blood pump system lands FDA nod
The FDA has granted Abiomed approval to market its Impella 2.5 System, a miniature blood pump that preserves heart ...Learn More
Series C round pulls in $19M for OrthoSensor
OrthoSensor has obtained $19 million in a Series C financing round of preferred stock. ...Learn More
Simplify Medical acquired by Australian private-equity shop
M.H. ...Learn More
Former Qiagen Marseille managers set up new cancer Dx firm
The former executive management team of Qiagen Marseille has established HalioDx, an immuno-oncology diagnostics company, ...Learn More
Benvenue Medical announces new CFO
John Dahldorf has been appointed chief financial officer of Benvenue Medical, a maker of minimally invasive devices for ...Learn More
Diabetes technology improves, but patients still need support
Diabetes self-care has benefited from technologies such as the continuous glucose monitor, lancet-based glucose meters that ...Learn More
Cryoablation device from AtriCure being promoted for new indication
CryoIce, a cryoablation device from AtriCure, is being promoted for temporary relief of pain in cardiac and thoracic surgery ...Learn More
AdvaMed commends budget proposal that includes medical device tax repeal
A congressional budget resolution that includes language to repeal the 2.3% excise tax on medical devices was praised by ...Learn More
For more:
Read the entire statement from AdvaMed Senior Executive Vice President JC Scott about the possible repeal of the medical ...Learn More
Canada OKs next-generation sequencing system from Illumina
A medical device license was granted by Health Canada to Illumina's MiSeqDx tool, a next-generation sequencing system, ...Learn More
EU approves Oncomine fusion panel from Thermo Fisher
European regulators have granted Thermo Fisher Scientific the CE-IVD mark for its Oncomine Solid Tumor Fusion Transcript, a ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Our greatest weakness lies in giving up. The most certain way to succeed is always to try just one more time.
Thomas Edison, ...Learn More
Final guidance for reusable medtech product labeling, instructions unveiled by FDA
The FDA has issued final guidelines governing instructions and labeling for reusable medical devices, as well as guidelines ...Learn More
Drug-device combo maker sets IPO's midpoint price at $40M
SteadyMed Therapeutics offered 4.7 million shares in its initial public offering last week for a midpoint price of $40 ...Learn More
Medtech startup gets $5.9M boost
A funding round involving 52 investors brought in $5.9 million for InterVene, according to a regulatory filing with the ...Learn More
Pa. medtech firm takes in $3M in debt financing
Pennsylvania-based medtech firm Intact Vascular said in a filing with the Securities and Exchange Commission that it has ...Learn More
Calhoun Vision names former Bausch & Lomb exec as new CEO
Rick Heinick, former executive vice president and chief human resources and transformation officer at Bausch & Lomb, was ...Learn More
Sensor-embedded inhaler to track asthma of Ky. patients
The personalized asthma management system from Propeller Health will be used as part of a collaboration between public, ...Learn More
Positive results reported in 2 studies of Sebacia's acne management system
A novel approach using lasers, gold-coated particles and ultrasound to treat acne, developed by the clinical-stage medtech ...Learn More
MRI-safe pacemakers from Biotronik land FDA nod
The FDA granted Biotronik approval to market its dual- and single-chamber ProMRI Eluna pacemakers to be used with its Setrox ...Learn More
FDA clears catheter system from Vascular Pathways
The AccuCath 3.1" BC Midline Catheter, developed by Vascular Pathways for patients with challenged peripheral vasculature, ...Learn More
EU approves STD molecular Dx tests from Becton Dickinson
European regulators have granted Becton Dickinson CE mark approval for its BD Max CT/GC and CT/GC/TV tests. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
I will either find a way or make one.
Hannibal, military ...Learn More
GOP senators include medical device tax repeal in budget proposal
A budget proposal that includes language to repeal the 2.3% excise tax on medical devices was introduced Wednesday by ...Learn More
Funding round brings in $16M for N.J. medtech firm
Svelte Medical Systems has obtained $16 million in a financing round led by New Science Ventures, CNF Investments and the ...Learn More
NanoString's breast cancer Dx test available in Canada
NanoString has struck a deal in which LifeLabs Medical Laboratory Services will offer its Prosigna Breast Cancer Prognostic ...Learn More
Stimwave to expand workforce, move headquarters to Fort Lauderdale, Fla.
Stimwave Technologies is planning to hire 20 more workers as it launches the Freedom Stimulator, an implantable device that ...Learn More
Q4 revenue soars for Veracyte
Veracyte generated $12.2 million in revenue in the quarter ending Dec. ...Learn More
Blue Belt's robotic surgery device debuts in Australia
A patient at Mater Hospital in Sydney was the first in Australia to undergo a procedure using Blue Belt Technologies' Navio ...Learn More
FDA clears advanced PAD testing technology from Semler
A next-generation system developed by Semler Scientific for peripheral artery disease testing has received 510(k) clearance ...Learn More
FDA OKs study of Simplify Medical's artificial cervical disc
Simplify Medical received an investigational device exemption from the FDA to conduct a study comparing its Simplify Disc, ...Learn More
EU approves bone screw system from Silver Bullet
European regulators have granted Silver Bullet Therapeutics CE mark approval for its OrthoFuzIon Cannulated Bone Screw ...Learn More
FDA labels Medtronic's sheath recall as Class I
A recall involving Medtronic's FlexCath Select Steerable Sheath has been categorized by the FDA as Class I. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Ever tried. Ever failed. No matter. Try again. Fail again. Fail better.
Samuel Beckett, ...Learn More
Zimmer-Biomet deal likely to be approved by EU regulators, sources say
The acquisition of Biomet by Zimmer for $13.4 billion is set to receive conditional approval from antitrust regulators in ...Learn More
Growth-stage Dx company gets $4M boost
DiabetOmics has obtained $4 million in a funding round led by Ventureast. ...Learn More
Lucigen pulls in $2.2M from private financing round
A private financing round has brought in $2.2 million for Wisconsin-based Lucigen. ...Learn More
DNA testing company gets funding boost to develop new Dx tests
Spartan Bioscience, an on-demand DNA testing firm, has obtained an investment from Canon USA to finance the development of ...Learn More
MPTronic enters distribution partnership with SST Group
SST Group has struck a deal to exclusively distribute MPTronic's RDM device in Canada and the U.S. ...Learn More
Who are medtech's favorites in Congress?
Check out an analysis of the political donations the medical device industry gave legislators last year. Read the ...Learn More
Report predicts strong growth for wearables market through 2020
An IndustryARC report predicts an annual growth rate of 21.3% through 2020 for the global wearable medical devices market. ...Learn More
New deadline set for comments on drug-device combo GMP rules
The FDA has moved the deadline from March 30 to April 29 for comments on the draft good manufacturing practices guidance for ...Learn More
Requirements for Class IV medtech products updated in South Korea
The Ministry of Food and Drug Safety in South Korea will require clinical data for a large number of Class IV medical ...Learn More
Peripheral stent from Medtronic gets expanded approval from FDA
The FDA has granted Medtronic expanded approval for use of its Protege GPS stent in treating peripheral artery disease ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
People won't have time for you if you are always angry or complaining.
Stephen Hawking, theoretical ...Learn More
U.S., EU regulators approve "leadless" ICD from Boston Scientific
The Emblem S-ICD, a "leadless" implantable cardiac defibrillator developed by Boston Scientific, has obtained FDA approval ...Learn More
Maker of diabetes management tool gains $16.5M in Series B financing
Glooko has obtained $16.5 million in a Series B funding round that includes Medtonic as an investor. ...Learn More
Deal to acquire Ivera Medical finalized by 3M
3M has concluded its proposed acquisition of Ivera Medical, a San Diego firm that makes the Curos port connector caps for ...Learn More
Ariz. molecular Dx firm gets $3.9M boost
A private equity offering involving 24 investors has brought in $3.9 million for Scottsdale, Ariz.-based Provista, according ...Learn More
Q4 revenue increases for Calif. molecular Dx firm
CareDx reported a 36% year-over-year revenue increase in the quarter ending Dec. 31. ...Learn More
Positive results reported in 2 studies of Glide Technologies' injection system
The Glide SDI, a solid dose injection system developed by Glide Technologies, demonstrated promising results in two clinical ...Learn More
Test uses single drop of blood to produce point-of-care results
A device that can offer point-of-care results by analyzing one drop of blood has been developed by Cleveland-based Apollo ...Learn More
SpineFrontier records first use of spinal-fusion device in North America
A patient at USMD Hospital at Arlington in Texas has undergone anterior cervical disc fusion using SpineFrontier's Arena-C ...Learn More
Program focuses on using Big Data to advance medical device, drug approval process
The "FDA: Advancing Medical Innovation" initiative was unveiled by the Bipartisan Policy Center to ask Congress to allow the ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Trichomonas Assay, developed by Quidel, has obtained clearance from the FDA. ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
The vitality of a new movement in art must be gauged by the fury it arouses.
Logan Pearsall Smith, ...Learn More


sign up
for a daily briefing on top stories in the medical technology and diagnostics industries, FREE
In the News
Building A Better Valve
By: New York Times | June 2015

The F.D.A. approved the new Edwards valve for high-risk patients; it had been available only in clinical trials. Medtronic also has a new version of its valve that cardiologists expect will soon be approved. 

Learn More
Plasma Makes Wounds Heal Quicker
By: Medical Design Technology | June 2015

Many people suffer from skin disorders. Open wounds are a particularly acute problem, especially among the elderly. PlasmaDerm, a new medical technology solution, uses plasma to facilitate faster healing of wounds.

Learn More
Wearable Device on Your Ear Controls Blood Loss
By: Medical Design Technology | June 2015

While neural stimulation technologies have been around for some time now, it seems the technology is just finally beginning to mature into the form of medical devices that can make a real impact on the lives of those who most desperately need them. 

Learn More
Toddler Walking With New Prosthetic Leg
By: NBC News | June 2015

A toddler undergoes a successful amputation below his left knee and learns to walk with a prosthetic leg.

Learn More


Twitter FeedTwitter
Twitter
@ AdvaMedUpdate