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

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Third-party medtech firm acquired by Globus Medical in $52.9M deal
Globus Medical agreed to pay $52.9 million to buy third-party medtech firm Branch Medical Group. ...Learn More
Sensor maker acquired by Sotera
Reflectance Medical, a company that makes sensors, was purchased by Sotera Wireless, which makes wearable devices, for an ...Learn More
Investor pumps $40M into Illumina's startup accelerator
Illumina Accelerator Boost Capital acquired $40 million in financing from Viking Global Investors to support early-stage ...Learn More
Globus Medical reports Q4 sales growth
Globus Medical generated global sales of $128 million for the fourth quarter, up 11.8% from the same period a year earlier. ...Learn More
St. Jude records first implant of heart failure Dx device in Twin Cities
A patient at Hennepin County Medical Center in Minneapolis was the first in the area to be implanted with St. ...Learn More
U.S., EU regulators clear PCR-based platform from BioFire
The FilmArray 2.0 system, a PCR-based platform developed by BioMerieux unit BioFire Diagnostics, has obtained FDA clearance ...Learn More
Cholangioscopy, pancreatoscopy tool from Boston Scientific cleared by FDA
The SpyGlass DS, a pancreatoscopy and cholangioscopy device from Boston Scientific, has obtained 510(k) clearance from the ...Learn More
BioLytical's HIV test obtains wider FDA approval
BioLytical Laboratories, a Canadian maker of point-of-care rapid diagnostics, received expanded FDA approval for its INSTI ...Learn More
Single-patient use warning required for multi-dose diabetes pens
The FDA announced that multi-dose diabetes pens are now required to carry a warning label indicating single-patient use to ...Learn More
EU approves sample prep system, 2 molecular Dx tests from Meridian
European regulators granted the CE mark to Meridian Bioscience's Illumigene molecular diagnostic tests for Neisseria ...Learn More
Medical Device Complaints, MDRs and Reports
March 18-19Arlington, Va.FDA staff (invited) and experts are coming together to discuss setting up a complaint system, ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Correction
Because of an error in the source story, an item in Thursday's AdvaMed SmartBrief should have said that medtech companies ...Learn More
He who is not every day conquering some fear has not learned the secret of life.
Ralph Waldo Emerson, ...Learn More
AdvaMed applauds bill to protect FDA user fees
A bill introduced by Rep. ...Learn More
For more:
Read the press release with AdvaMed President and CEO Stephen Ubl's complete remarks about the FDA SOS Act to exempt FDA ...Learn More
Sorin to be acquired by Cyberonics in all-stock deal
Medtech firm Cyberonics is planning an all-stock acquisition of Sorin, an Italian medtech firm, to form a new company based ...Learn More
Uroplasty's bladder-control device scores reimbursement win from Cigna
The use of Uroplasty's percutaneous tibial nerve stimulation system to treat overactive bladder and symptoms such as urge ...Learn More
Respiratory virus, HCV genotyping tests drive Q4 revenue growth for GenMark
Carlsbad, Calif.-based firm GenMark generated $9.8 million in revenue in the quarter ending Dec. ...Learn More
Prenatal, miscarriage analysis tests drive Q4 revenue growth for CombiMatrix
CombiMatrix generated $2.2 million in revenue in the quarter ending Dec. ...Learn More
Medtech down south: 4 questions with SEMDA's Jason Rupp
MassDevice.com chats with Jason Rupp, the first full-time executive director for the Southeastern Medical Device Association ...Learn More
Second Sight's prosthetic retina device debuts in France
Implant centers in France have concluded the first commercial implants of the Argus II Retinal Prosthesis System developed ...Learn More
Accelerator welcomes new class of health-tech startups
The accelerator Healthbox Studios has selected nine companies to join its Boston class. ...Learn More
India may hike customs duties on imported medical devices
Officials in India indicated that the government is likely to raise import duties on medical devices by 5%, with the aim of ...Learn More
FDA clears surgical drill from McGinley Orthopaedic Innovations
The IntelliSense Drill, developed by McGinley Orthopaedic Innovations for use in various orthopedic procedures, has obtained ...Learn More
EU approves spine products from Providence Medical Technology
European regulators have granted the CE mark to Providence Medical Technology's DTRAX Bone Screw, DTRAX Cervical Cage and ...Learn More
Molecular Diagnostics and the Changing Landscape
March 12-13Washington, 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
You're going to fall down, but the world doesn't care how many times you fall down, as long as it's one fewer than the number of times you get back up.
Aaron Sorkin, screenwriter and ...Learn More
Myriad's $200M share repurchase program wins board approval
A plan by Myriad Genetics to buy back $200 million of company stock in a repurchase program was approved by the company's ...Learn More
Shareholder vote on Uroplasty/Vision-Sciences merger set for March 30
Shareholders of Vision-Sciences and Uroplasty will vote March 30 on whether to approve an all-stock merger combining the two ...Learn More
Funding round brings in $1.2M for microbial genetics analysis firm
A private financing round brought in $1.2 million for OpGen, a Gaithersburg, Md.-based microbial genetics analysis company. ...Learn More
Instruments, consumables drive Q4 revenue growth for NanoString
NanoString Technologies generated $15.6 million in revenue in the quarter ending Dec. ...Learn More
Higher test volume drives Q4 revenue growth for Foundation Medicine
Foundation Medicine generated $18.7 million in revenue in the quarter ending Dec. ...Learn More
Report: Global market for medical imaging devices poised for growth
A Persistence Market Research report predicts the worldwide medical imaging market will be worth $35 billion by 2020, with a ...Learn More
FTC cracks down on melanoma risk detection apps with unsupported claims
The Federal Trade Commission has taken action against the marketers of the MelApp and Mole Detective mobile applications for ...Learn More
Laser delivery system for Cynosure's dermal repair device cleared by FDA
The 532 nm Laser Delivery System, developed by Cynosure, has obtained clearance from the FDA. ...Learn More
National medtech monitoring system sought by FDA
A Brookings Institution report commissioned by the FDA calls for the establishment of a collaborative national surveillance ...Learn More
FDA labels GE Healthcare's MRI systems recall as Class I
A recall involving GE Healthcare's MRI systems with superconducting magnets has been categorized by the FDA as Class I. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Nothing great in the world has been accomplished without passion.
Georg Wilhelm Friedrich Hegel, ...Learn More
Maker of bladder-control device acquired by Medtronic
Advanced Uro-Solutions, the maker of the Nuro percutaneous tibial nerve stimulator to address bladder-control problems, was ...Learn More
Public offering brings in $9M for molecular Dx firm
Signal Genetics raised $9 million in gross proceeds from its now-closed public offering of about 3.2 million shares. ...Learn More
NIH backs development of microbial molecular Dx test
The NIH has given a $5 million grant to Accelerate Diagnostics and Denver Health Medical Center to fund the development of a ...Learn More
Report: Global preclinical imaging market poised for growth
A Life Science Industry Research report forecasts the worldwide preclinical imaging market will see a 6% compound annual ...Learn More
Industry veteran named executive chairman of OrthAlign's board
Gary Henley was selected to serve as executive chairman of OrthAlign's board. ...Learn More
CMS to cover outpatient use of Medtronic's drug-coated balloon catheter
Procedures using Medtronic's In.Pact Admiral drug-coated balloon catheter in an outpatient setting will receive Medicare ...Learn More
EnteroMedics prepares to launch neurostimulation weight-loss device
The Minnesota firm EnteroMedics is preparing for the commercial release of its Maestro system, a neurostimulation implant to ...Learn More
Switzerland, China sign deal to improve medtech collaboration
An agreement between Switzerland and China seeks to boost cooperation in the medtech field. ...Learn More
Calif. lawmaker urges House oversight committee to investigate superbug outbreak
Rep. ...Learn More
VertiFlex gains FDA panel support for spinal stenosis system
A panel of advisers has endorsed VertiFlex's Superion Interspinous Spacer System for FDA approval. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
The best day of your life is the one on which you decide your life is your own. No apologies or excuses. No one to lean on, rely on, or blame. The gift is yours -- it is an amazing journey -- and you alone are responsible for the quality of it. This is...
Bob Moawad, ...Learn More
Proteomics services firm lowers IPO target to $2.3M, moves closing date
Proteomics International Laboratories moved the closing date for its initial public offering to Friday. ...Learn More
Ivera Medical to be acquired by 3M
Ivera Medical, a San Diego firm that makes the Curos port connector caps for needleless intravenous valves, is being ...Learn More
Maker of anesthetic device reaches deal with distributor
Medline Industries struck a distribution and marketing deal to offer Marathon Pharmaceuticals' Zingo device, a needleless ...Learn More
Report: Minimally invasive surgical tools market to reach $14.13B by 2019
A MarketsandMarkets report predicts the market for minimally invasive surgical instruments will grow to $14.13 billion by ...Learn More
Higher test volume drives Q4 revenue growth for Dx firm LabCorp
Clinical testing services company Laboratory Corp. ...Learn More
Growth in global arthroscopic devices market driven by less-invasive surgeries
A Medical Market Research report found that the worldwide market for arthroscopic devices is growing on the back of greater ...Learn More
Helius begins trial enrollment for brain stimulator device
The first three multiple sclerosis patients have been enrolled by Helius Medical Technologies in a clinical trial of its ...Learn More
Blue Belt hits milestone for robotic surgery device
A partial knee replacement surgery performed recently in Hampton, Va., marked the 1,000th time the Navio Robotic Surgical ...Learn More
23andMe's Bloom syndrome test gets clearance from FDA
23andMe received authorization from the FDA to market its direct-to-consumer genetic test designed to evaluate a person's ...Learn More
Covidien's varicose vein closure system lands FDA nod
The FDA has approved Covidien's VenaSeal, a closure system that treats varicose veins with a medical adhesive that ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
Your only obligation in any lifetime is to be true to yourself.
Richard Bach, ...Learn More
Risk of potentially deadly infection prompts warning over reusable endoscopes
The FDA is warning the medical community about the use of devices designed for complex endoscopy procedures following a ...Learn More
AdvaMed: Indian medtech sector could reach $30B in the next decade
The medtech industry in India could be worth $25 billion to $30 billion over the next 10 years with the proper regulatory ...Learn More
AdvancedCath to be acquired by TE Connectivity in $190M deal
TE Connectivity, a Swiss maker of connectivity and sensor components for medical devices, said it will pay $190 million to ...Learn More
Wound care sales drive Q4 revenue growth for Acelity
Texas-based wound care firm Acelity generated $482.7 million in revenue in the quarter ending Dec. ...Learn More
Pulse oximetry devices drive Q4 sales growth for Masimo
Irvine, Calif.-based patient monitoring firm Masimo generated total sales of $161.8 million in the quarter ending Jan. ...Learn More
EOS reports Swiss installation of imaging system
A private clinic in Lausanne, Switzerland, that is recognized worldwide for orthopedic surgery has installed a unit of EOS ...Learn More
BARDA gives Duke, DxTerity $10.4M grant to develop radiation exposure test
The Biomedical Advanced Research and Development Authority awarded a $10.4 million grant to Duke University for its work ...Learn More
Report: Worldwide 3D printer technologies market to see sustained growth
A Visiongain report predicts the worldwide market for 3D printer technologies will grow to $2.8 billion by 2019 and continue ...Learn More
Calif. program awards $200,000 in funding for health data initiatives
Five programs aimed at advancing research by leveraging aggregated personal health information received a total of $200,000 ...Learn More
CMS to cover outpatient use of Bard's drug-coated balloon catheter
Procedures using C.R. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Your present circumstances don't determine where you can go; they merely determine where you start.
Nido Qubein, businessman and motivational ...Learn More
Medtronic partners with CV health advocates to cut repeat strokes
The American Heart Association and American Stroke Association have partnered with Medtronic in a five-year effort to cut ...Learn More
Molecular Dx firm obtains $12.2M boost
Lineagen has raised $12.2 million in the second tranche of its Series C funding round led by HealthQuest Capital, bringing ...Learn More
Anavex, Amarantus sign deal for use of Alzheimer's biomarker assay
A deal between Amarantus BioScience Holdings and Anavex Life Sciences gives Anavex access to Amarantus' LymPro biomarker ...Learn More
Cook Medical, GPO sign pricing deal
Cook Medical and Premier, a group purchasing organization, have agreed to a tiered pricing arrangement giving GPO members ...Learn More
Sales of C. difficile tests drive Q4 revenue growth for Great Basin
Salt Lake City-based Great Basin generated $445,283 in revenue in the quarter ending Dec. ...Learn More
Biotronik's pacemaker safety claims hold up in MRI studies
Biotronik's ProMRI Evia/Entovis SR-T and DR-T pacemaker systems appear to be safe in certain cases for use with MRI, ...Learn More
CliniCloud unveils remote-care health kit
A new medical kit from CliniCloud includes a smartphone-enabled stethoscope and a wireless, noncontact thermometer that ...Learn More
Medtech innovation challenge retains Smith & Nephew as co-sponsor
The New Venture Competition, organized by the Massachusetts Medical Device Development Center to highlight early-stage ...Learn More
Herpes virus test from Seegene gets FDA clearance
Seegene received clearance from the FDA to market its TOCE technology-based assay for detecting herpes simplex virus types 1 ...Learn More
U.K. regulator names chairman of new medical device expert group
Dr. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, 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
Clarification
Tuesday's SmartQuote, credited to Hannah Szenes, should have identified her as a Hungarian-born paratrooper for the British ...Learn More
[I]f one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with a success unexpected in common hours.
Henry David Thoreau, writer and ...Learn More
Medtronic wins approval for balloon dilatation catheter in Europe
The Euphora Semicompliant Balloon Dilatation Catheter has been launched by Medtronic in Europe, which comes on the heels of ...Learn More
Public offering could bring in about $9M for Signal Genetics
Signal Genetics has priced the more than 3.2 million shares in its public offering at $2.80 each in hopes of obtaining about ...Learn More
Cardiovascular device sales drive Q3 profit growth for Medtronic
Medtronic reported $977 million in earnings in the quarter ending Jan. ...Learn More
NFL awards scouting combine contract to Carestream
The National Football League has struck a deal with Carestream Health for its DRX-1 digital radiography detector. ...Learn More
Analysis predicts global market growth for sports medicine devices
An analysis by ReportsnReports predicts that from 2014 to 2019, the worldwide market for sports medicine devices is ...Learn More
FDA clears versatile orthopedic fixation device from Dallen Medical
The Tensyn Plug, an adjustable orthopedic fixation device from Dallen Medical, obtained 510(k) clearance from the FDA. ...Learn More
FDA panels set review date for Avedro's corneal cross-linking system
The FDA's Ophthalmic Devices Panel and the Dermatologic and Ophthalmic Drugs Advisory Committee will jointly convene Feb. ...Learn More
Drug regulator set to assume control of medical devices in India
A five-day workshop on medical devices was organized by the Central Drugs Standard Control Organization of India as it ...Learn More
EU approves artificial cervical disc from Simplify Medical
Simplify Disc, developed by Simplify Medical with materials that are MRI friendly, has obtained CE mark approval in Europe. ...Learn More
Canada OKs proton therapy system from Mevion Medical
The Mevion S250, a proton therapy device developed by Mevion Medical Systems, was granted a medical device license by Health ...Learn More
Molecular Diagnostics and the Changing Landscape
March 12-13Washington, 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
Blessed are they who see beautiful things in humble places where other people see nothing.
Camille Pissarro, Danish-French ...Learn More
AdvaMed "Innovation Agenda" aims to advance U.S. medtech sector
AdvaMed has unveiled its "Innovation Agenda" to promote the global leadership of the U.S. medtech industry. ...Learn More
For more:
Read the press release about AdvaMed's "Innovation ...Learn More
San Diego-based cancer Dx firm aims to bring in $10M in public offering
Biocept is hoping to secure about $10 million in a public offering of 8 million shares of common stock at $1.25 apiece. ...Learn More
Roche buys genomics and translational oncology firm
Roche has purchased Signature Diagnostics, a translational oncology and genomics firm that specializes in blood plasma, ...Learn More
Firm wins $1.5M grant for HIV/AIDS assay
The NIH has awarded Rheonix a grant worth $1.5 million under the second phase of its Small Business Innovation Research ...Learn More
Industry veteran named interim CEO of JenaValve
Jan Keltjens has been appointed interim chairman and CEO of JenaValve, a maker of transcatheter aortic valve implants. ...Learn More
EU moves deadline to decide on Zimmer-Biomet deal to May 26
The European Commission has pushed back its deadline to decide on whether to approve Zimmer's pending acquisition of ...Learn More
Medtronic's varicose vein device shows positive results in study
A 225-patient study in the British Journal of Surgery showed promising results for ClosureFast, a varicose vein device ...Learn More
Smartphones as effective as other devices in tracking exercise
Researchers at the University of Pennsylvania in Philadelphia found smartphones were as effective as pedometers and ...Learn More
Bone void filler from Nanotherapeutics gets expanded approval from FDA
The FDA has granted Nanotherapeutics expanded approval for its NanoFuse demineralized bone matrix for use with patients' own ...Learn More
Recognized medtech standards updated in U.S.
The FDA has updated its list of recognized standards to include two concerning the use of small connectors for gases 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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Happiness grows at our own firesides, and is not to be picked in strangers' gardens.
Douglas Jerrold, British ...Learn More
Hansen gains FDA nod to expand Sensei surgical robot study
The FDA has allowed Hansen Medical to expand a clinical trial of its robot-assisted surgery platform Sensei in treating ...Learn More
C.R. Bard enters distribution partnership with Boston Scientific
Boston Scientific has struck a limited distribution deal to offer C.R. ...Learn More
Medtech firm gains $1.6M in Series B financing
Pursuit Vascular, a Maple Grove, Minn.-based startup that developed the FDA-cleared ClearGuard HD infection-fighting rod, ...Learn More
Drug-eluting stent technology from Micell debuts in Europe
The MiStent, a sirolimus-eluting stent developed to treat restenosis, is being launched by Micell Technologies in Europe. ...Learn More
Tebu-bio obtains rights to market genome imaging test in Europe
Fort Collins, Colo.-based KromaTiD has struck a distribution deal with French company tebu-bio to help bring KromaTiD's ...Learn More
Aurora Spine's spinal fusion implant debuts in Switzerland
A doctor at Clinique Generale-Beaulieu in Geneva has performed Switzerland's first implantation of the ZIP ULTRA minimally ...Learn More
Neovasc's stent-like device shows promise in refractory angina trial
A study in the New England Journal of Medicine showed promising results for Neovasc's Reducer system, a device implanted in ...Learn More
VitalMedicals to develop more Google Glass-based solutions
VitalMedicals is supporting its effort to design Google Glass solutions for surgeons with $925,000 in recently raised ...Learn More
Study backs use of smartphone ECGs
A study in the Journal of Cardiovascular Electrophysiology found smartphone electrocardiogram monitoring was just as ...Learn More
Anti-stroke device from Silk Road wins FDA nod
The Enroute transcarotid neuroprotection system, a device developed by Silk Road Medical to cut the risk of strokes during ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
You always have two choices: Your commitment versus your fear.
Sammy Davis Jr., American ...Learn More
Insulet to continue deal with Abbott for blood glucose monitor
An exclusive deal between Insulet and Abbott Laboratories has been extended, allowing integration of FreeStyle, Abbott's ...Learn More
Molecular Dx firm could bring in $20M in stock offering
Trovagene is hoping to secure $20 million in a public offering of roughly 4.4 million shares. ...Learn More
Belgian Dx firm aims to bring in $8.5M in public offering
VolitionRx offered 2.475 million shares in a public offering at $3.75 apiece, with net proceeds expected to reach $8.5 ...Learn More
Pfizer boosts generics, biosimilar pipeline with $17B Hospira buy
Pfizer agreed to pay about $17 billion in cash and debt to purchase Hospira, which specializes in developing biosimilars and ...Learn More
China unveils user fees for foreign medtech firms
A draft table issued by the China Food and Drug Administration would charge imported Class III device registrants an initial ...Learn More
MRI-safe pacemaker from Sorin wins approval in Japan
Japanese regulators have given Sorin Group the go-ahead to market its Kora 100 pacemaker in that country. ...Learn More
Medtech incubator upgrades phototherapy system for infantile jaundice
The Brilliance Pro phototherapy system, designed to treat children born with jaundice in developing countries, was launched ...Learn More
Accelerator welcomes new class of health tech startups
The accelerator Blueprint Health has selected several health IT companies to join its seventh class of startups. ...Learn More
Medtronic agrees to $1.25M settlement in billing case
Medtronic reached a $1.25 million settlement to resolve a whistleblower lawsuit in which its Ev3 unit, obtained in the ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Success is how high you bounce when you hit bottom.
George S. Patton, U.S. Army ...Learn More
Medtronic gains FDA OK for brain aneurysm device
The Pipeline Flex, an embolization device that Medtronic acquired in its recent merger with Covidien, has received premarket ...Learn More
Canon teams up with T2 Biosystems on Dx test for Lyme disease
A partnership deal to create a test panel that can quickly diagnose Lyme disease was reached by Canon U.S. ...Learn More
Life sciences, medical segments drive Q1 revenue growth for Becton Dickinson
Becton Dickinson generated $2.05 billion in revenue in its fiscal first quarter, which ended Dec. 31. ...Learn More
New products, infusion systems help fuel Q2 revenue growth for CareFusion
CareFusion posted $1.07 billion in revenue in the quarter ending Dec. 31, a 16% increase over the same period last year. ...Learn More
EU approves noninvasive prenatal assay from Premaitha
The Iona test, developed by Premaitha, has obtained CE mark approval in Europe. ...Learn More
Europe expands approval for Nevro's Senza spinal cord stimulation system
Nevro has earned additional approval from European Union regulators for the use of Senza, an implantable system for spinal ...Learn More
Large joint restoration market in U.S. could eclipse $9B in 2015
An iData Research report has projected that the large joint restoration market in the U.S. ...Learn More
Soft suture anchor introduced by Smith & Nephew
The SUTUREFIX Ultra soft suture anchor, designed for use in shoulder and hip labral repair, has been launched by Smith & ...Learn More
Hamburg resigning as FDA commissioner
Dr. Margaret Hamburg is resigning after nearly six years as FDA commissioner, according to officials. ...Learn More
Lombard's device for larger aneurysms lands FDA approval
The Aorfix Plus stent graft, developed by Lombard Medical Technologies, has obtained premarket approval from the FDA. ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It is good to love many things, for therein lies the true strength, and whosoever loves much performs much, and can accomplish much, and what is done in love is well done.
Vincent van Gogh, Dutch ...Learn More
Drug-eluting balloon from Medtronic debuts in U.S.
The In.Pact Admiral system, a drug-eluting balloon developed by Medtronic as a treatment for patients with peripheral artery ...Learn More
Calif. molecular Dx firm aims to bring in $46.6M in IPO
AutoGenomics said it intends to offer 3.75 million shares in an initial public offering at $11 to $13 apiece, with net ...Learn More
Trice Medical stretches Series B round to $18.1M
Trice Medical raised an additional $6.5 million in a Series B funding round extension led by HealthQuest Capital, bringing ...Learn More
Product sales drive Q4 revenue growth for Affymetrix
Affymetrix generated $93.5 million in total revenue in the quarter ending Dec. ...Learn More
Pediatric device makers win grants from FDA-backed group
Three makers of medical devices intended for children with unmet medical needs will each get a $25,000 grant from the ...Learn More
Accuray reports Mexican installation of TomoTherapy system
Accuray has installed its TomoTherapy system at Fundacion de Cancer de Mama, a treatment center in Mexico City. ...Learn More
Device performs combination immunoassay with help of smartphone
Columbia University researchers have developed an enzyme-linked immunosorbent assay device, which uses a smartphone as its ...Learn More
Cohera's surgical adhesive lands FDA approval
The FDA has granted Cohera Medical approval for TissuGlu, a urethane-based internal adhesive designed for use in ...Learn More
Obama's budget proposal includes more FDA funding, higher user fees
President Barack Obama's fiscal 2016 budget request includes raising the FDA's total budget by 9% to $4.93 billion. ...Learn More
3D breast CT scanner from Koning gains FDA nod
The FDA has granted Koning approval to market its breast CT scanner. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
We often repent of our first thoughts, and scarce ever of our second.
Horace Walpole, British ...Learn More
Medtronic gains FDA OK for pulmonary heart valve
Melody, a transcatheter pulmonary heart valve developed by Medtronic, has obtained premarket approval from the FDA. ...Learn More
Follow-on offering brings in $38.3M for K2M Group
More than 2 million shares have been put up in a follow-on offering at $18.75 per share by K2M Group, bringing in $38.3 ...Learn More
Misonix strikes deal to buy back ultrasonic surgical tool
The Misonix BoneScalpel Ultrasonic Bone Cutting System, which is designed to support osteotomies and en-bloc bone removal ...Learn More
Hypertension device firm gains $1.9M in equity round
An equity round has pulled in $1.9 million for Verve Medical. ...Learn More
Knee and hip arthroplasty device from OrthAlign gets CE mark
The OrthAlign Plus system, developed by OrthAlign, has obtained CE mark approval in Europe. ...Learn More
Proteomics firm gains exclusive rights to market lung test in Canada
A licensing deal has been struck between Caprion, a proteomics company, and Integrated Diagnostics to allow Caprion to ...Learn More
Stryker unveils European base in Amsterdam
The European headquarters of Stryker officially opened last week in Amsterdam as the company looks to increase its Western ...Learn More
Implantable heart device introduced by Boston Scientific
The Extended Longevity implantable cardioverter defibrillator, which can help reduce preventable replacement procedures, has ...Learn More
Smartphone breath analysis tool targets early-disease detection
The SniffPhone project was launched by a Technion-Israel Institute of Technology group to develop a smartphone-based breath ...Learn More
Letter: ACA did not bring surge of new business to medtech companies
Medical technology companies do not enjoy expanded demand for their products because of increased insurance coverage under ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
To be prepared is half the victory.
Miguel de Cervantes, Spanish ...Learn More
Intuitive Surgical's $1B share repurchase program wins board approval
A plan by Intuitive Surgical to buy back up to $1 billion of company stock in a repurchase program funded through ...Learn More
$924M health care fund raised by OrbiMed
New York-based investment group OrbiMed has raised a fund worth $924 million. ...Learn More
Invitae amends IPO target to as high as $92.3M
An initial public offering by Invitae could bring in as much as $92.3 million in net proceeds, according to the company's ...Learn More
Fenner buys maker of bioprocessing devices in $29.9M deal
Fenner Drives has agreed to pay $29.9 million in cash to acquire Charter Medical, a maker of single-use Class I and II ...Learn More
InVivo could bring in about $12M in shares offering
InVivo Therapeutics is hoping to secure $12 million in a direct offering of 8 million shares priced at $1.50 apiece to two ...Learn More
Additional sizes of Medtronic's heart valve gain approval in Europe
European regulators have granted the CE mark to the 29mm and 26mm versions of Medtronic's CoreValve Evolut R System, which ...Learn More
Global market for refurbished devices to reach $9.37B by 2019, report predicts
The worldwide market for refurbished medical equipment and devices could be worth $9.37 billion by 2019 because of the wider ...Learn More
Home care provider signs telehealth deal with Cardiocom
A telehealth partnership deal was secured between Medtronic's Cardiocom business and LHC Group. ...Learn More
HIT vendor designs clinical trial tools
CliniOps has developed several tools that could be used to conduct efficient clinical trials. ...Learn More
Letter: Device tax has "profound negative effect" on U.S. jobs, innovation
The medical device tax has a "profound negative effect" on the nation's jobs and innovation, which is why repealing the tax ...Learn More
Bone tether plate from MedShape cleared by FDA
The FastForward Bone Tether Plate, developed by MedShape for its FastForward Bunion Correction System, has obtained ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
What if you gave someone a gift, and they neglected to thank you for it -- would you be likely to give them another? Life is the same way. In order to attract more of the blessings that life has to offer, you must truly appreciate what you already have.
Ralph Marston, American ...Learn More
Avinger, Entellus raise share offerings in IPOs; Presbia IPO brings in $42M
Avinger has increased the number of shares it is offering in an initial public offering from 4.6 million to 5 million, ...Learn More
Ortho-Clinical Diagnostics signs transfusion diagnostics deal with Quotient
Ortho-Clinical Diagnostics entered into an exclusive agreement with Quotient and will pay $69 million for the rights to ...Learn More
Qualcomm partners with Roche on remote monitoring system
A partnership between Qualcomm Life and Roche will use Qualcomm's 2net Platform and Roche's cloud-based service to improve ...Learn More
Quest Diagnostics reports Q4 sales growth
Quest Diagnostics generated $1.88 billion in sales during the fourth quarter, 7% more than during the same period in 2013 ...Learn More
SpineGuard wins EU patent for guided pedicle screw
SpineGuard has secured a patent in Europe for the smart screw, which is a pedicle screw combined with the company's Dynamic ...Learn More
ISO certification granted to noninvasive prenatal assay from Premaitha
The International Organization for Standardization has granted Premaitha Health ISO certification for the company's Iona ...Learn More
App-sensor system helps track Parkinson's progression
Researchers in Spain are developing the PERFORM system, which uses a smartphone application and a network of sensors to ...Learn More
Study: WhatsApp shows promise in sharing, documenting clinical images
A study in the International Journal of Medical Informatics found that the WhatsApp Messenger shows promise as a tool for ...Learn More
Obama proposes $215M for personalized medicine initiative
President Barack Obama will ask Congress for $215 million to fund his precision medicine initiative, which aims to advance ...Learn More
For more:
Read the statement from AdvaMedDx Executive Director Andrew Fish about the administration's proposal to increase investment ...Learn More
"Right to try" bill introduced in Ill.
A bill that would permit terminally ill patients to get access to unapproved drugs and devices after those products have ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
A contented mind is the greatest blessing a man can enjoy in this world.
Joseph Addison, British ...Learn More
Calif. medtech firm pulls in $19.5M from debt, equity funding
A debt and equity funding round has brought in $19.5 million for USGI Medical. ...Learn More
U.K. molecular Dx firm obtains $20M boost
Atlas Genetics has obtained $20 million in a Series C financing round, which it will use to initiate clinical studies in the ...Learn More
Funding round brings in $2.2M for Biofortuna
A private financing round has brought in $2.2 million for Biofortuna, a molecular diagnostics company. ...Learn More
Israel-based medtech incubator launched by Teva, Philips
Teva Pharmaceuticals and Philips Healthcare have launched Sanara Ventures, a drug and medtech development incubator in ...Learn More
Konica gains exclusive rights to market ultrasound system in Japan
Konica Minolta Medical Imaging has struck a distribution deal with SuperSonic Imagine, a French developer of ultrasound ...Learn More
6-month data show positive results for InspireMD's carotid stent
InspireMD announced positive results from a clinical study evaluating its CGuard Micronet, a mesh-covered carotid stent. ...Learn More
Singapore research agency working on portable dengue test
A field detector test that uses a drop of saliva to diagnose the dengue virus has been developed by researchers at ...Learn More
CF drug-delivery nebulizer from PARI gains FDA nod
The FDA has granted PARI Respiratory Equipment approval to market its eRapid Nebulizer System for delivery of the cystic ...Learn More
Blood test from Venaxis denied 510(k) by FDA
Venaxis said Thursday that its APPY1 rapid blood test failed to obtain 510(k) clearance from the FDA because the agency ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Absorb what is useful. Discard what is not. Add what is uniquely your own.
Bruce Lee, Hong Kong-American martial artist and ...Learn More
AdvaMed: Medical device tax will hurt R&D, cost 195,000 jobs
The 2.3% excise tax on medical devices will cripple medtech companies' R&D efforts and end up killing 195,000 jobs in the ...Learn More
For more:
Read the news release detailing the findings of AdvaMed's survey on the negative impact of the medical device ...Learn More
Roche to pay up to $625M for maker of prenatal tests
Roche said that it will acquire Ariosa Diagnostics, a maker of noninvasive prenatal tests, for up to $625 million. ...Learn More
Vivione buys fellow Dx test maker for up to $15M
Vivione Biosciences, maker of the RAPID-B diagnostic system, agreed to pay as much as $15 million to purchase Trillium ...Learn More
Customer placements drive Q4 revenue growth for Nanosphere
Nanosphere reported $4.6 million in preliminary revenues for the fourth quarter of 2014, a 35% increase from the same period ...Learn More
EU approves unicondylar knee system from Blue Belt
The STRIDE Unicondylar Knee System, designed by Blue Belt Technologies, has obtained CE mark approval in Europe. ...Learn More
Kuwaiti hospitals to get scanners from GE Healthcare
Kuwait's Al Razi Hospital and the Sabah Al Ahmad Urology Center will install GE Healthcare's Optima MR450w MRI scanner, ...Learn More
Tips from the front lines of medtech M&A
Two medtech CEOs, Christopher von Jako, Ph.D., and Edward Kerslake, who sold their companies in 2014 for a combined $500 ...Learn More
Rox's Coupler device shows promise in hypertension study
The Coupler system, a stent-like implant developed by Rox Medical to treat resistant hypertension, reduced the blood ...Learn More
Israeli firm working on low-cost infusion pump
A small, inexpensive and accurate infusion pump is being developed by the Israeli company ToucheMedical for patients with ...Learn More
AEDs to be required to undergo PMA review by FDA
Makers of automated external defibrillators will be required to submit their devices to the FDA's strict premarket approval ...Learn More
FDA clears fracture fixation system from Aesculap
The Aesculap Odontoid Fracture Fixation System, designed to treat fractures affecting small bones as well as small bone ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
All animals, except man, know that the principal business of life is to enjoy it.
Samuel Butler, British ...Learn More
21st Century Cures report proposes priority review for medtech
The FDA is being urged to establish a priority review process for medtech in a report released by the 21st Century Cures ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the discussion draft of potential legislative proposals ...Learn More
Covidien wraps up $30M sale of Stellarex balloon to Spectranetics
Spectranetics has completed its purchase of Covidien's Stellarex drug-eluting balloon for $30 million. ...Learn More
Swiss Dx firm gains $1.1M in additional financing
The second closing of a Series B funding round has pulled in $1.1 million for ProteoMedix. ...Learn More
Siemens Healthcare reorganizes top tier
Hermann Requardt has stepped down as CEO at Siemens Healthcare, while Bernd Montag, the German conglomerate's head of ...Learn More
Agilent scanner approved for in vitro Dx use in China
The SureScan Dx microarray scanner from Agilent Technologies has been given the go-ahead by China's Food and Drug ...Learn More
EU approves a-fib algorithm used with AliveCor's Heart Monitor
European regulators have granted the CE mark to AliveCor's atrial fibrillation-detecting algorithm, making it available for ...Learn More
Study underway for Active's meniscus implant
A patient at the Ohio State University Wexner Medical Center has become the first to be implanted with the NUsurface ...Learn More
Decisio software receives FDA approval
Decisio's solution to improve the workflow of staff in intensive care units and emergency departments has been approved by ...Learn More
St. Jude wins FDA nod for FlexAbility ablation catheter
The FDA has granted St. ...Learn More
FDA grants humanitarian exemption to heart pump from Abiomed
Abiomed secured a humanitarian device exemption approval from the FDA for its Impella RP single-access heart pump to support ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Every artist was first an amateur.
Ralph Waldo Emerson, American ...Learn More
Irish High Court OKs $49.9B Medtronic-Covidien merger
Medtronic's proposed merger with Covidien has obtained approval from the Irish High Court, finalizing the largest merger in ...Learn More
Molecular Dx firm boosts IPO target to $74.3M
AltheaDx has increased the amount it hopes to raise in an initial public offering from $69 million to about $74.3 million. ...Learn More
Neurodiagnostics firm acquired by Natus Medical
Global Neuro-Diagnostics, the maker of home electroencephalography tests, has been purchased by Natus Medical for ...Learn More
GE Healthcare posts strong Q4 sales, orders in U.S.
GE Healthcare reported a 7% increase in sales and a 9% rise in orders in the U.S. ...Learn More
Cervical disc-replacement device from Dymicron gets CE mark
The Triadyme-C Cervical Total Disc Replacement, developed by Dymicron, has obtained CE mark approval in Europe. ...Learn More
Patient enrollment for Sorin's sutureless aortic valve completed
Sorin Group, an Italian maker of cardiovascular devices, has finished enrolling 300 patients in a clinical study of its ...Learn More
Knee-replacement device from OrthAlign used in over 25K procedures
The KneeAlign Total Knee Arthroplasty system, developed by OrthAlign, has been used successfully around the globe in more ...Learn More
FDA OKs device from Bioceptive
The FDA has given medtech startup Bioceptive clearance to market its suction-based device that could replace cervical ...Learn More
Top cardiologist appointed to senior post at FDA
The FDA hired top cardiologist and researcher Dr. ...Learn More
Glucose monitoring app receives marketing approval from FDA
The FDA has approved Dexcom's Share Direct Secondary Displays system for the tracking of blood glucose levels by diabetes ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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We delight in the beauty of the butterfly, but rarely admit the changes it has gone through to achieve that beauty.
Maya Angelou, American ...Learn More
FDA grants HDE status to neurostimulation device from Medtronic
Medtronic secured a humanitarian device exemption approval from the FDA for its Enterra II neurostimulation implant to treat ...Learn More
Calif. insulin pump maker sets IPO's midpoint price at $49M
Asante Solutions said it intends to offer 3.5 million shares in its initial public offering at $13 to $15 per share, making ...Learn More
Firm, clinical reference lab agree to products of conception-testing deal
ReproSource, a clinical reference laboratory, has agreed to offer CombiMatrix's products of conception testing, or ...Learn More
New medtech nomenclature framework unveiled in Russia
Russia's medtech industry regulator, Roszdravnadzor, has issued a new nomenclature classification framework as part of a ...Learn More
Metabolomics project obtains $2.4M boost in Canada
Canada has entered into a $2.4 million investment deal with the University of Alberta and Genome Alberta to develop a ...Learn More
ViewRay taps Itochu to offer radiotherapy product in Japan
ViewRay, a maker of image-guided radiotherapy, has struck a distribution deal with Itochu, a Japanese general trading firm, ...Learn More
FDA gives MED-EL nod on cochlear implant that is MRI-safe
MED-EL said Friday its Synchrony cochlear implant has been cleared by the FDA, and the Durham, N.C.-based medtech firm plans ...Learn More
Nevro closer to FDA approval for pain treatment device
The FDA has issued an approvable letter to Nevro for its Senza system, a device that relieves pain by sending electrical ...Learn More
Health systems, groups call for EHR device ID
A number of health systems, patient safety advocates and medical groups have called on HHS to include provisions in its ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, 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
Every time I paint a portrait I lose a friend.
John Singer Sargent, Italian-born American ...Learn More
CareFusion-Becton Dickinson merger gets shareholder approval
Shareholders on Thursday approved CareFusion's proposed $12 billion merger with Becton Dickinson, which will close once it ...Learn More
BioFire buy drives 2014 revenue growth for BioMerieux
BioMerieux said its total revenue increased to $1.9 billion for the 12 months ending Dec. 31, which was up 7% from 2013. ...Learn More
Surgical solutions, new offerings drive Q1 profit growth for Covidien
Covidien posted a 28.4% rise in profits to $511 million for the quarter ending Dec. 26 on sales of $2.69 billion. ...Learn More
San Diego-based cancer Dx firm to sell 6.3 million shares in IPO
Biocept filed plans Wednesday with the Securities and Exchange Commission to sell about 6.3 million company shares in an ...Learn More
Molecular Dx firm, Norwegian hospital team up in cancer Dx deal
University Hospital Oslo has entered into a cancer diagnostics deal with New Oncology, a German molecular diagnostic ...Learn More
Report: Worldwide MRI market could be worth over $9.2B by 2020
A GlobalData report predicts the worldwide market for MRI systems could grow from about $4.1 billion in 2013 to over $9.2 ...Learn More
U.S. grants 66 patents to Carestream Health in 2014
The U.S. ...Learn More
FDA OKs collagen bone graft from BioStructures
The FDA has given BioStructures, a Newport Beach, Calif., medtech firm, clearance to market its advanced Silhouette ...Learn More
FDA is committed to U.S. trials of medical devices
The FDA has made the first step in its commitment to give U.S. ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Rough diamonds may sometimes be mistaken for worthless pebbles.
Thomas Browne, English ...Learn More
Welch Allyn buys maker of diabetic retinopathy tests
Welch Allyn announced it has purchased Hubble Telemedical, a Knoxville, Tenn.-based maker of remote eye tests for diabetic ...Learn More
Maker of X-ray imaging pill sets IPO's midpoint price at $13.2M
Check-Cap said it is offering 1.2 million shares in its initial public offering at $10 to $12 per share, making the midpoint ...Learn More
Solid sales of surgical devices bolster Blue Belt's performance in 2014
Blue Belt Technologies reported that it sold 33 Navio Surgical System devices globally during its first full year of ...Learn More
Firm, hospital sign deal to study ovarian cancer diagnostic tests
A deal was recently signed by the Belgian company VolitionRx and Singapore General Hospital to start a pilot study that ...Learn More
B. Braun gets exclusive rights to market surgical adhesive in Europe
B. Braun Medical has struck a distribution agreement with Cohera Medical to allow B. ...Learn More
Sygnis taps BioNova to offer product in Spain
Sygnis said it has signed a distribution deal with BioNova Cientifica to help bring its TruePrime Single Cell WGA kit to ...Learn More
An M&A checklist for medical device companies
Medtech companies considering a merger, strategic partnership or investment should consider the following checklist, sourced ...Learn More
Device stimulates nerve to manage Parkinson's symptoms, boost balance
University of Gothenburg scientists in Sweden are testing a device they designed that controls symptoms of Parkinson's ...Learn More
Medtronic launches insulin management system
Medtronic has introduced its MiniMed 640G system meant to bolster insulin management in diabetes patients by suspending and ...Learn More
FDA clears advanced pedicle screw system from K2M
The MESA 2 Deformity Spinal System, a pedicle screw technology designed by K2M for complex spinal pathologies, has obtained ...Learn More
Roche unit pursues FDA OK for lung cancer companion Dx test
An FDA premarket approval application has been filed by Ventana Medical Systems, a unit of Roche, for its ALK (D5F3) CDx ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
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The secret of my influence has always been that it remained secret.
Salvador Dali, Spanish ...Learn More
Calif. PAD catheter maker sets IPO's midpoint price at $59.9M
Avinger said it intends to offer just over 4.6 million shares in its initial public offering at $12 to $14 per share, making ...Learn More
Exactech buys French firm in deal that could reach more than $11M
BlueOrtho SAS, a French computer-assisted surgical technology firm, has been acquired by Exactech, a Gainesville, Fla.-based ...Learn More
Mass. imaging firm sets IPO's midpoint price at $59M
Infraredx said it is offering 4 million shares in its initial public offering at $13 to $15 per share, making the midpoint ...Learn More
Funding round brings in $20M for medical monitoring firm
EarlySense has obtained $20 million in a financing round led by the venture arm of Samsung Electronics. ...Learn More
Public offering of warrants, stock filed by Great Basin
A prospectus has been filed by Great Basin Scientific with the U.S. ...Learn More
Report: Small bone orthopedics market poised for steady growth
A report from Research and Markets projects that the U.S. ...Learn More
Report cites 5% growth for global ultrasound market
A Kalorama Information report says the global market for ultrasound devices is growing at a rate of 5% after posting revenue ...Learn More
U.S. release of Hospira infusion pump planned
Hospira said Tuesday its Plum 360 infusion system with Hospira MedNet has been cleared by the FDA, and the company plans to ...Learn More
Diagnostic monitor from NEC wins FDA nod
The FDA has cleared NEC to market its MultiSync MD210C3 monitor, which comes with an LED display, an integrated front sensor ...Learn More
Integra resolves issues at Puerto Rico facility
The FDA has issued a letter officially clearing Integra Life Sciences' facility in Anasco, Puerto Rico, where the company's ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
Some people drink from the fountain of knowledge. Others just gargle.
Robert Anthony, American business ...Learn More
Cell capture specialist acquired by DNAe
DNAe, a London-based maker of blood-to-result tests for bloodstream conditions, has purchased nanoMR, an Albuquerque, ...Learn More
Aurora Spine pulls in nearly $566K in financing
A private placement of ordinary shares brought Aurora Spine about $565,875 in new funding. ...Learn More
Orthopedics firm gets new CEO
Nick Deeter has been appointed chairman and CEO of Nextremity Solutions, a maker of devices for the foot and ankle market ...Learn More
Dx firm launches medical lab in China
PerkinElmer has announced the opening of the Suzhou PerkinElmer Medical Laboratory in China. ...Learn More
Visualization software company offers dynamic contrast-enhanced imaging solution
A dynamic contrast-enhanced imaging solution that gives users various DCE processing options was recently unveiled by ...Learn More
Fujifilm enhances Synapse PACS' data sharing capability
An Imaging Object Change Management support feature has been added to Fujifilm Medical Systems' Synapse PACS solution. ...Learn More
Heart failure patient survives with aid of artificial heart
A 68-year-old man who had terminal congestive heart failure is recovering at home after receiving an artificial heart from ...Learn More
New FDA guidance seeks to curb cross-contamination from improper use of GI endoscopes
Draft guidance aimed at reducing cross-contamination caused by the inappropriate use of flexible gastrointestinal endoscopes ...Learn More
FDA official sees big promise in MDSAP pilot
The Medical Device Single Audit Program pilot, designed to align audit processes in the U.S., Japan, Canada, Brazil and ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Conformity is the jailer of freedom and the enemy of growth.
John F. Kennedy, 35th U.S. ...Learn More
Report: Medtech M&As rose 18.5% in 2014
A GlobalData analysis showed that the medtech sector reported 96 mergers and acquisitions in 2014, which is 18.5% more than ...Learn More
Minn. device firm sets IPO's midpoint price at $70M
Entellus Medical said it is offering 4.375 million shares in its initial public offering at $15 to $17 per share, making the ...Learn More
IPO could pull in as much as $69M for Bellerophon Therapeutics
Bellerophon Therapeutics has filed an initial public offering in hopes of obtaining up to $69 million. ...Learn More
EU approves sirolimus-eluting stent from Eurocor
European regulators have granted the CE mark to Eurocor's E-Magic Plus Sirolimus Eluting Coronary Stent System. ...Learn More
Ultra-thin skin patch could eliminate need for glucose finger prick
Researchers at the University of California, San Diego, have created an ultra-thin, flexible skin patch designed to evaluate ...Learn More
Signostics' handheld bladder scanner cleared by FDA
The FDA has given Signostics 510(k) clearance to market the portable SignosRT Bladder scanner. ...Learn More
FDA clears single-use spine system from ECA Medical
The Intelligent Implant Systems Revolution Spinal System, a single-procedure instrument kit developed by ECA Medical ...Learn More
Joint venture to give researchers access to eICU patient data
Medical researchers will have access to data on more than 100,000 patients in Royal Philips' Hospital to Home eICU ...Learn More
Draft guidance addresses FDA's policy on wellness products
Draft guidance from the FDA aims to clarify its policy on distinguishing low-risk general wellness products from medical ...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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
It is good to have an end to journey towards, but it is the journey that matters, in the end.
Ursula Le Guin, American ...Learn More
Maker of corneal implant sets IPO's midpoint price at $50.4M
Presbia said it is offering 4.2 million shares in its initial public offering at $11 to $13 per share, making the midpoint ...Learn More
Investments in Minn. medtech reached $430M in 2014
A LifeScience Alley report showed that investment in Minnesota's medtech sector reached a six-year high in 2014 on the back ...Learn More
Loan, funding round bring in $30M for Obalon
Obalon Therapeutics, a Carlsbad, Calif.-based firm, has pulled in $30 million to develop the Obalon balloon, an ingestible ...Learn More
St. Jude posts slightly higher Q4 sales amid setbacks
St. ...Learn More
Molecular Dx firm, hospital team up in cancer genomics deal
Foundation Medicine has agreed to work with Avera McKennan Hospital to carry out clinical trials that center on personalized ...Learn More
B. Braun gains exclusive rights to market pain device in U.K.
GenomeDx scores reimbursement win for prostate cancer test
Medicare benefits administrator Palmetto GBA has issued a policy to cover GenomeDx Biosciences' Decipher prostate cancer ...Learn More
Report lists emerging technologies for hospitals in 2015
Artificial pancreas device technologies, anti-obesity devices and 3D printing are among the emerging health technologies ...Learn More
U.S. patent issued to Silver Bullet's antimicrobial metal ion technology
The U.S. ...Learn More
Lawmakers work on bipartisan legislation to accelerate cures
Rep. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
Learn the rules like a pro, so you can break them like an artist.
Pablo Picasso, Spanish ...Learn More
EnteroMedics' anti-obesity device gains FDA approval
The FDA has granted EnteroMedics approval for its Maestro Rechargeable System to address severe obesity. ...Learn More
German Dx firm gains rights to MDxHealth's PCR system
Oncgnostics, a Germany-based molecular diagnostics company, has entered into a licensing deal with MDxHealth for undisclosed ...Learn More
2 groups team up on clinical trial services for cardiovascular device firms
The Cardiovascular Research Foundation has agreed to work with Novella Clinical to provide makers of cardiovascular devices ...Learn More
EU, Australia approve biologic bone graft from Cerapedics
A biologic bone graft developed by Cerapedics has obtained Therapeutic Goods Administration listing in Australia and CE mark ...Learn More
Stryker looks to grow through acquisitions, expand European footprint
Stryker has set its focus on bolstering its market share in Europe and is looking to achieve that growth through ...Learn More
Gov. Deval Patrick's life sciences legacy in Massachusetts
MassDevice.com looks at the legacy of former Massachusetts Gov. Deval Patrick when it comes to medical devices and biotech. ...Learn More
Firm gains FDA clearance for spinal fixation device
Valorem Surgical has received FDA clearance for MaxiMIS, a spinal fixation system that is minimally invasive. ...Learn More
ExThera joins team developing sepsis treatment device
ExThera Medical will work with Battelle and NxStage Medical in a project supported by the Pentagon's Defense Advanced ...Learn More
Patient awaiting heart transplant can go home thanks to portable device
Heart transplant candidate Stan Larkin was able to be discharged from the University of Michigan Frankel Cardiovascular ...Learn More
InVivo gets FDA nod to reopen enrollment for spinal injury trial
The FDA has given InVivo Therapeutics the go-ahead to resume enrollment of patients with acute spinal cord injuries in a ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
You must not lose faith in humanity. Humanity is like an ocean; if a few drops of the ocean are dirty, the ocean does not become dirty.
Mahatma Gandhi, Indian independence movement ...Learn More
Hatch files Senate bill to repeal medical device tax
The Medical Device Access & Innovation Protection Act, a bipartisan bill to repeal the 2.3% excise tax on medical devices, ...Learn More
For more:
Read the statement from AdvaMed, the Medical Imaging & Technology Alliance (MITA) and the Medical Device Manufacturers ...Learn More
Medtech firm gains $16.85M in Series B financing
Vascular Dynamics has obtained $16.85 million in a Series B funding round led by HBM Healthcare Investments. ...Learn More
Ultrasound market in U.S. could eclipse $2B by 2020
An iData Research report found that the ultrasound equipment market in the U.S. ...Learn More
CEO: Boston Scientific eyeing higher sales in BRIC markets by 2017
Boston Scientific obtained about 10% of its overall sales for the quarter ending Sept. ...Learn More
Report predicts global angiography market to reach $27.7B
A MarketsandMarkets report found that the global market for angiography devices is poised to hit $27.7 billion at a compound ...Learn More
Oracle partners with Proteus on data collection using ingestible sensors
A partnership between Proteus Digital Health and Oracle will allow researchers to monitor medication adherence of patients ...Learn More
Colorectal cancer NGS panel introduced by Vela
The Sentosa SQ Colorectal Cancer panel, a next-generation sequencing assay approved by European regulators, is being ...Learn More
Medical center, Advanced Biological Labs partner on HIV drug resistance test
Advanced Biological Laboratories is partnering with University Hospitals Case Medical Center to design and support Deepgen ...Learn More
IDE application for BiO2's pulmonary embolism catheter cleared by FDA
The FDA has approved the investigational device exemption application filed by BiO2 Medical, a San Antonio-based medtech ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
No man is a failure who is enjoying life.
William Feather, American ...Learn More
Roche to get majority stake in Foundation Medicine under $1.18B deal
Roche Holding could spend up to $1.18 billion under plans to acquire a majority stake in Foundation Medicine, a molecular ...Learn More
Conclusion of Medtronic-Covidien deal could come as early as Jan. 29
Ireland's High Court is set to meet Jan. 26 for a hearing on the $43 billion Medtronic-Covidien merger deal. ...Learn More
Maker of genetic tests eyes $86M in IPO
Invitae, a San Francisco-based maker of genetic tests, has filed an initial public offering in hopes of obtaining $86 ...Learn More
Biodesix stretches Series E round to $27M
Biodesix has obtained an additional $12 million in Series E financing from existing investors, bringing its total for that ...Learn More
PACS developer signs imaging system deal with radiology group
A five-year contract was recently signed by Zwanger-Pesiri Radiology with Visage Imaging, a developer of PACS and advanced ...Learn More
Diaxonhit, hospital partner to process molecular Dx tests in Europe
A service sublicensing deal has been signed by Diaxonhit, the European distributor of CareDx's AlloMap tests, with ...Learn More
EU approves lung cancer liquid biopsy test from Qiagen
European regulators have given the CE mark to Qiagen's therascreen EGFR RGQ Plasma PCR kit. ...Learn More
Radiation-free breast scanner introduced by TiaLinx
TiaLinx is launching the AR60-A, a non-contact breast tissue screening device that can detect and single out abnormal cell ...Learn More
FDA expands clearance for Intact Medical's breast-lesion procedure
The Intact System, a minimally invasive procedure developed by Framingham, Mass.-based Intact Medical, has obtained 510(k) ...Learn More
FDA clears Tandem's t:flex Insulin Pump
The FDA has cleared Tandem Diabetes Care to market its t:flex Insulin Pump, which has the largest insulin reservoir capacity ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
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It is a fine seasoning for joy to think of those we love.
Moliere, French ...Learn More
Fountain Healthcare to invest $127.5M fund in medtech, other health fields
Irish venture capital firm Fountain Healthcare Partners has closed a $127.5 million fund that it plans to invest in medical ...Learn More
Qiagen buys enzymes provider, signs deal with ArcherDX
The enzyme solutions division of Enzymatics has been purchased by Qiagen for an undisclosed sum. ...Learn More
Medtech raises $50M in venture capital for additional programs
Boston-based PureTech, a life science research firm involved in medical devices, digital health and biotech, has received ...Learn More
Firm gets $8M boost to commercialize products, expand portfolio
DiaCarta, a Hayward, Calif-based developer of in vitro diagnostic tests, has obtained $8 million in a Series A funding round ...Learn More
EU approves drug-eluting balloon from Covidien
Covidien's Stellarex drug-eluting balloon has received market clearance from European regulators as a treatment for ...Learn More
Roche gains approval for blood, plasma donation test
Roche has received FDA approval for the new version of its cobas TaqScreen MPX Test. ...Learn More
FDA approves Viztek's Exa PACS
The FDA has given 510(k) clearance to Viztek for its Exa PACS, which is compatible with any operating system or device being ...Learn More
Researchers create monitoring software for status epilepticus
Boston Children's Hospital researchers developed intelligent software to use as an ICU monitoring system for patients with ...Learn More
FDA device center publishes guidance goals for 2015
The FDA's Center for Devices and Radiological Health will focus this year on giving the medical device industry more data on ...Learn More
PorOsteon's metal cervical cage cleared by FDA
The FDA has granted PorOsteon 510(k) clearance for its Phusion Metal Cervical Cage to address cervical disc disease. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
The most important thing in communication is hearing what isn't said.
Peter Drucker, Austrian-American writer and management ...Learn More
Integrity pulls in $1.6M for noninvasive blood glucose monitor
Blood glucose device maker Integrity Applications obtained $1.6 million in additional funding on Dec. ...Learn More
Lung sealant maker acquired by Pulmonx
Pulmonx, a maker of lung valve implants based in Switzerland and California, announced its acquisition of ...Learn More
2 molecular diagnostic firms to partner on lung cancer test
A partnership deal to create a test to diagnose the mutation and expression of the ALK gene, a target for non-small cell ...Learn More
Nephros appoints acting president, CEO, CFO
Paul Mieyal has been appointed acting president, acting CEO and acting chief financial officer of Nephros, a maker of ...Learn More
EU approves BRACAnalysis CDx assay from Myriad
European regulators have granted Myriad Genetics approval for its Tumor BRACAnalysis CDx assay, which is a companion ...Learn More
India plans update of medtech regulations
The Central Drugs Standard Control Organization of India plans to introduce a bill to revise medical device regulations and ...Learn More
Medtronic begins trial for cryoablation balloon in Europe
A European clinical study launched by Medtronic aims to examine the use of its cryoablation balloon, Arctic Front Advance, ...Learn More
St. Jude starts ventricular tachycardia study in U.S.
St. ...Learn More
Researchers develop new prostate cancer imaging protocol
Researchers at the University of California, San Diego, have created a new imaging technique known as restriction spectrum ...Learn More
U.S. lifts ban on imported pumps from Hospira
The FDA has lifted import restrictions on infusion pumps produced by Hospira in Costa Rica. ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Peace cannot be kept by force; it can only be achieved by understanding.
Albert Einstein, German-American theoretical ...Learn More
Proposal to repeal medical device tax introduced in the House
A bipartisan bill to repeal the 2.3% excise tax on medical devices was introduced in the U.S. ...Learn More
For more:
Read the press release from AdvaMed outlining its support, along with the MITA and MDMA, for the medical device tax repeal. ...Learn More
CardioFocus pulls in $31.7M in equity funding
A financing round has brought in $31.7 million for CardioFocus, which hopes to bring in $33.2 million overall. ...Learn More
Report predicts global X-ray market to reach $9.8B by 2018
A Transparency Market Research report found that the global X-ray market is poised to hit $9.8 billion by 2018 on the back ...Learn More
Cleveland HeartLab purchases heart disease risk assessment tool
The MIRISK test, which is designed to assess a person's likelihood of suffering a heart attack within five years, was ...Learn More
Chairman of Boston Scientific announces plan to retire in 2017
Peter Nicholas disclosed his plan to step down as chairman of Boston Scientific in 2017. ...Learn More
Shockwave wins approval for PAD device in Europe
A balloon catheter developed by Shockwave Medical for the treatment of peripheral arterial disease has obtained CE mark ...Learn More
ReShape Medical's Duo balloon system looks to curb obesity
A Q&A with ReShape Medical CEO Richard Thompson on the company's cash pay procedure and how it can make a dent in obese ...Learn More
Trial underway for Medtronic's antibacterial cardiac mesh pouch
Medtronic has begun a clinical study of its Tyrx envelope, which releases minocycline and rifampin to reduce infections ...Learn More
Walgreens teams up with Qualcomm to link personal health data to medical devices
Walgreens and Qualcomm Life will partner to wirelessly link medical devices with personal health data. ...Learn More
Wireless fertility sensor wins mHealth competition
Prima Temp's wireless fertility sensor, called the BLOOM ring, won the top prize at the mHealth Summit 2014 Venture+ Forum ...Learn More
Alere's nucleic acid-based flu test gains FDA waiver
Alere received a CLIA waiver from the FDA for the expanded use of its Alere i Influenza A&B flu diagnostic assay. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Things don't have to change the world to be important.
Steve Jobs, American ...Learn More
Medtronic-Covidien merger gets shareholder approval
Shareholders on Tuesday approved Medtronic's proposed $43 billion merger with Covidien, which is set to close by early next ...Learn More
CareFusion, Becton Dickinson reach settlement deal on merger lawsuits
CareFusion and Becton Dickinson have agreed to settle lawsuits that shareholders filed in Delaware and California state ...Learn More
Molecular Dx firm Diagnovus acquired by Tenn.-based toxicology lab
Nashville, Tenn.-based toxicology lab Aegis Sciences has purchased Diagnovus, a molecular diagnostics firm, for an ...Learn More
Series C round pulls in $12M for GlySens' implantable glucose monitor
GlySens has obtained $12 million in a Series C financing round, which the company will use to complete development of its ...Learn More
Spine, bone-healing unit drives sales growth for Biomet in November quarter
Orthopedic device maker Biomet posted higher earnings for the quarter ended Nov. ...Learn More
EU approves portable hemodialysis system from Quanta
European regulators have granted Quanta Fluid Solutions CE mark approval for its SC+ portable, cartridge-based hemodialysis ...Learn More
High accuracy achieved by CAD for virtual CTC images in study
A study by Massachusetts General Hospital found that virtual monochromatic dual-energy CT colonography could be accurately ...Learn More
Bladder scanner from dBMEDx wins FDA nod
The FDA has cleared dBMEDx, an ultrasound technology developer, to market its BBS Revolution bladder scanner. ...Learn More
Cohera closer to FDA approval for surgical adhesive
The FDA has issued an approvable letter to Cohera Medical for its TissuGlu, a surgical sealant for use in abdominoplasty and ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It may be necessary temporarily to accept a lesser evil, but one must never label a necessary evil as good.
Margaret Mead, American cultural ...Learn More
Medical imaging technology firm acquired by Lexmark in $37M deal
Lexmark International has agreed to pay $37 million to acquire Claron Technology, a maker of image viewing, distribution, ...Learn More
U.S. antitrust waiting period for Tornier-Wright deal extended until Jan. 28
Dutch medical device company Tornier has resubmitted its antitrust registration in the U.S., which extends until Jan. ...Learn More
Canada-based hospital bed maker acquired by Stryker
CHG Hospital Beds of Canada, a manufacturer of low-height beds to cut the risk of patient falls, has been purchased by ...Learn More
Spine surgery systems drive Q4 revenue growth for Mazor Robotics
Mazor Robotics expects to report revenue of $5.7 million for the fourth quarter of 2014 after selling six Renaissance ...Learn More
Rapid point-of-care test measures blood markers of concussion
BioDirection, an Arizona-based startup that recently raised $1.6 million, is developing a point-of-care test that uses a ...Learn More
RF imaging unit for breast cancer introduced by TiaLinx
The portable radiofrequency imaging system AR60-A has been unveiled by TiaLinx, a radiometry sensor developer, to diagnose ...Learn More
Globus Medical signs supply deal with U.K. collagen powder provider
A contract has been signed by Collagen Solutions to supply Globus Medical, a maker of musculoskeletal implants, with fibrous ...Learn More
Medtronic gains FDA approval for drug-eluting balloon
The FDA has given Medtronic approval to market its drug-eluting balloon as a treatment for patients with peripheral artery ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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Art is either plagiarism or revolution.
Paul Gauguin, French ...Learn More
Shareholder vote on Medtronic-Covidien merger set for Tuesday
Covidien and Medtronic shareholders will vote Tuesday on whether to approve a deal combining the two firms under a single ...Learn More
Medtech raises nearly $350M in venture capital at year's end
The volume and value of venture financing deals in the medical device sector improved in December. ...Learn More
EU OKs acoustic heart-disease detector from Aum Cardiovascular
European regulators have given Aum Cardiovascular the go-ahead to market its CADence System, designed to diagnose blockages ...Learn More
India hopes to attract foreign investment in medtech firms with new rule
American Chamber of Commerce in India Executive Director Ajay Singha said that the government's move to authorize as much as ...Learn More
Study finds lower recall rates using tomo-digital mammography combo
A study in the journal Radiology found that recall rates were lower by 37% when tomosynthesis was added to digital ...Learn More
Pain-relieving device from NeuroMetrix poised for launch
The Quell pain-relieving neurostimulator will be released this week by NeuroMetrix at the 2015 International Consumer ...Learn More
Heart failure patient survives with aid of experimental partition device
Tom Desmond of Buffalo, N.Y., had three heart attacks and was diagnosed with congestive heart failure when he was chosen to ...Learn More
FDA approves Aethlon's Hemopurifier for Ebola trial
The FDA has given Aethlon Medical the green light to test its Hemopurifier, an experimental device designed to reduce Ebola ...Learn More
SCID test for infants gets FDA nod
The EnLite Neonatal TREC Kit was approved by the FDA to screen newborns for severe combined immunodeficiency, a set of ...Learn More
Medtech innovation, industry suffer under medical device tax
Now is the time to end the medical device tax and support rather than stifle innovation, writes Tom Fogarty, founder of the ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, 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
Let us not look back in anger, nor forward in fear, but around in awareness.
James Thurber, American ...Learn More
Calif. PAD catheter maker targets $69M in IPO
Avinger filed plans this week with the Securities and Exchange Commission for an initial public offering and is hoping to ...Learn More
IPO could bring in up to $60M for HTG Molecular Diagnostics
Tucson, Ariz.-based HTG Molecular Diagnostics is hoping to secure as much as $60 million in an initial public offering. ...Learn More
Report predicts $5B boost in U.S. neurological device market
The U.S. ...Learn More
Avant Diagnostics acquired by American Liberty Petroleum
Avant Diagnostics, an Arizona-based medical diagnostics firm, has been purchased by American Liberty Petroleum. ...Learn More
Israeli medtech firm announces plans for ADR registration
CollPlant Holdings, a medical device firm based in Israel, aims to secure first-level American Depository Receipts. ...Learn More
Survey examines interest in using wearables to monitor health
An A&D Medical survey says a majority of Americans are interested in using wearable systems to track their health and ...Learn More
Medtech devices that made headlines in 2014
In 2014, the medical device sector used cutting-edge technology to produce some breakthrough devices. ...Learn More
NeuroMetrix to launch new pain relief device
NeuroMetrix plans to launch Quell, its noninvasive neurostimulation device for relieving chronic pain, at a consumer ...Learn More
Availability of rapid syphilis test widened by FDA
A waiver was granted by the FDA extending the use of the Syphilis Health Check rapid test to other health care settings ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The soul that is within me no man can degrade.
Frederick Douglass, American social reformer and ...Learn More
Warrant reset agreements pump $903K into Pressure BioSciences
Pressure BioSciences has obtained $903,000 after completing a series of warrant reset agreements that repriced the common ...Learn More
Debt, equity funding round pulls in $6M for BiOM
A debt and equity funding round has brought in $6 million for BiOM, a personal bionics developer based in Bedford, Mass., ...Learn More
U.S. Navy approves Carestream imaging, communication systems
Imaging systems maker Carestream Health has won the U.S. ...Learn More
Echo Therapeutics announces new CFO
Alan Schoenbart has been appointed chief financial officer of Echo Therapeutics, maker of the Symphony continuous glucose ...Learn More
Australian molecular Dx firm obtains $211K
Genetic Technologies, a Melbourne, Australia-based molecular diagnostics firm, raised $211,000 through a share purchase ...Learn More
FDA OKs Olympus' endoscopic light imaging system for cystoscopy
Olympus' Narrow Band Imaging technology has been cleared by the FDA for assessing nonmuscle-invasive bladder cancer in ...Learn More
GOP lawmakers to prioritize medical device tax repeal
Repeal of the 2.3% medical device tax will be one of the main priorities of the Republican-led Congress in 2015, said Rep. ...Learn More
IDE application for cytokine absorber submitted by CytoSorbents
An investigational device exemption application has been filed with the FDA by CytoSorbents to begin human trials of the ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
SmartBrief will not publish Thursday
In observance of New Year's Day, SmartBrief will not publish Thursday. Publication will resume ...Learn More
Flowers grow out of dark moments.
Corita Kent, American nun and ...Learn More
LabCorp revises revolving credit facility, obtains $1B loan
Bank of America, acting as administrative agent for a group of lenders, has agreed to grant the Laboratory Corp. ...Learn More
Alzheimer's Dx startup receives $1M boost
Palo Alto, Calif.-based NeuroTrack Technologies has secured $1 million in debt, a regulatory filing shows. ...Learn More
Response Genetics faces possible Nasdaq delisting
Response Genetics, a molecular diagnostics company operating in Los Angeles, stands to be delisted from the Nasdaq Capital ...Learn More
Covidien reaches settlement deal with shareholders
Covidien has agreed to a memorandum of understanding with some of its shareholders to resolve a combination of three ...Learn More
Smith & Nephew's wound therapy system shows promise in trial
A study presented at the Sixth European Symposium of Aesthetic Surgery of the Breast in Milan, Italy, showed promising ...Learn More
FDA authorizes emergency use of Roche's Ebola test
Roche announced that the FDA has authorized the emergency use of its LightMix Ebola Zaire rRT-PCR Test in certain U.S. ...Learn More
Heart Sync's defibrillator electrode recall labeled Class I by FDA
A recall initiated by Michigan firm Heart Sync on Nov. ...Learn More
Ubl sets record straight on 510(k) process
In a letter to the editor, AdvaMed President Stephen Ubl emphasizes that the FDA's 510(k) process for clearing low- and ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
I can accept failure; everyone fails at something. But I can't accept not trying.
Michael Jordan, American professional basketball ...Learn More
N.C. company to buy Va. maker of drug monitoring, Dx products
Alternative Energy & Environmental Solutions, headquartered in Chapel Hill, N.C., has signed a letter of intent to purchase ...Learn More
New Era Orthopaedics signs manufacturing deal with Micron Products
Micron Products has struck an exclusive five-year manufacturing contract with New Era Orthopaedics for its designs for ...Learn More
Alpinion Medical Systems launches first South Korean HIFU system
Alpinion Medical Systems has developed the first High Intensity Focused Ultrasound imaging apparatus in South Korea. ...Learn More
Sleep apnea, heart diagnostics maker seeks partners in new markets
Itamar Medical, a Caesarea, Israel-based firm specializing in sleep apnea and heart diagnostics products, is looking for ...Learn More
Study shows promising results for rheumatoid arthritis device
The University of Amsterdam reported promising results after conducting a small-scale study on an implantable medical device ...Learn More
Researchers warn about safety, accuracy of blood pressure management apps
A study in the Journal of the American Society of Hypertension found that only 3% of 107 blood pressure management ...Learn More
Use of customized implants employing 3D technology increases
Conformis, a Massachusetts company that uses 3D technology, created a knee replacement implant that was used in a successful ...Learn More
Experts create, patent device to speed fracture recovery
Two Tulsa, Okla.-based surgeons have developed and patented a device called the Norris Surgical fracture plate, which is ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, 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
Sometimes by losing a battle you find a new way to win the war.
Donald Trump, American ...Learn More
IPO could bring in as much as $69M for Entellus
Entellus Medical said it will launch an initial public offering in hopes of obtaining as much as $69 million. ...Learn More
Investors, financing deal pump $10M into Mass. genetic testing company
A private financing round has brought in $5 million for Interleukin Genetics, developer of the PerioPredict genetic test for ...Learn More
Image-guided therapy company gets $3M boost
IMRIS has received an estimated $3 million in a private placement funding round. ...Learn More
Calif. molecular Dx firm drops plans to go public
CardioDx, the Palo Alto, Calif.-based molecular diagnostics firm behind the Corus CAD test, has filed to withdraw its ...Learn More
Machine Solutions boosts business with Steeger USA acquisition
Arizona-based Machine Solutions, a unit of Forsyth Capital Investors, has closed its purchase of Steeger USA under ...Learn More
Reproductive Health Science, Tani Medikal agree to distribution deal
Turkish company Tani Medikal has struck a three-year distribution deal with Reproductive Health Science, a biotech firm ...Learn More
Cerevast Therapeutics enrolling patients for ClotBust ER trial
Redmond, Wash.-based Cerevast Therapeutics continues to enroll patients in its international trial for ClotBust ER, a ...Learn More
Novocure device may stem spread of brain cancer
The Novocure cap, an experimental medical device that emits electronic signals targeting brain cancer cells to prevent ...Learn More
Alternative to 3D printing precisely places microtissues
Researchers in Rhode Island are developing technology that precisely places individual microtissues, an approach that could ...Learn More
India lifts approval requirement for purchase of device companies
The Indian government has removed the approval requirement for foreign companies seeking to fully purchase existing medical ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's fine to celebrate success, but it is more important to heed the lessons of failure.
Bill Gates, American businessman and ...Learn More
AltheaDx aims to bring in $69M from IPO
AltheaDx, a molecular diagnostics firm in San Diego, plans to launch an initial public offering to raise up to $69 million. ...Learn More
IPO could pull in up to $55M for Infraredx
Infraredx, a Burlington, Mass.-based intravascular imaging firm, looks to obtain $55 million in an initial public offering. ...Learn More
Calif. medical device firm targets $14M in IPO
San Diego-based BeneChill said in a regulatory filing that it plans to launch an initial public offering in hopes of raising ...Learn More
Abbott closes $250M acquisition of Topera
Abbott Laboratories wrapped up its acquisition of Topera, a California-based firm specializing in medical devices for atrial ...Learn More
Siemens Healthcare denies plans to go public
Siemens Healthcare will not be filing to launch an initial public offering, although there are plans for the health care ...Learn More
Positive results reported in study of Medtronic's drug-eluting balloon
Medtronic's In.Pact Admiral drug-eluting balloon demonstrated superior results compared with a standard angioplasty balloon, ...Learn More
Osiris Therapeutics enters partnership with Stryker
Osiris Therapeutics, developer of the OvationOS viable bone matrix tissue form, has struck an exclusive deal with Stryker. ...Learn More
AMIC files de novo submission to reclassify brachytherapy device
Advanced Medical Isotope has filed a de novo submission with the FDA requesting to reclassify its yttrium-90 RadioGel ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
SmartBrief will not publish Thursday
In observance of Christmas, SmartBrief will not publish Thursday. Publication will resume ...Learn More
You've got to go out on a limb sometimes because that's where the fruit is.
Will Rogers, American performer and ...Learn More
Modular insulin pump maker aims for $45M in IPO
Sunnyvale, Calif.-based Asante Solutions seeks to obtain $45 million in an initial public offering. ...Learn More
Genomic testing services firm gets $16.8M boost
A financing round has brought in $16.8 million for Kew Group, a genomic testing services company in Cambridge, Mass. ...Learn More
Series B round pulls in $12M for ImmusanT
ImmusanT has received $12 million from Vatera Healthcare Partners in a Series B funding round. ...Learn More
Uroplasty reaches merger deal with Vision-Sciences
Uroplasty and Vision-Sciences have agreed to merge in the first half of 2015. ...Learn More
Zoll Medical to purchase circulatory support device maker
Zoll Medical has agreed to pay an undisclosed sum to acquire Roseville, Minn.-based Advanced Circulatory Systems, which ...Learn More
EU approves Cobas CMV assay from Roche
European regulators have granted Roche CE mark approval for its Cobas CMV assay, which keeps track of the viral load in ...Learn More
CAPRI Corpectomy Cage System from K2M debuts in Italy
A doctor at Rizzoli Hospital in Bologna, Italy, has completed the first surgical procedure that used K2M's CAPRI Corpectomy ...Learn More
Overnight use of NxStage's home dialysis system gets FDA approval
NxStage Medical's at-home hemodialysis system has been cleared by the FDA for use at night while patients sleep. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
In the time we have it is surely our duty to do all the good we can to all the people we can in all the ways we can.
William Barclay, Scottish ...Learn More
Pentagon taps Meridian Medical for $129.5M auto-injector deal
The Department of Defense has awarded Maryland-based Meridian Medical Technologies a contract worth $129.5 million. ...Learn More
Roche purchases Calif. genomic data software firm
Bina Technologies, a Redwood City, Calif.-based informatics company, has been acquired by Roche for undisclosed terms. ...Learn More
Veracyte, Silicon Valley Bank agree on revised loan agreement
Veracyte, which develops gene expression-based diagnostic tests, has revised its loan agreement with Silicon Valley Bank. ...Learn More
Baxter to expand facility in Ark.
Baxter International is adding 25,000 square feet of space to its 550,000-square-foot medtech facility in Mountain Home, ...Learn More
Trauma fixation device market in Asia expected to hit $1.2B by 2018
The Asian trauma fixation device market is poised to hit $1.2 billion by 2018, which represents a 6.5% compound annual ...Learn More
TransEnterix's SurgiBot system completes 4 surgical procedures
TransEnterix reported that surgeons have used SurgiBot, its robotic surgery system, to complete four preclinical surgery ...Learn More
Myriad gets FDA nod for BRACAnalysis CDx diagnostic assay
The FDA has granted Myriad approval to market its BRACAnalysis CDx assay as a companion diagnostic for AstraZeneca's ...Learn More
Bioactive bone scaffolds from Bio2 Technologies win FDA approval
Bio2 Technologies received 510(k) clearance from the FDA to market its CLM high-tech bioactive scaffold wedges. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Great things are not done by impulse, but by a series of small things brought together.
Vincent van Gogh, Dutch ...Learn More
Investors pump $35M into Calif. genomic Dx firm
Redwood City, Calif.-based CardioDx has raised $35 million from a funding round that included Alberta Investment Management ...Learn More
Knee implant device startup raises over $7.8M in funding
Cotera, a startup developing knee implant devices for treating osteoarthritis, has secured over $7.8 million through an ...Learn More
Prices of drug-eluting stents dropped 6% in 2014, index shows
The Modern Healthcare/ECRI Institute Technology Price Index reported a 6% decrease in the average price paid by hospitals ...Learn More
Elekta wins clearance for brachytherapy system in China
Chinese regulators have granted Elekta, which develops radiation oncology systems, clearance to market its Flexitron ...Learn More
179-gene panel shows 78% success rate in detecting gene mutation
A study in PLOS ONE shows how effective a next-generation sequencing multiplex assay can be in analyzing and identifying ...Learn More
MolecularMD NGS lab accredited by CAP
The College of American Pathologists has accredited the next-generation sequencing laboratory operated by MolecularMD in ...Learn More
Paramed Medical announces new MROpen scanner applications
Paramed Medical Systems is set to expand its MROpen scanner clinical applications in 2015 by offering applications for ...Learn More
Updated home heart monitor from AliveCor set to launch in January
An upgraded version of AliveCor's home heart monitor is set to launch in January on Amazon.com and through a collaboration ...Learn More
Surgical sealant from Cohera wins FDA priority review status
The FDA has given priority review status to Cohera Medical's Sylys Surgical Sealant. ...Learn More
FDA clears Memo3d ReChord implant from Sorin Group
The Memo3d ReChord, a surgical implant developed by Sorin Group, has obtained 510(k) clearance from the FDA. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Life is a blank canvas, and you need to throw all the paint on it you can.
Danny Kaye, American actor and ...Learn More
Royal Philips to acquire Volcano in $1.2B deal
Royal Philips announced Wednesday it will purchase Volcano and its cardiovascular imaging technology, including its debt, ...Learn More
Varian to purchase German firm MeVis in $37M-plus deal
Varian Medical Systems has agreed to purchase MeVis Medical Solutions for nearly $37.3 million in a deal that is anticipated ...Learn More
Orthopedic device developer secures $12M investment
Sonoma Orthopedic Products has obtained a $12 million boost from private growth-equity investor First Analysis. ...Learn More
FDA, HHS awards joint Dx development contract to Diatherix
Diatherix Laboratories has entered a one-year joint contract with the FDA and HHS. ...Learn More
Firm earns CE mark for PEEK-OPTIMA HA implant
Karmed Saglik Group has obtained the CE mark for its first implant developed using the PEEK-OPTIMA HA Enhanced implantable ...Learn More
DeviceTalks podcast: Masimo CEO Kiani talks patient safety, corporate culture and debunking the "innovators dilemma"
An interview with medtech entrepreneur Joe Kiani, CEO of Masimo Corp. ...Learn More
Trial set to evaluate VolitionRx's lung cancer assay
A clinical trial is set to get underway at the University of Bonn in Germany to evaluate VolitionRx's Nucleosomics platform, ...Learn More
Dutch study validates use of thrombectomy devices for treating stroke
Thrombectomy devices demonstrated positive results in a Dutch trial involving 500 acute ischemic stroke patients. ...Learn More
Integra to debut skin regeneration template for burns, scars
Integra LifeSciences is set to expand its skin repair product line in January with the introduction of its Meshed Dermal ...Learn More
FDA clears surgical system from THINK Surgical
The TSolution One Surgical System developed by THINK Surgical has obtained 510(k) clearance from the FDA. ...Learn More
Cerus' Intercept Blood System wins FDA approval
Cerus has received FDA approval for its Intercept Blood System. ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's the steady, quiet, plodding ones who win in the lifelong race.
Robert Service, British-Canadian ...Learn More
Medtronic-Covidien deal wins all required anti-trust approvals
Medtronic announced that it has gained the necessary approvals from U.S., European Union, Canadian, Chinese and South Korean ...Learn More
Mass. gives $1M for development of hand-held Ebola Dx device
Diagnostics for All has been awarded a $1 million grant from the state of Massachusetts to help fund the development of a ...Learn More
CytoSorbents taps Fresenius Medical Care to offer product in Europe
CytoSorbents has secured a distribution deal with Fresenius Medical Care to help bring its CytoSorb blood purification ...Learn More
In vitro Dx company completes part of funding round
Protagen, a developer of in vitro diagnostic tests for diseases including systemic sclerosis and rheumatoid arthritis, has ...Learn More
U.K. oncology Dx firm to get $19.7M boost
Investment company Syncona Partners will pump $19.7 million in equity financing into U.K.-based 14M Genomics, a developer of ...Learn More
CVRx wins expanded EU approval for Barostim neo
CVRx has earned additional clearance from the European Union for its Barostim neo carotid artery pulse stimulator. ...Learn More
FDA allows InVivo Therapeutics to speed up trial enrollment
InVivo Therapeutics has received the FDA's approval to expedite the patient enrollment in its Neuro-Spinal Scaffold trial. ...Learn More
FDA OKs injection system from VEXIM
The Masterflow Injection System developed by VEXIM has obtained marketing authorization in the U.S. from the FDA. ...Learn More
FDA clears 3 devices from Merit Medical Systems
The AEROmini tracheobronchial stent system, the ReSolve biliary locking drainage catheter and the ONE Snare line of ...Learn More
Stent planning tool from Vital Images gains FDA clearance
The FDA has granted Vital Images 510(k) clearance to market its fenestrated stent planning tool. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
I dwell in Possibility.
Emily Dickinson, American ...Learn More
Analysis: Medtech M&A activity surges in 2014
A MassDevice.com analysis found that the value of merger and acquisition deals in the medical device sector increased almost ...Learn More
Funding round brings in $59M for InSightec
A round of Series D financing has pulled in $59 million for InSightec, developer of the EU-approved ExAblate MR-guided ...Learn More
Exact Sciences announces public stock sale
Exact Sciences announced Monday that it is selling 4 million shares in a public offering. ...Learn More
Europe expands approval for Roche's Cobas assays
Roche has earned additional approval from European Union regulators for the use of Cobas MPX and Cobas WNV assays to test ...Learn More
U.K. genomic firm signs distribution deal with AutoGen
LGC, which operates in the U.K., has entered into a distribution deal with AutoGen for undisclosed terms. ...Learn More
FDA approves study of Brainsway's device for PTSD
The FDA has granted Brainsway an investigational device exemption to conduct a 166-patient trial to evaluate the efficiency ...Learn More
Medtronic debuts NovaShield injectable gel for sinus surgery
Medtronic has launched its NovaShield Injectable Nasal Packing and Stent, which is designed for use following functional ...Learn More
Firms win most innovative award for needle safety device
The 2014 DeviceMed award for most innovative device was given to German medtech component maker Raumedic AG and the ...Learn More
FDA clears 3D arthroplasty planning software from EOS
The hipEOS 3D hip arthroplasty planning software developed by orthopedic digital X-ray company EOS Imaging has obtained FDA ...Learn More
Blood test to estimate heart disease risk receives FDA approval
A blood test developed by diaDexus that determines coronary heart disease risk in people with no history of heart disease ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Never mistake motion for action.
Ernest Hemingway, American ...Learn More
Wright Therapy receives $4.4M boost from investors
A group of investors has pumped about $4.4 million into Wright Therapy Products, which developed a device for lymphedema ...Learn More
Equity round brings in $3M for ForSight Vision6
ForSight Vision6, based in Menlo Park, Calif., has pulled in $3 million in an equity round with five undisclosed investors, ...Learn More
K2M Group plans to move headquarters to Va.
K2M Group is moving its headquarters and R&D facility to Leesburg, Va. ...Learn More
Orthopedic device company secures $575K
OrthogenRx, an orthopedic device company, has raised $575,000 in financing from Ben Franklin Technology Partners. ...Learn More
German firm Sygnis pulls in $6.2M in financing
Sygnis, the German developer of the TruePrime Single Cell WGA kit, has closed its rights offering and secured a total of ...Learn More
SDRI enters European distribution deal with joimax
California-based joimax has agreed to to bring Synergy Disc Replacement's SYNERGY Cervical Disc to Germany, Austria and ...Learn More
Firm commences trial for staph ID/R test
Great Basin Scientific is beginning a trial for its staph identification/resistance molecular assay. ...Learn More
New trial begins for Stimwave's chronic back pain device
A new randomized, placebo-controlled trial has been launched by Stimwave Technologies to test the use of its wireless ...Learn More
Alere's rapid HIV test gains FDA waiver
Alere obtained a waiver from the FDA for the expanded use of its Determine HIV-1/2 Ag/Ab Combo test. ...Learn More
FDA review may result in removal of devices from high-risk category
Some devices may be bumped off the highest-risk category after the FDA finishes the review of its premarket approval ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Some of us think holding on makes us strong; but sometimes it is letting go.
Hermann Hesse, German-Swiss writer and ...Learn More
Mass. developer of image management tech obtains $8M
Image Stream Medical has pulled in $8 million from a sole anonymous investor in a new equity offering, according to a ...Learn More
Roche strikes deal to purchase AvanSci Bio's MilliSect products
Roche Diagnostics agreed to acquire the entire MilliSect tissue extraction product line from AvanSci Bio. ...Learn More
Claritas Genomics taps NextCode Health for Dx interpretations
Cambridge, Mass.-based Claritas Genomics, a provider of clinical diagnostic tests including the ClariFocus Exome for ...Learn More
Swedish genomic firm gains rights to license ValidPrime technology
Tataa Biocenter, which is based in Goteborg, Sweden, has struck a licensing deal with the French Institute for Health and ...Learn More
Abbott wins CE mark approval for Iridica platform
Abbott has earned the CE mark for its Iridica pathogen detection platform, which can determine even infrequent pathogens. ...Learn More
EU approves St. Jude's Quadra Allure MP pacemaker
European regulators have granted CE mark approval to St. ...Learn More
Transcatheter Technologies announces new transcatheter valve
Transcatheter Technologies, maker of the Trinity transcatheter aortic valve implant, announced the newest version to its ...Learn More
Cianna Medical wins FDA nod for breast tumor device
The FDA has granted clearance for California-based Cianna Medical's Strut-Adjusted Volume Implant SCOUT system, a breast ...Learn More
FDA approves endoprosthesis from Gore Medical
The GORE VIABAHN endoprosthesis, developed by Flagstaff, Ariz.-based Gore Medical, has obtained FDA approval for use in ...Learn More
Defibrillator leads from Medtronic gain premarket approval
The FDA has given premarket approval to Medtronic for new additions to its Attain Performa line of quadripolar cardiac ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
The future cannot be predicted, but futures can be invented.
Dennis Gabor, Hungarian-British electrical engineer and ...Learn More
Medtech sector IPO filings jumped in 2014, analysis shows
An analysis by MassDevice.com found that the medical device sector filed for 25 initial public offerings this year, up from ...Learn More
Minn. lumbar spinal device maker receives $2M boost
An equity-and-options round has pulled in $2 million for Zyga Technology, maker of lumbar spinal surgical devices, including ...Learn More
UTI Dx startup lands investment from BioGenerator
BacterioScan, a startup working on a urinary tract infection diagnostics device, has received an undisclosed investment from ...Learn More
NIH backs development of Ebola rapid detection assay
David Alland, a researcher from Rutgers New Jersey Medical School, has received a $640,000 supplement grant from the NIH to ...Learn More
Synergetics pays $13.5M for U.K. eye surgical tool firm
Synergetics USA announced its $13.5 million acquisition of Sterimedix, a British company specializing in eye surgical tools. ...Learn More
Intrinsic Therapeutics wraps up trial enrollment for anular closure device
Intrinsic Therapeutics has finished enrolling patients for a trial evaluating its Barricaid anular closure device for lumbar ...Learn More
Hunter Medical unveils elbow surgical assist device
The ElbowLOC Arm Positioning System is now available commercially, according to Hunter Medical. ...Learn More
Patient, industry groups weigh in on FDA policies
AdvaMed, the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America joined patient ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Bordetella Assay developed by Quidel has obtained clearance from the FDA. ...Learn More
FDA delays premarket review of VertiFlex spine implant
The FDA has moved an advisory panel meeting for VertiFlex's Superion spine implant to Feb. 20 for undisclosed reasons. ...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
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
What concerns should medical device companies focus on in the coming year?
A painting that is well-composed is half-finished.
Pierre Bonnard, French ...Learn More
N.J. ischemia implantable device maker raises over $10.2M in debt offering
Angel Medical Systems has obtained over $10.2 million toward its goal of $20.5 million in a debt offering, according to a ...Learn More
CareFusion plans to vote on Becton Dickinson merger in January
CareFusion has scheduled a shareholders meeting Jan. ...Learn More
Welch Allyn buys assets of Neb. remote patient monitoring firm
Welch Allyn announced it has acquired the assets of HealthInterlink, the Omaha, Neb.-based maker of the Beacon 2.0 remote ...Learn More
French molecular Dx firm gets $3.8M boost
Novocyte has secured $3.8 million in a private equity financing round joined by Alto Invest. ...Learn More
Canada OKs spinal surgery implant from Aurora Spine
Aurora Spine's ZIP MIS Interspinous Fusion System was granted the Health Canada Medical Device License. ...Learn More
Trial enrollment for Biotronik's ProMRI pacemaker completed
Biotronik announced that patient enrollment and planned MRI studies in phase B of its analysis of its ProMRI pacemakers have ...Learn More
Positive results reported in 2 studies of Medtronic's stent graft
Medtronic's Endurant AAA stent graft demonstrated promising results in two long-term studies. ...Learn More
FDA clears retinal imaging system from CenterVue
The FDA has given CenterVue 510(k) clearance to market Eidon, a retinal imaging system. ...Learn More
Siemens seeks FDA clearance for CT lung cancer screening
Siemens Healthcare has submitted an application seeking 510(k) clearance from the FDA to market its Lung Low Dose Protocol ...Learn More
Focus Diagnostics gets additional clearance for flu strain assays
Focus Diagnostics has received additional clearance from the FDA for eight other influenza strains on its Simplexa Flu A/B & ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
What trend in medical device technology had the biggest impact in the past year?
Respect your efforts, respect yourself. Self-respect leads to self-discipline. When you have both firmly under your belt, that's real power.
Clint Eastwood, American actor and ...Learn More
Amedica brings in nearly $13M from IPO
Amedica raised close to $13 million in gross proceeds from its now-closed underwritten public offering that started Nov. 26. ...Learn More
CardioKinetix secures $50M in funding, exclusive acquisition deal
CardioKinetix, a developer of cardiac devices including the Parachute ventricular partitioning device, has received $50 ...Learn More
Orthopedic surgery kit developer gets $2.2M boost
A private stock sale has pulled in $2.2 million for Flower Orthopedics, according to a Securities and Exchange Commission ...Learn More
Symmetry Medical completes spinout of surgical unit
Symmetry Medical has successfully spun off its surgical instrumentation unit, Symmetry Surgical. ...Learn More
European firm purchases Boston Heart Diagnostics
Eurofins Scientific, a Luxembourg-based bioanalytical testing firm, has agreed to acquire Boston Heart Diagnostics for $140 ...Learn More
Victorian Clinical Genetics Services, Illumina collaborate on prenatal assay
A partnership deal to create a noninvasive prenatal test has been reached between Illumina and Victorian Clinical Genetics ...Learn More
EU approves HIV, HCV molecular Dx from Roche
European regulators have granted Roche CE mark approval for its Cobas HIV-1 and HCV assays. ...Learn More
ExThera's blood-filtering device eliminates drug-resistant bacteria in study
ExThera Medical has released data from a study which evaluated its Seraph blood-filtering device. ...Learn More
Siemens introduces updated SOMATOM Definition Edge CT
Siemens has launched an upgraded version of the SOMATOM Definition Edge CT. ...Learn More
Prosigna assay from NanoString receives new FDA labeling
The FDA has issued an update for the labeling of NanoString's Prosigna Breast Cancer Gene Signature Assay, which received ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Which medical device issue do you encounter most often?
Knowing your own darkness is the best method for dealing with the darknesses of other people.
Carl Jung, Swiss ...Learn More
Becton Dickinson looks to offer $6.2B in senior notes
Becton Dickinson announced that it will sell five sets of senior unsecured bonds worth a total of $6.2 billion, which are ...Learn More
Robotic exoskeleton developer obtains nearly $23M in funding
Ekso Bionics, a firm developing an FDA-approved wearable robotic exoskeleton to help paralyzed or movement-impaired patients ...Learn More
Symmetry Medical's merger, business unit sale get shareholders' OK
Shareholders of Symmetry Medical have voted in favor of approving the company's pending merger with TecoStar, Tecomet and ...Learn More
Qiagen, Altona sign distribution deal for Ebola testing kit
Qiagen has agreed to globally distribute Altona Diagnostics' RealStar Ebolavirus RT-PCR Kit 1.0, a testing kit capable of ...Learn More
Report: BRIC diagnostic imaging markets could hit $7.6B by 2018
A MarketsandMarkets report predicts that the diagnostic imaging markets in Brazil, Russia, India and China will reach $7.6 ...Learn More
Roche to purchase U.S. molecular Dx firm
Switzerland-based Roche Holdings agreed to purchase U.S. ...Learn More
German sequencing, Dx firm plans to restructure
GATC Biotech, a sequencing services and diagnostics firm based in Germany, said it plans to reorganize its business into ...Learn More
Study links St. Jude Medical's Optim leads to lower failure rates
St. ...Learn More
Calif. hospital installs Mazor Robotics Renaissance system
Long Beach, Calif.-based Dignity Health St. ...Learn More
Fiagon wins FDA clearance for extended instrument set
The ear, nose and throat extended instrument set developed by Fiagon has obtained 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, 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
There are dark shadows on the earth, but its lights are stronger in the contrast.
Charles Dickens, British ...Learn More
Mass. cartilage repair device firm lowers IPO target to $57.2M
Massachusetts-based Histogenics is looking to obtain $57.2 million with the launch of its initial public offering Wednesday, ...Learn More
Calif. replacement heart valve firm gets $32M boost
A funding round has brought in $32 million for Santa Rosa, Calif.-based Direct Flow Medical. ...Learn More
Teleflex enters marketing deal with group purchasing organization
Teleflex has agreed to supply Premier's network of hospitals and health care providers with its current and future dialysis ...Learn More
eBioscience strikes distribution agreement with U.K. supplier
Affymetrix unit eBioscience has struck a distribution deal with The Binding Site, a diagnostic tools supplier based in the ...Learn More
Danish Dx firm secures exclusive license for prostate cancer biomarkers
Aarhus University Hospital has given Exiqon, a Denmark-based diagnostics maker, an exclusive license to prostate cancer ...Learn More
Podcast: B. Braun Medical CEO on the medical device tax, health care law and innovation
Caroll Neubauer, the CEO of B. ...Learn More
Trial enrollment for Spinal Modulation's neurostimulator system closed
Spinal Modulation has wrapped up patient enrollment for a clinical trial evaluating its Axium Neurostimulator System, an ...Learn More
Firms partner for cancer immune response biomarker
An agreement between OncoSec Medical, PerkinElmer and the University of California, Los Angeles, will focus on creating ...Learn More
Spineart gains approval from FDA for posterior axial device
The FDA has given Spineart 510(k) clearance to market the ROMEO2 PAD, a posterior axial device with 30 degrees of plate ...Learn More
Paragonix wins additional FDA clearance for organ transport system
Paragonix Technologies, the developer of the Sherpa Pak organ transport systems, has obtained additional FDA clearance to ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Our finest moments are most likely to occur when we are feeling deeply uncomfortable, unhappy or unfulfilled. For it is only in such moments, propelled by our discomfort, that we are likely to step out of our ruts and start searching for different ways...
M. Scott Peck, American ...Learn More
Minn. maker of fracture implant device secures $24M
A round of Series AA financing has pulled in $24 million for Conventus Orthopaedics. ...Learn More
Healthtell receives NIH funding to evaluate brain cancer Dx
The NIH has awarded a $225,000 Small Business Innovation Research grant to Healthtell to finance an effectiveness study on ...Learn More
US Medical Innovations signs distribution deal with CrossLink Surgical
US Medical Innovations has entered into a distribution deal with CrossLink Surgical. ...Learn More
N-of-One partners with cancer genetics Dx firm
N-of-One has entered into an agreement with NeoGenomics for an undisclosed sum to interpret test results generated by the ...Learn More
Swiss medtech firm obtains $34M in Series B financing
Xeltis, whose first product is a replacement pulmonary valve that can stimulate regeneration of new coronary valves and ...Learn More
Integrated DNA Technologies, Ubiquitome collaborate on handheld Ebola assay
Integrated DNA Technologies has agreed to work with Ubiquitome, a New Zealand-based startup, to create a handheld Ebola test ...Learn More
Device provides docs with real-time feedback on radiation exposure
Interventional cardiologists who wore the Bleeper SV radiation monitoring device while in the cath lab were exposed to lower ...Learn More
Spinal fusion system from Benvenue Medical wins FDA nod
The Luna 360 Interbody Fusion System developed by Benvenue Medical has obtained 510(k) clearance from the FDA. ...Learn More
FDA clears injectable pain relief device from Stimwave
The FDA has given Stimwave clearance to market its Freedom Spinal Cord Stimulator System in the U.S. ...Learn More
Delphinus' SoftVue system gains additional FDA clearance
The FDA has granted Delphinus Medical Technologies an additional 510(k) clearance for its SoftVue system, this time for the ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...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
The one thing all famous authors, world-class athletes, business tycoons, singers, actors, and celebrated achievers in any field have in common is that they all began their journeys when they were none of these things.
Mike Dooley, American ...Learn More
Medtronic raises $17B in seven-part debt offering
Medtronic has secured $17 billion through a seven-tranche debt offering to help fund the company's $42 billion acquisition ...Learn More
Minn. medical device firm gets $7.5M boost
Interrad Medical, a medical device firm based in Plymouth, Minn., has obtained $7.5 million in a financing round led by ...Learn More
Philips gains license rights to RaySafe S1 X-ray dose system
Royal Philips was granted an exclusive license for the RaySafe S1 X-ray dose-managing system developed by Unfors RaySafe, a ...Learn More
23andMe wins CE mark approval for genetic analysis kit
European regulators have granted CE mark approval for 23andMe's Personal Genome Service spit kits, which performs genetic ...Learn More
EU approves Aptima HIV-1 Quant Dx assay from Hologic
Hologic has earned the CE mark for its Aptima HIV-1 Quant Dx assay, an HIV viral load assay that features real-time, ...Learn More
Trial enrollment for Cardiovascular Systems' atherectomy system closed
Cardiovascular Systems has wrapped up patient enrollment in Japan for a clinical study on its second-generation micro-crown ...Learn More
Thoratec wraps up trial enrollment for heart pump
Pleasanton, Calif.-based Thoratec has finished enrolling patients for a clinical trial evaluating its HeartMate III left ...Learn More
J&J unit wins FDA approval for insulin pump system
Animas, a subsidiary of Johnson & Johnson Diabetes Solutions, has obtained FDA approval for its Animas Vibe insulin pump and ...Learn More
FDA OKs in vitro Dx assay from Cepheid
Cepheid has secured FDA clearance to market its Xpert Norovirus assay, which runs on the company's GeneXpert platform. ...Learn More
FDA clears Turnpike catheters from Vascular Solutions
The FDA granted Vascular Solutions 510(k) clearance to market its Turnpike catheter, which features a dual-layer coil inside ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The bird a nest, the spider a web, man friendship.
William Blake, British painter and ...Learn More
FTC, EU approve $43B Medtronic-Covidien deal
Medtronic received approval from the U.S. ...Learn More
Genomics gets $12.8M boost for genomic sequencing analysis
Genomics has secured $12.8 million in a private financing round that included the IP Group, the University of Oxford and ...Learn More
Brain injury device maker takes in almost $4.2M in debt financing
X2 Biosystems, a brain injury device developer based in Seattle, has brought in about $4.2 million through a debt and ...Learn More
Diagnostics innovation hub launched in Singapore
A Diagnostics Development Hub has been created by the Singapore Agency for Science and Technology Research to speed up the ...Learn More
Neuromod wins approval for tinnitus device in Europe
A multisensory device for treating tinnitus developed by Neuromod Devices has obtained CE mark approval in Europe. ...Learn More
U.S. patent issued to Acertara's probe testing device
The number of U.S. ...Learn More
Centinel Spine's new lumbar interbody fusion device due out in early 2015
Centinel Spine announced that its newest STALIF Family Lumbar Integrated Interbody fusion device, the MIDLINE II, will be ...Learn More
Konica Minolta introduces portable ultrasound system
Sonimage HS1, a handheld ultrasound system featuring an advanced transducer and a broadband linear probe, was launched by ...Learn More
AdvaMed commends Japanese medtech regulations
Japan's adoption of new medical device regulations will make the regulatory process easier for device manufacturers, said ...Learn More
For more:
Read the AdvaMed press release for President and CEO Stephen Ubl's comments about the new medtech regulatory framework in ...Learn More
Enhanced CT imaging system from Philips wins FDA nod
The IQon Spectral CT system developed by Royal Philips has received 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Bring ideas in and entertain them royally, for one of them may be the king.
Mark Van Doren, American poet and ...Learn More
B. Braun drops plans to expand headquarters over device tax costs
Series C round pulls in $5M for iHear Medical hearing aids
iHear Medical has obtained $5 million in a Series C financing round. ...Learn More
Thermo, Samsung to work on point-of-care Dx solutions
Thermo Fisher Scientific and Samsung Electronics have partnered to create and commercialize point-of-care diagnostic ...Learn More
ProMedica opens medtech startup incubator in Ohio
ProMedica Health System has begun the ProMedica Innovations incubator for medical device and bioinformatics startups in ...Learn More
InSightec gets Japanese approval for ExAblate system
Japanese regulators have given InSightec clearance to market ExAblate, a magnetic resonance-guided, focused ultrasound ...Learn More
Device could reduce pressure, pain during mammograms
A team of researchers from the Netherlands has come up with a device that could reduce pain experienced during breast ...Learn More
New patent issued to Spineology for spinal fusion system
Spineology has secured a patent for a percutaneous spinal interbody fusion system, covering implants, instrumentation and ...Learn More
FDA clears lumbar spinal device from Interventional Spine
The FDA has granted Interventional Spine clearance for the Lateral Opticage Expandable Intervertebral Body Fusion Device. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities. ...Learn More
AdvaMed SmartBrief will not publish Thursday and Friday
In observance of Thanksgiving in the U.S., AdvaMed SmartBrief will not publish Thursday and Friday. ...Learn More
Courage is the capacity to confront what can be imagined.
Leo Rosten, Russian-American teacher and ...Learn More
Second Sight earns over $36M from IPO
The initial public offering last week of Second Sight Medical pulled in $36.2 million for the company after the underwriter, ...Learn More
Maker of cloud-based monitoring platform obtains $17M
The second tranche of InfoBionic's Series B funding round has pulled in $17 million, which it will use to advance the U.S. ...Learn More
Kelyniam Global buys implantable device maker
Kelyniam Global, a cranial and facial implant maker based in Canton, Conn., announced its acquisition of Med-Ally for an ...Learn More
Horizon Discovery enters partnership with Adarza Biosystems
Horizon Discovery Group has agreed to a licensing and supply deal with Adarza Biosystems for an undisclosed sum. ...Learn More
German molecular Dx firm obtains $18M in funding extension
Curetis has brought in $18 million in a Series B financing round extension through the investments of Qiagen and the LSP ...Learn More
FDA OKs study of Cerus' plasma treatment system
The FDA has granted Cerus an investigational device exemption for clinical studies of its INTERCEPT Blood System, a ...Learn More
Microfluidic chip reduces amount of blood needed for testing
Scientists at the Indian Institute of Technology-Bombay have designed a microfluidic chip for blood separation that requires ...Learn More
FDA clears balloon catheter from Covidien
The FDA has given Covidien 510(k) clearance to market the Fortrex PTA balloon catheter. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
The secret of business is to know something that nobody else knows.
Aristotle Onassis, Greek shipping ...Learn More
Calif. bioresorbable stent firm gets $25M boost
Reva Medical has secured $25 million to support current operations and advance its products, the San Diego-based firm ...Learn More
Aneurysm device startup obtains $7M in funding
Aortica, a startup developing a patient-specific device to treat abdominal aortic aneurysms, has raised $7 million in a ...Learn More
U.S. antitrust waiting period ends for Becton Dickinson-CareFusion deal
Becton Dickinson now awaits approval from CareFusion shareholders in its bid to buy the company, as well as the OK from ...Learn More
CareDx ends lupus flare test collaboration with LabCorp
CareDx and Laboratory Corp. ...Learn More
EU approves Covidien's Nellcor oxygen monitor
European regulators have granted CE mark approval for Covidien's Nellcor bedside SpO2 patient monitoring device, which ...Learn More
CoorsTek Medical purchases Italian medtech firm
CoorsTek Medical announced its acquisition of Nanosurfaces Industries, the Italian device manufacturing unit of European ...Learn More
Faxitron to introduce high-resolution detector for new systems
Faxitron Bioptics is set to launch a high-resolution, complementary metal-oxide semiconductor digital detector for its ...Learn More
FDA clears BrainScope's brain trauma device
The Ahead 100 device, developed by Bethesda, Md.-based company BrainScope, has received clearance from the FDA. ...Learn More
FDA extends timeline for UDI marking compliance for certain orthopedic implants
Labelers of certain single-use orthopedic implants will have until Sept. ...Learn More
Low-dose portable X-ray system from Kubtec wins FDA OK
Kubtec has gained approval from the FDA to launch its KUB 250, a portable digital X-ray system designed to cut radiation ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, 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
A broken bone can heal, but the wound a word opens can fester forever.
Jessamyn West, American ...Learn More
BioNano Genomics gets $53M boost to advance Irys platform
BioNano Genomics, a San Diego-based developer of genome mapping platforms, has obtained $53 million in a Series C funding ...Learn More
Funding round brings in $7.5M for molecular Dx startup
A round of Series A financing headed by Sherpa Ventures has pulled in $7.5 million for molecular diagnostics startup Cue. ...Learn More
Hospital GPO awards supply contract to Medical Imaging Solutions International
Medical Imaging Solutions International has entered into a supply agreement with Premier, a hospital group purchasing ...Learn More
New Zealand, Australia drop proposal to form joint regulatory body
A plan by New Zealand and Australia to create a single agency to regulate the medical device sector in both countries has ...Learn More
Canada releases guidance for new medtech license applications
Medical device manufacturers are required to submit license applications for Class III and Class IV devices in Canada via ...Learn More
Firms to develop advanced sequencing technology for infection monitoring
Illumina and bioMerieux agreed to collaborate in the development of applications for microbiology sequencing technologies. ...Learn More
Mich. health system to use firm's proton therapy system
The ProteusOne single-room proton therapy device developed by Ion Beam Applications will be installed at the Beaumont Health ...Learn More
SpineDriver to launch battery-powered device for drilling into spine
SpineDriver unveiled its newest battery-powered device to drill and drive pedicle screws into the spine at a spinal care ...Learn More
Accuray reports N.Y. installation of CyberKnife M6 system
Accuray has installed its CyberKnife M6 radiosurgery system at Winthrop-University Hospital's NYCyberKnife Center in ...Learn More
FDA OK sought by Great Basin Scientific for Group B strep test
Great Basin Scientific has submitted a 510(k) clearance application to the FDA for use of its Group B strep test in ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Men stumble over pebbles, never over mountains.
H. Emilie Cady, American ...Learn More
IPO pulls in $31.5M for Second Sight
An initial public offering Wednesday brought in $31.5 million for artificial retina developer Second Sight Medical Products. ...Learn More
Biomarker firm obtains $2.3M in funding for autism study
The Nancy Lurie Marks Family Foundation has given Stemina Biomarker Discovery $2.3 million to finance its study of autism ...Learn More
Company receives NIH funding to improve antibiotic delivery of implants
The NIH has given a $150,000 grant to Oxford Performance Materials to fund a study on treating infections caused by ...Learn More
Brazil seeks feedback on medtech quality inspections proposal
Medical device manufacturers may opt to provide feedback on how their quality management inspections were conducted under ...Learn More
Genetic Technologies wraps up sale of Australian subsidiary
The sale of Genetic Technologies' Australian Genetics unit to Specialist Diagnostics Services for $1.7 million has been ...Learn More
CardioMEMS device from St. Jude reduces 30-day readmissions
Data from St. ...Learn More
Boston Scientific's Synergy stent passes Evolve II trial
Boston Scientific's Synergy stent passed the Evolve II trial, where it was put against drug-eluting stent Promus, the ...Learn More
OrthoGrid launches device for better total hip replacement
HipGrid, an FDA-approved device designed for better positioning and alignment during total hip replacement, has been ...Learn More
Colonoscopy imaging device from Avantis wins FDA OK
The Third Eye Panoramic device, developed by Avantis Medical Systems, has obtained 510(k) clearance from the FDA. ...Learn More
FDA gives green light to IlluminOss' bone fracture device study
The FDA has given IlluminOss Medical conditional clearance to conduct a clinical study to test the use of its photodynamic ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...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 think a hero is any person really intent on making this a better place for all people.
Maya Angelou, American ...Learn More
Royal Philips agrees to sale of InnerCool business to Zoll Medical
Zoll Medical will acquire Royal Philips' InnerCool temperature management business, including the FDA-cleared Accutrol ...Learn More
Genetic Signatures aims to bring in $13.1M in IPO
Genetic Signatures, the molecular diagnostics company behind the EasyScreen PCR pathogen detection kits, is looking to ...Learn More
New heart devices boost Medtronic's Q2 revenue
Medtronic saw a 4% increase in its second-quarter revenue to $4.37 billion, driven in part by sales from its new heart ...Learn More
Wis. blood center taps N-of-One for oncology testing services
The BloodCenter of Wisconsin has entered into an oncology testing partnership with N-of-One for undisclosed terms. ...Learn More
Zimmer agrees to longer EU review of Biomet deal
The European Commission has reached an agreement with Zimmer to extend an antitrust review of the company's pending ...Learn More
Partnership aims to investigate arrhythmia in dialysis patients
DaVita Healthcare Partners will work with Medtronic on a pilot effort to use the latter's Reveal LINQ Insertable Cardiac ...Learn More
FDA clears spinal fusion implant from Aurora Spine
The ZIP 51, developed by Aurora Spine and part of the company's Aurora Spine MIS Fusion System, has obtained 510(k) ...Learn More
Toshiba to launch updated CT and new PET/CT systems
Toshiba has announced updates to its Aquilion CT scanners and the release of its Celesteion PET/CT system. ...Learn More
Industry groups call for extension of tax credits
Over 500 businesses and industry groups, including AdvaMed, have signed a letter to Congress asking for the renewal of some ...Learn More
Rapid MRSA detection assay from AdvanDx wins FDA nod
The FDA has given AdvanDx 510(k) clearance to market its mecA XpressFISH assay for detecting methicillin-resistant and ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, 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
It is always our own self that we find at the end of the journey. The sooner we face that self, the better.
Ella Maillart, Swiss travel ...Learn More
Medtronic to hold shareholder vote in January on Covidien buy
Medtronic has scheduled a special shareholder meeting Jan. ...Learn More
Regenerative medicine firm targets $60M in IPO
Waltham, Mass.-based Histogenics is looking to obtain $60 million with its initial public offering. ...Learn More
Valeant to pay up to $20M for Nicox's U.S. ophthalmic Dx unit
Valeant Pharmaceuticals has agreed to acquire Nicox's U.S. ...Learn More
Partnership aims to develop in vitro Dx kit for MRD
Sequenta has agreed to work with Illumina to develop and market an in vitro diagnostic kit that can be used to detect and ...Learn More
Protagen taps Qiagen in long-term companion Dx deal
An agreement reached by Protagen and Qiagen will focus on further developing protein-based companion diagnostic tests to ...Learn More
Bone Therapeutics to develop spinal fusion device with French firm
French firm Kasios will combine its synthetic microgranules bone substitute with Bone Therapeutics' ALLOB allogeneic ...Learn More
Covidien's VenaSeal offers promising treatment for chronic leg vein disorders
A study conducted by Covidien shows that the effectiveness of its new VenaSeal system as a treatment for chronic leg vein ...Learn More
NFL funds further development of concussion detection device
The University of Miami's Miller School of Medicine has secured a $500,000 grant from the National Football League, which it ...Learn More
EKF Diagnostics launches hemoglobin analyzer
EKF Diagnostics has introduced its DiaSpect TM point-of-care hemoglobin analyzer that can deliver results in a second. ...Learn More
Medtech firms express concern over EPA stance on sterilizer
The Environmental Protection Agency's draft assessment concluding that ethylene oxide, which is used to sterilize medical ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
When nothing seems to help, I go look at a stone-cutter hammering away at his rock perhaps a hundred times without as much as a crack showing in it. Yet at the hundred and first blow it will split in two, and I know it was not that blow that did it,...
Jacob Riis, Danish-American social ...Learn More
Heart valve implant maker obtains nearly $11M boost
JenaValve Technology has pulled in almost $11 million in a round of Series C financing, raising a total of $73.4 million in ...Learn More
Boston Scientific scores reimbursement wins for heart device
Boston Scientific has announced that starting Jan. ...Learn More
DermTech files to withdraw IPO proposal
DermTech, a California-based company specializing in tests to diagnose melanoma and other skin conditions, has filed to ...Learn More
Unilife taps Flextronics to expand production capacity
Unilife, which specializes in drug-delivery systems, has entered a global strategic deal with Flextonics for an undisclosed ...Learn More
Beckman Coulter enters molecular Dx deal with Seegene
Seegene, a South Korea-based firm, has agreed to a molecular diagnostics deal with Beckman Coulter to produce reagents ...Learn More
Nico enters partnership with Canadian firm for neurosurgery system
Nico and Synaptive Medical, a Toronto-based 3D visualization company, have struck a deal to work together on a neurosurgery ...Learn More
Study underway for Zyga's lumbar facet pain syndrome device
A patient at the Greater Baltimore Medical Center has become the first to be implanted with the Glyder Facet Restoration ...Learn More
Aethlon's Hemopurifier reduces Ebola viral load, case report suggests
Doctors from Goethe University in Germany reported at the Kidney Week conference that Aethlon's Hemopurifier helped reduce ...Learn More
FDA authorizes emergency use of Altona's Ebola testing kit
Altona Diagnostics announced that the FDA has authorized the emergency use of its RealStar Ebolavirus RT-PCR Kit 1.0, an in ...Learn More
FDA taps medical center to assist in Sentinel drug, device monitoring program
The Vanderbilt University Medical Center was enlisted by the FDA to offer research expertise to the agency's Sentinel System ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Failure will never overtake me if my determination to succeed is strong enough.
Og Mandino, American ...Learn More
U.S., EU regulators OK Endurant IIs stent graft from Medtronic
Medtronic's new Endurant IIs AAA endovascular stent graft, which is used to treat abdominal aortic aneurysms, has received ...Learn More
Monteris obtains $30M for robotic laser surgery platform
The first tranche of a Series B funding round has brought in $30 million for Minnesota-based Monteris Medical. ...Learn More
Medtronic grants natriuretic peptide rights to Capricor
Capricor Therapeutics secured the patent rights for the formulation and delivery of natriuretic peptides from Medtronic for ...Learn More
C. difficile test drives Q3 revenue growth for Great Basin
Utah-based Great Basin Scientific generated $404,390 in revenue during the third quarter, compared with $223,470 in the same ...Learn More
New Oncology signs cancer Dx deal in Singapore
The National Cancer Centre Singapore has entered into a cancer diagnostics partnership with Germany-based New Oncology for ...Learn More
Molecular Dx firm obtains up to $3.3M for Ebola diagnostic test
The Bill & Melinda Gates Foundation and the Paul G. ...Learn More
Roche's Group A strep test scores FDA clearance
The FDA has cleared Roche to market a polymerase chain reaction-based test that can identify the presence of Group A ...Learn More
Integra announces U.S. release of expandable interbody device
Integra LifeSciences said its first expandable interbody device, the FDA-cleared Integra Expandable Interbody System, is now ...Learn More
Lawmaker: Repeal of medical device tax could come with Republican-led Congress
A good way to create jobs and stimulate the economy is to repeal the 2.3% medical device tax, and it's a move that has ...Learn More
Industry exec commends proposed FDA oversight of LDTs
The FDA's proposed risk-based oversight of laboratory-developed tests would guarantee the effectiveness of the tests and ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, 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
Clarification
A summary in AdvaMed SmartBrief on Wednesday should have said Lantheus Medical Imaging postponed its plans for an initial ...Learn More
In helping others, we shall help ourselves, for whatever good we give out completes the circle and comes back to us.
Flora Edwards, American ...Learn More
Report: Medtech sector saw more but lower-value M&A deals in Q3
A PricewaterhouseCoopers report finds that the medical device sector signed 13 merger and acquisition deals during the third ...Learn More
IPO brings in nearly $145M for Nevro
Nevro, maker of the Senza spinal cord stimulation system, has obtained $144.9 million in an initial public offering. ...Learn More
Debt funding round nets $16M for Spiracur
Spiracur, the company behind the SnaP negative-pressure wound therapy device, has secured $16 million in debt financing from ...Learn More
Precision Therapeutics rebrands, appoints new execs
Cancer diagnostics firm Precision Therapeutics has pulled in $60 million through a financing round and adopted a new ...Learn More
Intarcia signs distribution deal with French firm Servier
Servier, a pharmaceutical company based in France, has struck a multimillion-dollar distribution deal with Intarcia ...Learn More
InGen to offer One Lambda's transplant Dx tests in France
One Lambda has renewed its distribution deal with InGen, an affiliate of Diaxonhit, for undisclosed terms. ...Learn More
Realizing the value of med-tech innovations
Why have med tech innovators been hesitant to bust through conventional device price ceilings and really go after the money ...Learn More
DNA test detects rejection risk in kidney transplant patients
Researchers at the University of California, San Francisco, and the University of Cincinnati have developed a genetic test ...Learn More
FDA clears Titan Spine's Endoskeleton implant line
The FDA has granted Titan Spine 510(k) clearance to market its Endoskeleton implant line, which features the firm's ...Learn More
Republican move to repeal device tax expected
The GOP's Senate majority win during last week's elections means Sen. ...Learn More
Vertebral body replacement device from K2M wins FDA nod
The CAPRI Corpectomy Cage System, developed by K2M, has obtained 510(k) clearance from the FDA. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 -- San Francisco, Calif. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It is not the mountain we conquer, but ourselves.
Edmund Hillary, New Zealand ...Learn More
Lantheus plans second IPO attempt
Lantheus Medical Imaging, which makes medical imaging isotopes, announced plans to file for an initial public offering, ...Learn More
Qiagen signs companion Dx deal with Novartis
Qiagen has agreed to work with Novartis to create and market companion diagnostics for the latter's current product line, as ...Learn More
IDT gains licensing rights to EliTech's qPCR probes
Integrated DNA Technologies will manufacture and offer EliTech's MGB Eclipse qPCR probes under a licensing deal reached ...Learn More
CytoSorbents enters partnership with global cardiac surgery company
An unnamed global cardiac surgery company has agreed to work with CytoSorbents to study the use of its CytoSorb cytokine ...Learn More
AdvaMed establishes new outpost in Shanghai
AdvaMed held a ceremony in Beijing to officially open its new office in Shanghai. ...Learn More
For more:
Read the AdvaMed press release about the opening of its representative office in Shanghai, ...Learn More
ViewRay's MRI-based radiotherapy device wins approval in Europe
An MRI-guided radiation therapy device developed by ViewRay has obtained CE mark approval in Europe. ...Learn More
Minimally invasive spinal implant market poised for growth in Latin America
The market for minimally invasive spinal implants in Latin America could be worth $60.7 million by 2019, a report from ...Learn More
New blood test checks for beta amyloid buildup
Scientists have created a blood test that assesses beta amyloid burden, and they believe it will aid research into the ...Learn More
FDA OKs spinal osteosynthesis rod from Medicrea
The FDA has given Medicrea Group 510(k) clearance to market its UNiD system, a spinal osteosynthesis rod that can be ...Learn More
Lombard's U.K. cleanroom facility gets FDA clearance
The FDA has cleared Lombard Medical to begin manufacturing Aorfix endovascular stent grafts at the firm's new cleanroom ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, 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
Progress lies not in enhancing what is, but in advancing toward what will be.
Kahlil Gibran, Lebanese artist, poet and ...Learn More
Medtronic signs loan package worth $16.3B
Medtronic has secured a loan package worth $16.3 billion, which the company said will be used to support its pending ...Learn More
IPO pulls in $19.1M for brain stimulation device firm
An initial public offering has brought in $19.1 million for Nexstim. ...Learn More
CareDx posts 16% year-over-year revenue increase in Q3
CareDx, which specializes in molecular diagnostics, reported a 16% year-over-year increase in its third-quarter revenues to ...Learn More
Japanese regulator approves MRI-safe ICD from Medtronic
The Japanese Ministry of Health, Labor and Welfare gave its approval to Medtronic's Evera MRI SureScan implantable cardiac ...Learn More
ACD enters partnership for RNAscope test development
Advanced Cell Diagnostics has struck a development deal with MicroMatrices for undisclosed terms. ...Learn More
Orthofix kicks off bone-stimulating device studies
Orthofix has begun its large-scale U.S. ...Learn More
Device sorts circulating tumor cells in the blood to predict spread of tumor
Scientists at the University of Toronto have designed a device that uses nanoparticles to sort circulating tumor cells into ...Learn More
Cervical plate from Zimmer Spine wins FDA nod
The FDA has granted 510(k) clearance for Zimmer Spine's Optio-C Anterior Cervical Plate, which is used in conjunction with ...Learn More
Guidance explaining molecular Dx device regulation issued by FDA
The FDA has issued guidelines governing the approval or clearance of certain molecular diagnostic systems. ...Learn More
ImThera gets FDA OK to launch trial of sleep apnea device
ImThera Medical has received approval from the FDA to conduct clinical trials of its aura6000, designed to treat obstructive ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 -- San Francisco, Calif. ...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
The excellence of a gift lies in its appropriateness rather than in its value.
Charles Dudley Warner, American ...Learn More
Funding round brings in $15M for OrthAlign
A round of financing headed by Mutual Capital Partners and River Cities Capital Funds has pulled in $15 million for ...Learn More
Report: Small bone orthopedics market could hit $4B by 2020
A report from iData projects that by 2020, the U.S. ...Learn More
Molecular Dx startup obtains $1.1M in financing
Prostate Management Diagnostics, a molecular diagnostics startup founded by the Peter Michael Foundation, has raised almost ...Learn More
CryoVascular signs distribution deal with Vascular Solutions
The PolarCath cryoplasty device, developed by Dr. ...Learn More
J&J, S. Korea collaborate to boost medtech industry
Johnson & Johnson Medical Korea and South Korea's Ministry of Health and Welfare have entered an agreement to invest $25 ...Learn More
German experts develop degradable orthopedic implants
Scientists from the Fraunhofer Institute for Manufacturing Technology and Advanced Materials in Germany have developed ...Learn More
DePuy Synthes launches hybrid arthroscopic anchor
The GRYPHON PROKNOT Anchor is available commercially, according to DePuy Synthes, a unit of Johnson & Johnson. ...Learn More
Aerocrine's device to treat asthma cleared by FDA
The FDA has cleared Aerocrine to market the Niox Vero system, which measures fractional exhaled nitric oxide in about a ...Learn More
FDA OKs SpineFrontier to develop advanced cervical spine implant
The FDA has granted SpineFrontier clearance for the Arena-C HA device, an intervertebral body fusion system intended to ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, 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
It's better to walk alone than with a crowd going in the wrong direction.
Diane Grant, Canadian playwright and ...Learn More


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In the News
West Michigan woman first in world to get life-saving heart device
By: MLive.com | February 2015

A West Michigan woman with heart disease became the first in the world to receive a new life-saving medical device, thanks to a “full court press” by Spectrum Health to get permission from federal regulators.

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Freedom Driver Allows Man With Artificial Heart to Await Transplant at Home
By: Gizmag | January 2015

Heart failure patients awaiting organ transplants normally find themselves anchored to the hospital bed by a washing machine-sized device that keeps blood pumping through their veins.

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New Medical Device Helps Local Man Survive
By: Brittni Smallwood | January 2015

At one time, Tom Desmond said only 25 percent of his heart worked. He said the left side was dead and the right side was struggling.

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Cutting-Edge Device Could Reverse Damage Caused by Heart Disease
By: James Walsh | November 2013

Sunshine Heart's C-Pulse device, which could reverse heart damage in some patients, has a potential worldwide market of up to $1 billion, an analyst says.

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