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Trial underway for Medtronic's stent graft system
A 140-patient clinical study has been launched by Medtronic to assess the effectiveness and safety of its Endurant Evo AAA, ...Learn More
IPO could pull in as much as $69M for Calif. surgical lighting firm
An initial public offering has been filed by Invuity with the goal of securing as much as $69 million. ...Learn More
Investor funding brings in $5M for Amarantus
Amarantus BioScience Holdings, which specializes in developing tests and treatments for ophthalmologic, psychiatric and ...Learn More
Voden Medical enters distribution partnership with Linkage Biosciences
Voden Medical Instruments has struck a deal to distribute Linkage Biosciences' genetic tests. ...Learn More
Covance acquisition drives Q1 revenue growth for LabCorp
Laboratory Corp. ...Learn More
Shoulder arthropathy device from FH Orthopedics gets FDA clearance
The Arrow, a reverse shoulder long keel glenoid base plate from French medtech firm FH Orthopedics, has received 510(k) ...Learn More
Raiing Medical unveils smartphone-connected thermometer
Raiing Medical has designed an adhesive temperature monitor and smartphone app that could be used by parents to monitor the ...Learn More
EU approves burn treatment tool from Avita Medical
European regulators have granted Avita Medical CE mark approval for its ReCell, a second-generation device intended for burn ...Learn More
Brazil OKs stent embolic protection technology from InspireMD
The MGuard Prime, a stent embolic protection device from InspireMD, has obtained approval from Brazilian regulators. ...Learn More
FDA labels Maquet's cardiac closure device recall as Class I
A recall involving Maquet Cardiovascular's TigerPaw II, a device intended to occlude the left atrial appendage of the heart ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
The world breaks everyone and afterward many are strong at the broken places.
Ernest Hemingway, ...Learn More
Senate proposal would expedite breakthrough medtech approval
A bill introduced by Sen. Richard Burr, R-N.C., would establish an FDA fast-track program for novel medical devices. ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl commending Sens. ...Learn More
Calif. firm takes in $3M in debt financing
A debt funding round has pulled in $3 million for Gynesonics. ...Learn More
Natera's blood-based prenatal test available in Canada
Natera has struck a deal with LifeLabs Medical Laboratory Services in which the lab will offer Natera's Panorama blood-based ...Learn More
Sanofi, Ypsomed enter injection system development deal
Ypsomed Group, a Swiss-based firm, has struck a deal to produce components for injection pens to be used in French drugmaker ...Learn More
Study shows positive results for Misonix's chronic wound device
Misonix's SonicOne OR, an ultrasonic debridement device, was associated with 42% less blood loss than standard debridement ...Learn More
Study to assess effectiveness of telerobotic ultrasound imaging technology
A study was launched by the Icahn School of Medicine at Mount Sinai with Rush University Medical Center to assess whether ...Learn More
VuCOMP seeks FDA approval for breast tomosynthesis software
VuCOMP is seeking premarket approval for its breast tomosynthesis computer-aided detection software. ...Learn More
Blood glucose monitor from Nipro Diagnostics gets FDA clearance
The True Metrix Air, a device developed by Nipro Diagnostics to read and evaluate blood glucose levels, has received 510(k) ...Learn More
FDA could approve Edwards Lifesciences' replacement heart valve in 2015
The Sapien 3 implant, a next-generation transcatheter aortic valve from Edwards Lifesciences, could get FDA approval this ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
The possible's slow fuse is lit by the imagination.
Emily Dickinson, ...Learn More
Senate subcommittee holds hearing on medical device tax
A hearing to consider repealing the 2.3% tax on medical devices was convened Thursday by the Senate Finance Committee's ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen Ubl on the Senate subcommittee hearing on possible repeal of the ...Learn More
Funding round brings in $18.5M for Spirox
Spirox has raised $18.5 million in a Series B financing round led by Aisling Capital and Venrock. ...Learn More
Maker of genetic tests enters distribution agreements in Thailand, Israel
Deals have been struck by Courtagen Life Sciences in Thailand and Israel for distribution of its next-generation sequencing ...Learn More
Developer of rapid blood assay receives $2.3M boost
Miroculus has secured $2.3 million in the first tranche of seed financing. ...Learn More
Clinical business drives Q1 revenue growth for Cepheid
Cepheid generated $132.6 million in revenue in the quarter ending March 31, up from $106.9 million generated in the same ...Learn More
Guidance for accepting medtech data from foreign trials unveiled by FDA
The FDA has issued guidelines on the criteria for accepting data from clinical trials conducted overseas for use in medtech ...Learn More
FDA clears digital radiography system from Rayence
The RU-3000, a universal digital radiography system from Rayence, has received 510(k) clearance from the FDA. ...Learn More
FDA OKs tomosynthesis option for Siemens Healthcare's mammography device
A digital breast tomosynthesis add-on to Siemens Healthcare’s Mammomat Inspiration technology has been approved by the ...Learn More
Interbody devices from Meditech Spine cleared by FDA
The next generation of Meditech Spine's Talos line of cervical intervertebral fusion devices has received 510(k) clearance ...Learn More
FDA approves prosthetic penile device from Coloplast
The FDA has granted Coloplast approval for the use of its Titan Inflatable Penile Prosthesis in ectopic reservoir placement. ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
Only a man who knows what it is like to be defeated can reach down to the bottom of his soul and come up with the extra ounce of power it takes to win when the match is even.
Muhammad Ali, ...Learn More
Some Biomet, Zimmer EU products to be acquired by Lima
A deal has been struck by Lima Corporate to acquire some products by Zimmer and Biomet in certain markets after the two ...Learn More
Collaboration aims to develop assays for immunity detection
Toronto-based molecular diagnostics firm Axela is partnering with Pathology Associates Medical Laboratories to develop ...Learn More
Biodesix's proteomic test scores reimbursement win from CareFirst
An agreement announced Wednesday between CareFirst Blue Cross Blue Shield and Biodesix will make Biodesix's VeriStrat ...Learn More
Q1 sales increase for Stryker
Stryker posted a 3.2% increase in consolidated net sales in the first quarter over the same period last year. ...Learn More
Green resigns CEO, president, board chair roles at Harvard Apparatus
David Green has stepped down as president, CEO and chairman of the board at Harvard Apparatus Regenerative Technology but ...Learn More
Drug-device combo targets prostate cancer
Swedish drugmaker LIDDS is negotiating with a manufacturer to produce a drug-device combination that could be a potential ...Learn More
Epilepsy device from Natus Medical cleared by FDA
The FDA has granted Natus Medical 510(k) clearance for its Quantum, an amplifier designed to monitor epilepsy and seizure. ...Learn More
EU expands approval for Medtronic's deep-brain stimulation tools
European regulators have given expanded approval to Medtronic to allow patients implanted with the company's MRI-safe Activa ...Learn More
Group B strep test from Great Basin Scientific scores FDA clearance
A molecular test developed by Great Basin Scientific for diagnosing group B streptococcus bacteria has received 510(k) ...Learn More
Agilent unit resolves issues at Danish plant
The FDA has issued a closeout letter clearing Dako Denmark, a unit of Agilent Technologies. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
He can who thinks he can, and he can't who thinks he can't. This is an inexorable, indisputable law.
Orison Marden, ...Learn More
Study underway for Medtronic's stent graft technology
A 24-patient feasibility study has been launched by Medtronic to assess the effectiveness and safety of its Valiant Mona, an ...Learn More
Boston firm gains $14M in Series B financing
A Series B funding round has brought in $14 million for Tal Medical. ...Learn More
Metamark's urology Dx tools score reimbursement win from Highmark Blue Shield
An agreement announced Tuesday between Highmark Blue Shield and Metamark will make Metamark's prognostic and diagnostic ...Learn More
Sequencing products drive Q1 revenue growth for Illumina
Illumina generated $538.6 million in revenue in the first quarter, up from the $420.8 million generated in the same period ...Learn More
Vietnamese installation of linear accelerator reported by Varian
Vinmec International Hospital in Vietnam has installed a unit of Varian Medical Systems' Clinac iX, a medical linear ...Learn More
Report: Worldwide orthobiologics market could reach $7.9B by 2019
A MicroMarketMonitor report predicts the worldwide market for orthobiologics will hit $7.9 billion by 2019, with a 6.7% ...Learn More
EU approves 4 Dx tests from Invivoscribe
European regulators have granted Invivoscribe Technologies CE mark approval for its four LymphoTrack Dx next-generation ...Learn More
Alcyone Lifesciences' neuro-ventricular device cleared by FDA
The FDA has granted Alcyone Lifesciences 510(k) clearance for its MEMS Cannula, a neuro-ventricular system designed to treat ...Learn More
FDA clears smaller Diamondback 360 system from Cardiovascular Systems
A smaller version of Cardiovascular Systems' Diamondback 360, a technology designed to treat peripheral artery disease, has ...Learn More
Aneurysm device recommendations released by FDA panel
Recommendations including five years of postmarket monitoring and one year of premarket study have been issued by the FDA's ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Every man must do two things alone: He must do his own believing and his own dying.
Martin Luther, ...Learn More
St. Jude Medical to buy Spinal Modulation for $175M
St. ...Learn More
Baltimore medtech firm takes in over $2.9M in debt financing
A debt funding round involving some 30 investors has pulled in more than $2.9 million for CSA Medical. ...Learn More
Molecular Dx firm enters distribution deals in Middle East, Italy
Curetis, a German molecular diagnostics company, has struck distribution deals in the Middle East and Italy for its Unyvero, ...Learn More
Hurel enters partnership with Optivia Biotechnology
Hurel, a North Brunswick, N.J., cell-based test company, has entered into a marketing and technology collaboration with ...Learn More
Getinge's sales rise in Q1
Getinge posted a 19% increase in year-over-year sales in the first quarter, bringing in $775 million. ...Learn More
EU patent covering silver coating system issued to aap Implantate
A European patent has been secured by aap Implantate for its silver coating technology designed for medical implants as well ...Learn More
Emergency cannula from CardiacAssist approved by EU
European regulators have granted CardiacAssist CE mark approval for its PROTEK Duo, a minimally invasive emergency cannula ...Learn More
House bill would roll back medical device tax
Rep. Alma Adams, D-N.C., has introduced a bill that would repeal the 2.3% excise tax on medical devices. ...Learn More
FDA approves 2 defibrillators from Biotronik
The FDA has granted Biotronik approval for its Inventra DX, an implantable, ultra-high-energy cardioverter defibrillator. ...Learn More
U.S., Canadian regulators approve picosecond laser for treating pigmented lesions
The FDA has granted Syneron Candela expanded approval for its PicoWay, a picosecond laser previously approved for use in ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22 | Washington, D.C. ...Learn More
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va. ...Learn More
We all need people who will give us feedback. That's how we improve.
Bill Gates, businessman and ...Learn More
Trial underway for Boston Scientific's renal denervation device
A 100-patient, multisite study has been launched by Boston Scientific to test the efficacy of Vessix, its renal denervation ...Learn More
Avera Health, Theranostics expand proteomic panel deal
Theranostics Health has entered into an expanded commercial and development deal with South Dakota-based Avera Health for ...Learn More
University enters colon cancer Dx technology deal with DiaCarta
The University of Potsdam in Germany has agreed to license its noninvasive method of diagnosing colon cancer to Hayward, ...Learn More
OpGen appoints 2 new execs
Kevin Krenitsky, who previously served as chief commercial officer at Foundation Medicine, has been tapped to serve as ...Learn More
Arteriovenous graft from Vascular Flow shows positive results in trial
A European study showed promising results for Vascular Flow Technologies' Spiral Flow, an arteriovenous graft that copies ...Learn More
Sunshine Heart asked to adjust protocol for heart device trial
The FDA has asked Sunshine Heart to make changes to its protocols for the multisite study of its C-Pulse, a heart failure ...Learn More
Cell-based analysis system from Fluxion debuts in U.S.
The IsoFlux EMT enrichment system, an instrument designed to separate rare circulating tumor cells from samples of blood, ...Learn More
Taiwan to implement changes to medtech registration, approval
Changes to the registration and approval of medtech products are to be enforced by Taiwanese regulators starting July 1. ...Learn More
Presbyopia device from AcuFocus lands FDA nod
The Kamra inlay system, a corneal implant developed by AcuFocus to enhance vision in patients suffering from presbyopia, has ...Learn More
Abbott's OTC glucose monitor approved by FDA
The FDA has granted Abbott Laboratories approval for its FreeStyle Precision Neo, an over-the-counter tool designed to ...Learn More
Supplier Controls: Regulations and Best Practices
June 17 | VirtualCan't travel? Learn from FDA (invited) and industry experts during this daylong virtual workshop. ...Learn More
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and ...Learn More
There's only one corner of the universe you can be certain of improving, and that's your own self.
Aldous Huxley, ...Learn More
Sanford Health signs stent graft technology deal with Medtronic
Sanford Health has agreed to license its stent graft system, a technology that treats thoracoabdominal aortic aneurysms, to ...Learn More
Funding round pulls in $9.6M for Ortho Kinematics
A Series C equity funding round has brought in $9.6 million for health care diagnostics firm Ortho Kinematics. ...Learn More
Masimo's oximetry tool to be part of CapsuleTech's patient monitoring system
A partnership was formed between CapsuleTech and Masimo to incorporate the latter's SET Measure-through Motion and Low ...Learn More
Q4 revenue increases for Transgenomic
Transgenomic generated $7.7 million in revenue in the quarter ending Dec. ...Learn More
Researchers working on cellphone-based malaria diagnostics
A rapid-response, cellphone-based diagnostic test for malaria is being developed by researchers from Michigan State ...Learn More
SpineFrontier's device used in anterior cervical disc fusion in Va.
A patient with cervical stenosis and cervical spinal spondylolis at Newport News-based Bon Secours Mary Immaculate Hospital ...Learn More
Group A strep test from Focus Diagnostics scores FDA clearance
The Simplexa Group A Strep Direct, a PCR test developed by Focus Diagnostics, received 510(k) clearance from the FDA. ...Learn More
EU approves HIV-1 assay from Cepheid
The Xpert HIV-1 Qual, a qualitative HIV-1 test developed by Cepheid for early diagnosis in infants and individuals who are ...Learn More
CAS Medical Systems gains expanded FDA approval for oximeter
The FDA has granted CAS Medical Systems expanded labeling approval for its Fore-Sight Elite tissue oximeter to include ...Learn More
Cervical cancer test from Cancer Genetics lands conditional OK in N.Y.
The New York State Department of Health has given Cancer Genetics conditional licensure to expand its push for wider use of ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
If you are irritated by every rub, how will your mirror be polished?
Rumi, poet and ...Learn More
Ortho Kinematics gains nearly $10M in Series C financing
Austin, Texas-based Ortho Kinematics has obtained almost $10 million in a Series C funding round that includes Medtronic as ...Learn More
Novation enters group purchasing deal with RTI Surgical
Novation, a health care group purchasing organization, has struck a deal giving its more than 100,000 members access to RTI ...Learn More
Frankenman, Boston Scientific enter endoscopic products development deal
Boston Scientific said it has struck a strategic partnership with Frankenman Medical Equipment to develop and produce ...Learn More
Analysis: U.S. market for biocompatible materials to hit $5.5B in 2018
An analysis by ReportBuyer predicts the biocompatible materials market in the U.S. ...Learn More
Nihon Kohden America appoints new CEO
Dr. Constantine Wilson has been promoted from chief operating officer to CEO of Irvine, Calif.-based Nihon Kohden America. ...Learn More
Shoulder fracture cage from Conventus scores FDA clearance
The PH Cage, a shoulder fracture cage developed by Conventus Orthopaedics that expands within the bone, has received 510(k) ...Learn More
BioFire files de novo submission for encephalitis, meningitis Dx panel
BioMerieux unit BioFire has filed a de novo submission with the FDA for its FilmArray Meningitis/Encephalitis Panel. ...Learn More
EU approves robotic PAD catheter from Hansen
European regulators have granted Hansen Medical CE mark approval for its 10-French Magellan, a robotic catheter designed to ...Learn More
EU approves HCV viral load test from Cepheid
The Xpert HCV Viral Load, a test developed by Cepheid to confirm and monitor hepatitis C virus infection, has received the ...Learn More
Perseon gains expanded FDA approval for ablation device
The FDA has granted Perseon expanded approval for its MicroThermX microwave ablation technology, which previously was ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Fear defeats more people than any other one thing in the world.
Ralph Waldo Emerson, ...Learn More
Cyberonics-Sorin deal approved by U.S. regulators
The pending all-stock merger of Cyberonics with Italy's Sorin Group for $1.4 billion has received approval from antitrust ...Learn More
Termination date for Zimmer-Biomet deal extended to July 23
The termination date for Zimmer Holdings' pending merger with Biomet for $13.4 billion has been moved from April 24 to July ...Learn More
Funding round brings in $3.3M for U.K.-based firm
A Series A financing round pulled in $3.3 million for Congenica. ...Learn More
Equity funding round pulls in $2.3M for Novacyt
A private equity placement brought in $2.3 million for Paris-based Novacyt. ...Learn More
Certified public accountant named CFO of Tegra Medical
Craig Campbell, a certified public accountant with almost 25 years of finance and accounting experience, was tapped to serve ...Learn More
Helius gets FDA nod to begin trial enrollment for brain stimulator device
The FDA has given Helius Medical approval to enroll patients with chronic balance problems caused by mild to moderate injury ...Learn More
Anterior lumbar retractor from TeDan Surgical debuts in U.S.
The Phantom AL Retractor System, a device intended to provide better visualization during anterior lumbar interbody fusion ...Learn More
EU approves transcatheter pacing technology from Medtronic
European regulators have granted Medtronic CE mark approval for its Micra device, a leadless transcatheter pacing system. ...Learn More
IDE application for bone scaffold submitted by Anika Therapeutics
An investigational device exemption application has been filed with the FDA by Anika Therapeutics to begin a late-stage ...Learn More
Waters instrument approved for in vitro Dx use in China
Waters' Acquity UPLC I-Class IVD/Xevo TQ-S IVD LC-MS technology was approved by China's Food and Drug Administration for use ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Have patience. All things are difficult before they become easy.
Saadi, ...Learn More
J&J unit, Ichor Medical collaborate on hepatitis B drug-device combo
San Diego-based Ichor Medical Systems has entered into a licensing and development deal with Janssen Pharmaceuticals, a unit ...Learn More
Funding round brings in $15M for ReCor Medical
A Series D financing round led by Otsuka Holdings pulled in $15 million for ReCor Medical. ...Learn More
Funding round brings in $1.5M for Israel-based firm
A funding round pulled in $1.5 million for Leviticus Cardio. ...Learn More
Maker of cancer-screening technology bought by Roche
Roche Holding has agreed to pay an undisclosed sum to buy CAPP Medical, a California-based firm that has developed a system ...Learn More
Firm wins $1.5M grant for HIV/AIDS assay
The NIH awarded Rheonix a phase II grant worth $1.5 million under its Small Business Innovation Research program to continue ...Learn More
EverGene, Affymetrix to team up in genotyping service deal in Japan
A deal was reached between Affymetrix and EverGene to cooperate on a personal genomics service in Japan. ...Learn More
Bone fracture device from IlluminOss shows positive results in study
Research in the Journal of Biomedical Materials Research Part B: Applied Biomaterials showed promising results for ...Learn More
Smartphone-enabled device shows promise in detecting cancer
A study in the Proceedings of the National Academy of Sciences describes a device that could be used along with smartphones ...Learn More
FDA grants breakthrough status to peanut allergy patch
The Viaskin Peanut, an electrostatic patch developed by DBV Technologies, has obtained breakthrough designation as a ...Learn More
FDA labels Intuitive Surgical's drapes recall as Class II
A recall initiated by Intuitive Surgical involving about 440,000 Microtek Medical drapes has been labeled Class II by the ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Vanity and pride are different things, though the words are often used synonymously. A person may be proud without being vain. Pride relates more to our opinion of ourselves, vanity to what we would have others think of us.
Jane Austen, ...Learn More
Funding round brings in $20M for EBR Systems
A financing round involving former Medtronic executive Stephen Mahle has pulled in $20 million for EBR Systems. ...Learn More
AngioDynamics gains license for EmboMedics' microspheres
EmboMedics has agreed to license its resorbable microspheres to AndioDynamics, a Latham, N.Y.-based firm, for $11 million. ...Learn More
Improved sales productivity drives Q1 revenue growth for Bacterin
Bacterin generated between $9.4 million and $9.5 million in total net revenue in the first quarter, a 5% to 7% increase over ...Learn More
Q4 sales jump for molecular imaging firm
Advanced Accelerator Applications generated $24.6 million in sales for the fourth quarter of 2014, compared with $18.6 ...Learn More
Finance veteran named CFO of Cepheid
Ilan Daskal, who has over 20 years of experience in finance, has been tapped to serve as the CFO of Cepheid. ...Learn More
Trial enrollment for Vertos Medical's back pain treatment completed
Vertos Medical has completed patient enrollment for a multisite, randomized and controlled trial of its minimally invasive ...Learn More
HemCon wins approval for wound care products in China
Chinese regulators have granted Portland, Ore.-based HemCon Medical Technologies approval to market its entire wound care ...Learn More
Senate hearings on repealing medical device tax planned
Hearings on repealing the 2.3% tax on medical devices could happen in the Senate Finance Committee in the near future. ...Learn More
FDA approves study of CardiAQ's mitral valve implant
CardiAQ Valve Technologies has received an investigational device exemption from the FDA to conduct an early feasibility ...Learn More
Medtech price control order endorsed in India
India's Task Force on Medical Devices has endorsed the inclusion of medical devices in the Essential Commodities Act and ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Iron rusts from disuse; water loses its purity from stagnation ... even so does inaction sap the vigor of the mind.
Leonardo da Vinci, artist and ...Learn More
Final guidance for expedited medtech approval unveiled by FDA
The FDA has issued final guidelines on policies designed to expedite the approval of medtech products for irreversibly ...Learn More
Molecular Dx lab acquired by Rosetta in $2M deal
Rosetta has agreed to pay $2 million in cash plus 500,000 ordinary shares to buy PersonalizeDx, a molecular diagnostics ...Learn More
Report: Orthobiologics market in North America to reach $2.4M by 2019
A MicroMarketMonitor report predicts the North American market for orthobiologics will hit $2.4 million by 2019, with a 7.7% ...Learn More
Q1 revenue increases for SpineGuard
SpineGuard posted a 47% increase in year-over-year revenue during the first quarter, driven by the higher sales of its ...Learn More
Company veteran named chief scientific officer of Osiris
Alla Danilkovitch has been appointed chief scientific officer of Osiris Therapeutics, a company focused on regenerative ...Learn More
FDA clears IV monitoring tool from Va. firm
The FDA has given ivWatch 510(k) clearance to market the ivWatch Model 400, a device that can spot adverse extravasation and ...Learn More
Directional atherectomy tool from Medtronic debuts in U.S.
The HawkOne, a directional atherectomy system developed to address extremely calcified lesions in lower extremities' blood ...Learn More
Firm seeks humanitarian exemption for biofiltration system
The FDA has been asked by Aethlon Medical to grant its Hemopurifier biofiltration system a humanitarian device exemption ...Learn More
EU approves Sophia Genetics' tool to detect BRCA gene variations
European regulators have granted Sophia Genetics the CE-IVD mark for its device that can diagnose copy number variations in ...Learn More
Canada approves heart pump from HeartWare
Health Canada has given Massachusetts-based HeartWare the go-ahead to market its implantable left ventricular assist device ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Each man must look to himself to teach him the meaning of life. It is not something discovered; it is something molded.
Antoine de Saint-Exupery, ...Learn More
Stakeholders debate merits of speeding up regulatory review of devices, drugs
Former FDA Commissioner Margaret Hamburg has raised concerns about congressional efforts to speed up the drug and medical ...Learn More
Debt funding round nets $7.5M for DxTerity
Debt financing from SWK Funding will bring in as much as $7.5 million for DxTerity Diagnostics. ...Learn More
Atlas eyes $5M in financing to monetize spinal implant systems
Atlas Spine is hoping to raise $5 million in a Series B funding round involving OfferBoard Securities. ...Learn More
Microbiome, Biocartis team up in rapid blood assay deal
A global partnership deal was reached between Microbiome and Biocartis to develop a polymerase chain reaction-based rapid ...Learn More
2 Japanese medtech firms widen gastroenterology, urology deal in U.S.
Japanese device-makers Olympus and Terumo have completed a deal to broaden their business partnership in the U.S. ...Learn More
DARPA backs development of blood-sampling device
The Defense Advanced Research Projects Agency awarded Tasso and its partner GenTegra a grant worth $2.9 million to advance ...Learn More
Biotronik records first U.S. patient implanted with pacemaker system
A patient at Lenox Hill Hospital in New York was the first in the U.S. ...Learn More
FDA OKs diabetic retinal screening software
Intelligent Retinal Imaging Systems, software that is used for retinal screening, has obtained FDA clearance to screen for ...Learn More
Surgical navigation tool from Synaptive Medical scores FDA clearance
The FDA has granted Synaptive Medical clearance for its BrightMatter Guide, a surgical navigation system for use during ...Learn More
Ablation tool from Perseon gets FDA nod
The MicroThermX, a microwave ablation device from Perseon, has received 510(k) clearance from the FDA. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Never be bullied into silence. Never allow yourself to be made a victim. Accept no one's definition of your life; define yourself.
Harvey Fierstein, actor and ...Learn More
Trial underway for Medtronic's ablation device
A one-year, 1,000-patient registry study was launched by Medtronic to test the use of its Gold device, a pulmonary vein ...Learn More
Equity funding round pulls in more than $5M for Minn. firm
A private equity offering has brought in over $5 million for Pursuit Vascular, according to a recent regulatory filing. ...Learn More
N.J. molecular Dx firm obtains funding boost
A Series A funding round led by Prime Value Capital Management has brought in an undisclosed sum for Admera Health. ...Learn More
South Korean firm launches U.S. division in Calif.
Seegene Technologies, the U.S. subsidiary of South Korean firm Seegene, has opened in Concord, Calif. ...Learn More
Study to look at health care apps and devices for seniors
AARP announced plans to collaborate with Pfizer and UnitedHealthcare on an initiative to determine how people ages 50 and ...Learn More
Video system monitors vital signs using skin color changes
Rice University researchers have developed DistancePPG, a video system to measure pulse and breathing rate by analyzing ...Learn More
Advanced Breath Diagnostics' gastroparesis test lands FDA nod
The FDA has granted Brentwood, Tenn.-based Advanced Breath Diagnostics approval to market its Gastric Emptying Breath Test, ...Learn More
ReShape allowed to bypass FDA advisory panel meeting for weight-loss device
A requirement that would have ReShape Medical attend an advisory committee meeting for the premarket approval filing of its ...Learn More
Hospira receives FDA warning over manufacturing practices at Italian plant
The FDA has issued a warning letter to Hospira over manufacturing practice violations at its facility in Liscate, Italy. ...Learn More
FDA labels Zimmer's knee implant recall as Class II
A recall initiated by Zimmer involving 11,658 Persona Trabecular Metal Tibial Plate knee implants has been labeled Class II ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Indecision and delay are the parents of failure.
George Canning, ...Learn More
Funding round brings in $55.5M for Natera
Natera has obtained $55.5 million in a private financing round led by Sofinnova Ventures. ...Learn More
IPO could pull in up to $35.2M for microbial genetics analysis firm
OpGen filed plans Monday with the U.S. ...Learn More
Dentistry school receives grant to develop test for HIV antibodies, viral RNA
Researchers from New York University College of Dentistry have been awarded a $335,000 grant from the National Institutes of ...Learn More
Report: Worldwide nonfusion spinal device market poised for growth
A Medical Market Research report forecasts the worldwide market for nonfusion spinal devices will grow through 2019. ...Learn More
Cogentix to move production facility to Westborough, Mass.
Cogentix Medical said it intends to transfer its manufacturing plant in Natick, Mass., to a 24,400-square-foot facility in ...Learn More
U.S. patent covering bone matrixes issued to Bacterin
Bacterin has secured a U.S. patent for some demineralized bone matrixes in its OsteoSponge devices. ...Learn More
FDA clears surgical hydrogel from Augmenix
The FDA has granted Augmenix clearance for its SpaceOAR hydrogel system under the agency's de novo program. ...Learn More
Ethicon gains expanded FDA approval for surgical sealant patch
The FDA has granted Ethicon expanded approval for its Evarrest, a fibrin sealant patch previously approved as an adjunct ...Learn More
Blood glucose monitor from Abbott approved by Indian regulators
Indian regulators have granted Abbott approval for its FreeStyle Libre Pro Flash, a wearable sensor device that can monitor ...Learn More
China clears Cytori to market regenerative cell technology
Cytori Therapeutics' Celution System has obtained clearance from Chinese regulators. ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
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Just remember, once you're over the hill you begin to pick up speed.
Charles Schulz, ...Learn More
Medtronic reports positive trial results for peripheral stent
A 287-patient, three-year multisite study showed promising results for Medtronic's EverFlex, a self-expanding nitinol stent ...Learn More
Medtronic gains license for artificial pancreas technology
DreaMed Diabetes, a medtech firm in Israel, has agreed to license its GlucoSitter artificial pancreas system to Medtronic. ...Learn More
Former Hologic executive joins Royal Philips as global imaging CEO
Rob Cascella has been tapped to serve as CEO of Royal Philips' global diagnostic imaging business. ...Learn More
World Institute of Pain founder named to Stimwave's medical advisory board
Dr. ...Learn More
Wearable defibrillator from Zoll shows positive results in study
A study in the journal Heart Rhythm showed promising results for Zoll Medical's LifeVest, a cost-effective, wearable ...Learn More
Immunexpress develops rapid diagnostic test for sepsis
Immunexpress has developed a diagnostic tool that can screen for sepsis in just an hour. ...Learn More
Idaho firm designs smartphone-based autism diagnosis tool
Behavior Imaging's new app, Naturalistic Observation Diagnostic Assessment, can speed up the diagnosis of children who are ...Learn More
Microbial ID tool from Bruker scores FDA clearance
An expanded variant of the MALDI Biotyper, a clinical microbiology technology developed by Bruker, has received 510(k) ...Learn More
Medtronic agrees to pay $4.4M to settle spinal surgery device lawsuit
Medtronic has reached a $4.4 million settlement deal with the federal government to resolve a lawsuit accusing the firm of ...Learn More
FDA labels Philips' CT scanner recall as Class II
A recall initiated by Philips Healthcare involving 424 CT scanners has been labeled as Class II by the FDA. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
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Ill habits gather by unseen degrees, as brooks make rivers, rivers run to seas.
Ovid, ...Learn More
Dutch diabetes clinic and research center acquired by Medtronic
Medtronic has purchased Diabeter, a Dutch clinic and research facility for diabetes patients, for undisclosed terms. ...Learn More
Roche's bid to buy majority stake in cancer Dx firm gets shareholder OK
Roche's plan to acquire a majority stake in Foundation Medicine, a cancer molecular diagnostics company based in Cambridge, ...Learn More
Miracor widens U.K. presence with new sales office, 2 heart device trials
Miracor Medical Systems, the Austrian maker of the PICSO impulse system, has opened a new sales unit in Manchester, England. ...Learn More
Firm wins $1.5M grant for antibiotic-resistant TB test
The NIH awarded InSilixa a phase II grant worth $1.5 million under its Small Business Innovation Research program for the ...Learn More
Report: Surgical microscope market to hit $806.6M by 2020
A MarketsandMarkets report predicts the market for surgical microscopes will be worth $806.6 million by 2020, with a ...Learn More
Report: Worldwide hip implant market poised for growth
A Medical Market Research report forecasts the worldwide hip implant market will see a 2.98% compound annual growth rate ...Learn More
FDA expands approval of AirStrip fetal, maternal monitoring kit
A second FDA clearance was granted to AirStrip for its wireless maternal and fetal monitoring kit, Sense4Baby. ...Learn More
Group A strep test from Alere scores FDA clearance
The i Strep A molecular test, developed by Alere, has received 510(k) clearance from the FDA. ...Learn More
Heart valve from On-X Life gets OK on expanded label from FDA
The FDA has granted On-X Life Technologies expanded labeling approval for its aortic heart valve to include reduced ...Learn More
EU approves home dialysis system from Baxter
European regulators have granted Baxter International CE mark approval for its HomeChoice Claria, a home peritoneal dialysis ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Honest disagreement is often a good sign of progress.
Mahatma Gandhi, social ...Learn More
Maker of biliary devices acquired by Boston Scientific in $62.5M deal
Boston Scientific has agreed to pay $62.5 million upfront to acquire Mountain View, Calif.-based Xlumena and its Hot Axios ...Learn More
Vision-Sciences concludes merger with Uroplasty to form Cogentix
The merger combining Vision-Sciences and Uroplasty into Cogentix Medical was completed Wednesday. ...Learn More
Deal gives Orthofix option to buy migraine-device firm
Orthofix has struck a deal that includes an 18-month option to purchase eNeura and its SpringTMS, an FDA-approved device ...Learn More
Funding round brings in $3.4M for Boston-based Dx firm
A private placement pulled in $3.4 million for MetaStat. ...Learn More
Higher test volume drives Q4 revenue growth for GeneNews
GeneNews generated $557,457 in revenue in the quarter ending Dec. ...Learn More
Studies underway for Luminex's Aries diagnostic platform, HSV assay
Luminex has begun its clinical trials for the Aries molecular diagnostics system, a lower-throughput sample-to-answer ...Learn More
Bone fixation device from BioMedical Enterprises debuts
The Speed Titan, a nitinol-based bone fixation system, has been launched by BioMedical Enterprises. ...Learn More
FDA meeting to discuss computer modeling's use in medtech development
The use of computational modeling and simulation strategies in medical device evaluation and development will be discussed ...Learn More
Upgrades for Lensar's cataract laser device cleared by FDA
Streamline, the collective name for Lensar's five new application technologies for its Lensar Laser System, has received ...Learn More
New York Genome Center gets OK to offer clinical exome tests in state
The New York State Department of Health has granted the New York Genome Center approval to offer its clinical exome test in ...Learn More
Adaptive Designs: Overview, Hurdles & Examples
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
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Attach yourself to those who advise you rather than praise you.
Nicolas Boileau-Despreaux, poet and literary ...Learn More
Medtronic's heart valve obtains wider approval from FDA
The FDA has granted Medtronic expanded approval for use of its CoreValve system, a transcatheter aortic valve-replacement ...Learn More
DePuy gains exclusive rights to market Radlink's imaging system
A global sales deal has been struck between DePuy Synthes and Radlink to allow DePuy to exclusively market Radlink's Galileo ...Learn More
Quest Diagnostics forms joint venture with contract research firm
A joint venture was formed that will merge the clinical trial laboratory businesses of Quest Diagnostics and Quintiles ...Learn More
Stryker to build center of excellence in Ireland
Stryker is planning to set up an international center of excellence in Cork, Ireland. ...Learn More
Q3 net sales show growth for Orthofix
Orthofix generated $101 million in net sales during the company's fiscal year 2014 third quarter, which is an increase of ...Learn More
Former executive at Analogic joins Insulet as CFO
Michael Levitz has been tapped to serve as chief financial officer at Insulet. ...Learn More
Hansen enters partnership with China National Medical Device
Hansen Medical has entered into a distribution deal with China National Medical Device for its Magellan surgical robot ...Learn More
Tenn. firm enters distribution deals with 25-plus global partners
Knoxville, Tenn., firm EDP Biotech has struck deals with over 25 distribution partners in South America, Asia and Europe ...Learn More
SynCardia gets FDA OK to launch study of heart failure device
SynCardia Systems has received an investigational device exemption from the FDA to conduct a trial to evaluate the use of ...Learn More
China clears Hangzhou Berry Genomics to market prenatal test
The NextSeq CN500, a noninvasive prenatal test developed by Hangzhou Berry Genomics, has obtained premarket clearance from ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
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See AdvaMed-MTLI's schedule of courses
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To praise is an investment in happiness.
George Adams, newspaper ...Learn More
Zimmer-Biomet deal approved by EU regulators
The pending merger of Zimmer Holdings with Biomet for $13 billion has received approval from antitrust regulators in Europe. ...Learn More
Merger of Vision-Sciences, Uroplasty gets shareholder approval
Shareholders approved an all-stock merger combining Uroplasty and Vision-Sciences into Cogentix Medical. ...Learn More
Exact Sciences' colorectal cancer test scores reimbursement win from Tufts Health
The use of Exact Sciences' Cologuard, a noninvasive stool-based test that screens for colorectal cancer markers, will be ...Learn More
Funding round brings in nearly $1.27M for Saphena Medical
Saphena Medical has raised almost $1.27 million via a Series B preferred stock sale, bringing the company closer to its $3 ...Learn More
Novation enters group purchasing deal with Benvenue
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External fixation device from Zimmer debuts in U.S.
The XtraFix, a modular instrument that facilitates external fixation procedures, was launched by Zimmer. ...Learn More
D-Eye unveils smartphone-connected retinal imaging device
D-Eye has unveiled a new system designed to be affixed to a smartphone to capture high-resolution retinal images and videos. ...Learn More
Insulin management system from Medtronic approved in U.K.
The U.K. ...Learn More
Mass spectrometry tool from Thermo Fisher submitted to FDA as Class I device
The Prelude LX-4 MD HPLC, a mass spectrometry instrument, has been registered by Thermo Fisher Scientific with the FDA as a ...Learn More
Heart valve from Medtronic wins approval in Japan
Japanese regulators have given Medtronic approval to market its CoreValve, a transcatheter aortic valve-replacement device, ...Learn More
FDA Submissions Strategy Workshop
June 23-24AdvaMed office, Washington, D.C.This two-day workshop is designed to prepare you for the development and execution ...Learn More
Advertising and Promotion of Medical Devices
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The most common way people give up their power is by thinking they don't have any.
Alice Walker, ...Learn More
Pentagon extends supply contract with Royal Philips for $77.2M
The Defense Department has renewed its contract with Royal Philips for the sixth one-year option on a nine-year deal, for an ...Learn More
J&J partners with Google to develop surgical robots
Google and Johnson & Johnson have agreed to team up on the creation of a robotic surgical platform that combines ...Learn More
Funding round brings in $3.25M for surgical mesh maker
Kips Bay Medical has obtained $3.25 million in a private placement that includes its founder, Manny Villafana, as an ...Learn More
Veracyte, Sanofi firm enter marketing deal for gene expression test
Genzyme, a Sanofi firm, struck a five-year deal that started Jan. ...Learn More
Venture capitalist named to Avedro's board
David McIntyre, a partner in the health care venture capital firm Apple Tree Partners, has been tapped to serve on the board ...Learn More
Pivotal study begins for Obalon's weight-loss device in U.S.
Obalon Therapeutics has started a set of pivotal studies to test the use of its ingestible gas-filled balloon in losing ...Learn More
Bioness tests neuromodulation device for overactive bladder
Bioness has kicked off a six-month study in Canada that aims to test its minimally invasive StimRouter Neuromodulation ...Learn More
Fetal micro-pacemaker lands humanitarian exemption from FDA
The FDA has granted a humanitarian device exemption approval for a fully implantable fetal micro-pacemaker designed by ...Learn More
Voyant receives FDA OK for TraumaCad Mobile tool
Voyant Health has obtained FDA clearance to market the mobile version of its TraumaCad solution. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
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Technical Writing for Regulatory Submissions
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You are surrounded by hundreds of people more timid than you are.
Fred Barton, ...Learn More
Colo.-based maker of hearing aid implants acquired by Medtronic
Medtronic has concluded the purchase of Sophono, a Boulder, Colo.-based maker of magnetic hearing aid implants, for ...Learn More
Radlink signs hip imaging deal with J&J unit
Radlink has agreed to license its Galileo positioning system to DePuy Synthes, a Johnson & Johnson unit. ...Learn More
Medtech startup pulls in $1.52M from funding round
An ongoing financing round being led by Cultivation Capital has brought in $1.52 million for Cardialen. ...Learn More
Atlas technology drives Q4 revenue growth for Roka Bioscience
Roka Bioscience generated $1.4 million in revenue in the quarter ending Dec. ...Learn More
ISO certification granted to MolecularMD's quality management system
The British Standards Institution has granted MolecularMD certification for the company's quality management system for its ...Learn More
Advanced bone matrix from Stryker debuts in U.S.
The BIO4, a viable bone matrix with endogenous bone-forming cells, is being launched by Stryker at the American Academy of ...Learn More
FDA clears external fixation technology from Wright Medical
The Salvation, an external fixation system developed by Wright Medical for ankle and foot surgeries, has received 510(k) ...Learn More
Stryker's spinal repair device cleared by FDA
The FDA has given Stryker 510(k) clearance to market the Lite Plate System, a lateral and anterior lumbar plate technology ...Learn More
EU approves biotherapy monitoring tool from Theradiag
European regulators have granted Theradiag, a French diagnostics firm, CE mark approval for its Stelara biotherapy ...Learn More
Instructions for cleaning duodenoscopes released by Olympus
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Advertising and Promotion of Medical Devices
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See AdvaMed-MTLI's schedule of courses
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It's easy to have faith in people who have already proved themselves. It's much tougher to believe in people before they have proved themselves. But that is the key to motivating people to reach their potential.
John Maxwell, writer and motivational ...Learn More
Zimmer-Biomet deal approved by Japanese regulators
The pending merger of Zimmer with Biomet for $13.35 billion has received approval from antitrust regulators in Japan. ...Learn More
Maker of cell therapy device for diabetes gains $44M in Series A financing
Semma Therapeutics has obtained $44 million in a Series A funding round that includes Medtronic as an investor. ...Learn More
Intellirod Spine gains rights to X-spine Systems' spinal implants
Licensing and distribution deals were struck between Intellirod Spine and X-spine Systems to give Intellirod the right to ...Learn More
Amgen, Dako expand collaboration on companion Dx development
Dako has entered into an expanded development deal with Amgen. ...Learn More
J&J unit, Royal Philips enter partnership for development of handheld blood test
Royal Philips has struck a development deal with Janssen Pharmaceutica, a unit of Johnson & Johnson. ...Learn More
Boston Scientific's anti-stroke device debuts in U.S.
Doctors at Cedars-Sinai Medical Center in Los Angeles and Providence Saint John's Health Center in Santa Monica, Calif., ...Learn More
Robot-assisted hip-replacement system from Stryker debuts in U.S.
A total hip arthroplasty tool for the Mako robotic surgical platform was launched by Stryker during a conference of the ...Learn More
Zyga records first commercial use of updated spine device in U.S.
A patient at Reno Orthopaedic Clinic in Nevada was the first to undergo surgery using Zyga Technology's updated SImmetry ...Learn More
FDA clears spinal fixation technology from K2M
The NILE Alternative Fixation Spinal System, developed by K2M, has received 510(k) clearance from the FDA. ...Learn More
Vital Art and Science receives second FDA clearance for vision test
A second FDA clearance was granted to Vital Art and Science for its smartphone eye test application called myVisionTrack. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Never interrupt someone doing something you said couldn't be done.
Amelia Earhart, ...Learn More
Funding round brings in $11M for Osprey Medical
A private placement pulled in $11 million for Osprey Medical. ...Learn More
Deal to give Global Enterprises majority stake in molecular Dx firm
A deal was struck Tuesday by diversified holding firm Global Enterprises Group to acquire a majority stake in Predictive ...Learn More
Fund to support medtech, other life-science firms introduced in Poland
The Joint Polish Investment Fund I, a venture capital fund devoted to investments in life-science companies, has been ...Learn More
Teleflex records first surgery using percutaneous surgical system
A patient at the Cleveland Clinic was the first to undergo a procedure using Teleflex's Percuvance Percutaneous Surgical ...Learn More
Carestream partners with medical specialists to develop 3D extremity-imaging device
A 3D conebeam CT scanner for extremities is being developed by Carestream Health in collaboration with specialists in ...Learn More
Virtual-reality platform from EchoPixel debuts in U.S.
The True3D Viewer, a platform that can change anatomical data into virtual-reality images, was launched by EchoPixel. ...Learn More
Production milestone hit by Vistek Medical for medtech components
Vistek Medical has produced 2 million medical components and implants, which is a production milestone for the company. ...Learn More
Proposal to repeal medical device tax introduced in Senate
A bill that would repeal the 2.3% excise tax on medical devices and increase taxes on oil and gas companies to replace the ...Learn More
Rapid Ebola test from Cepheid receives FDA approval for emergency use
Cepheid's Xpert Ebola, a PCR-based test for the Ebola virus, has been given authorization for emergency use by the FDA. ...Learn More
N.J. approves use of 2 molecular Dx tests from Admera Health
The New Jersey Department of Health has approved the clinical use of Admera Health's OncoGxOne and PGxOne Plus ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
It does not matter how slowly you go as long as you do not stop.
Confucius, philosopher and ...Learn More
Abiomed's blood pump system lands FDA nod
The FDA has granted Abiomed approval to market its Impella 2.5 System, a miniature blood pump that preserves heart ...Learn More
Series C round pulls in $19M for OrthoSensor
OrthoSensor has obtained $19 million in a Series C financing round of preferred stock. ...Learn More
Simplify Medical acquired by Australian private-equity shop
M.H. ...Learn More
Former Qiagen Marseille managers set up new cancer Dx firm
The former executive management team of Qiagen Marseille has established HalioDx, an immuno-oncology diagnostics company, ...Learn More
Benvenue Medical announces new CFO
John Dahldorf has been appointed chief financial officer of Benvenue Medical, a maker of minimally invasive devices for ...Learn More
Diabetes technology improves, but patients still need support
Diabetes self-care has benefited from technologies such as the continuous glucose monitor, lancet-based glucose meters that ...Learn More
Cryoablation device from AtriCure being promoted for new indication
CryoIce, a cryoablation device from AtriCure, is being promoted for temporary relief of pain in cardiac and thoracic surgery ...Learn More
AdvaMed commends budget proposal that includes medical device tax repeal
A congressional budget resolution that includes language to repeal the 2.3% excise tax on medical devices was praised by ...Learn More
For more:
Read the entire statement from AdvaMed Senior Executive Vice President JC Scott about the possible repeal of the medical ...Learn More
Canada OKs next-generation sequencing system from Illumina
A medical device license was granted by Health Canada to Illumina's MiSeqDx tool, a next-generation sequencing system, ...Learn More
EU approves Oncomine fusion panel from Thermo Fisher
European regulators have granted Thermo Fisher Scientific the CE-IVD mark for its Oncomine Solid Tumor Fusion Transcript, a ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Our greatest weakness lies in giving up. The most certain way to succeed is always to try just one more time.
Thomas Edison, ...Learn More
Final guidance for reusable medtech product labeling, instructions unveiled by FDA
The FDA has issued final guidelines governing instructions and labeling for reusable medical devices, as well as guidelines ...Learn More
Drug-device combo maker sets IPO's midpoint price at $40M
SteadyMed Therapeutics offered 4.7 million shares in its initial public offering last week for a midpoint price of $40 ...Learn More
Medtech startup gets $5.9M boost
A funding round involving 52 investors brought in $5.9 million for InterVene, according to a regulatory filing with the ...Learn More
Pa. medtech firm takes in $3M in debt financing
Pennsylvania-based medtech firm Intact Vascular said in a filing with the Securities and Exchange Commission that it has ...Learn More
Calhoun Vision names former Bausch & Lomb exec as new CEO
Rick Heinick, former executive vice president and chief human resources and transformation officer at Bausch & Lomb, was ...Learn More
Sensor-embedded inhaler to track asthma of Ky. patients
The personalized asthma management system from Propeller Health will be used as part of a collaboration between public, ...Learn More
Positive results reported in 2 studies of Sebacia's acne management system
A novel approach using lasers, gold-coated particles and ultrasound to treat acne, developed by the clinical-stage medtech ...Learn More
MRI-safe pacemakers from Biotronik land FDA nod
The FDA granted Biotronik approval to market its dual- and single-chamber ProMRI Eluna pacemakers to be used with its Setrox ...Learn More
FDA clears catheter system from Vascular Pathways
The AccuCath 3.1" BC Midline Catheter, developed by Vascular Pathways for patients with challenged peripheral vasculature, ...Learn More
EU approves STD molecular Dx tests from Becton Dickinson
European regulators have granted Becton Dickinson CE mark approval for its BD Max CT/GC and CT/GC/TV tests. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
I will either find a way or make one.
Hannibal, military ...Learn More
GOP senators include medical device tax repeal in budget proposal
A budget proposal that includes language to repeal the 2.3% excise tax on medical devices was introduced Wednesday by ...Learn More
Funding round brings in $16M for N.J. medtech firm
Svelte Medical Systems has obtained $16 million in a financing round led by New Science Ventures, CNF Investments and the ...Learn More
NanoString's breast cancer Dx test available in Canada
NanoString has struck a deal in which LifeLabs Medical Laboratory Services will offer its Prosigna Breast Cancer Prognostic ...Learn More
Stimwave to expand workforce, move headquarters to Fort Lauderdale, Fla.
Stimwave Technologies is planning to hire 20 more workers as it launches the Freedom Stimulator, an implantable device that ...Learn More
Q4 revenue soars for Veracyte
Veracyte generated $12.2 million in revenue in the quarter ending Dec. ...Learn More
Blue Belt's robotic surgery device debuts in Australia
A patient at Mater Hospital in Sydney was the first in Australia to undergo a procedure using Blue Belt Technologies' Navio ...Learn More
FDA clears advanced PAD testing technology from Semler
A next-generation system developed by Semler Scientific for peripheral artery disease testing has received 510(k) clearance ...Learn More
FDA OKs study of Simplify Medical's artificial cervical disc
Simplify Medical received an investigational device exemption from the FDA to conduct a study comparing its Simplify Disc, ...Learn More
EU approves bone screw system from Silver Bullet
European regulators have granted Silver Bullet Therapeutics CE mark approval for its OrthoFuzIon Cannulated Bone Screw ...Learn More
FDA labels Medtronic's sheath recall as Class I
A recall involving Medtronic's FlexCath Select Steerable Sheath has been categorized by the FDA as Class I. ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
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Ever tried. Ever failed. No matter. Try again. Fail again. Fail better.
Samuel Beckett, ...Learn More
Zimmer-Biomet deal likely to be approved by EU regulators, sources say
The acquisition of Biomet by Zimmer for $13.4 billion is set to receive conditional approval from antitrust regulators in ...Learn More
Growth-stage Dx company gets $4M boost
DiabetOmics has obtained $4 million in a funding round led by Ventureast. ...Learn More
Lucigen pulls in $2.2M from private financing round
A private financing round has brought in $2.2 million for Wisconsin-based Lucigen. ...Learn More
DNA testing company gets funding boost to develop new Dx tests
Spartan Bioscience, an on-demand DNA testing firm, has obtained an investment from Canon USA to finance the development of ...Learn More
MPTronic enters distribution partnership with SST Group
SST Group has struck a deal to exclusively distribute MPTronic's RDM device in Canada and the U.S. ...Learn More
Who are medtech's favorites in Congress?
Check out an analysis of the political donations the medical device industry gave legislators last year. Read the ...Learn More
Report predicts strong growth for wearables market through 2020
An IndustryARC report predicts an annual growth rate of 21.3% through 2020 for the global wearable medical devices market. ...Learn More
New deadline set for comments on drug-device combo GMP rules
The FDA has moved the deadline from March 30 to April 29 for comments on the draft good manufacturing practices guidance for ...Learn More
Requirements for Class IV medtech products updated in South Korea
The Ministry of Food and Drug Safety in South Korea will require clinical data for a large number of Class IV medical ...Learn More
Peripheral stent from Medtronic gets expanded approval from FDA
The FDA has granted Medtronic expanded approval for use of its Protege GPS stent in treating peripheral artery disease ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
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AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
People won't have time for you if you are always angry or complaining.
Stephen Hawking, theoretical ...Learn More
U.S., EU regulators approve "leadless" ICD from Boston Scientific
The Emblem S-ICD, a "leadless" implantable cardiac defibrillator developed by Boston Scientific, has obtained FDA approval ...Learn More
Maker of diabetes management tool gains $16.5M in Series B financing
Glooko has obtained $16.5 million in a Series B funding round that includes Medtonic as an investor. ...Learn More
Deal to acquire Ivera Medical finalized by 3M
3M has concluded its proposed acquisition of Ivera Medical, a San Diego firm that makes the Curos port connector caps for ...Learn More
Ariz. molecular Dx firm gets $3.9M boost
A private equity offering involving 24 investors has brought in $3.9 million for Scottsdale, Ariz.-based Provista, according ...Learn More
Q4 revenue increases for Calif. molecular Dx firm
CareDx reported a 36% year-over-year revenue increase in the quarter ending Dec. 31. ...Learn More
Positive results reported in 2 studies of Glide Technologies' injection system
The Glide SDI, a solid dose injection system developed by Glide Technologies, demonstrated promising results in two clinical ...Learn More
Test uses single drop of blood to produce point-of-care results
A device that can offer point-of-care results by analyzing one drop of blood has been developed by Cleveland-based Apollo ...Learn More
SpineFrontier records first use of spinal-fusion device in North America
A patient at USMD Hospital at Arlington in Texas has undergone anterior cervical disc fusion using SpineFrontier's Arena-C ...Learn More
Program focuses on using Big Data to advance medical device, drug approval process
The "FDA: Advancing Medical Innovation" initiative was unveiled by the Bipartisan Policy Center to ask Congress to allow the ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Trichomonas Assay, developed by Quidel, has obtained clearance from the FDA. ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
The vitality of a new movement in art must be gauged by the fury it arouses.
Logan Pearsall Smith, ...Learn More
Becton Dickinson-CareFusion deal closes today
Becton Dickinson and CareFusion said their proposed $12 billion merger will close today after it was approved last week by ...Learn More
NuCryo Vascular enters distribution partnership with Vascular Solutions
The PolarCath, a balloon catheter designed to alter and dilate atherosclerotic plaque, was launched by Vascular Solutions in ...Learn More
Novation to continue deal with Bacterin for bone matrix, allograft technologies
A deal between Bacterin and Novation has been extended, allowing members of Novation to access proprietary Bacterin ...Learn More
MicroRNA-based test drives revenue growth for Rosetta in 2014
Rosetta Genomics generated $1.3 million in revenue in 2014, compared with $709,000 in 2013. ...Learn More
Medtronic reports positive trial results for heart valve
A 747-patient, multisite study in the U.S. ...Learn More
ISO certification granted to Accelerate Diagnostics' quality-management system
Accelerate Diagnostics has been granted ISO certification for its quality-management system. ...Learn More
Zimmer records first use of shoulder-replacement device in U.S.
An American patient has undergone reverse shoulder replacement using Zimmer's Vivacit-E Liner, marking the first time the ...Learn More
Cobas DPX assay from Roche gets CE mark
European regulators have granted Roche CE mark approval for its cobas DPX assay, which detects parvovirus B19 and hepatitis ...Learn More
FDA clears use of Toshiba's 4DCT with Aquilion scanner
Toshiba America Medical Systems has obtained FDA clearance to sell its Infinix 4DCT in combination with the company's ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
You cannot shake hands with a clenched fist.
Indira Gandhi, prime minister of ...Learn More
Heart device from Boston Scientific lands FDA nod
The FDA has approved Boston Scientific's Watchman Left Atrial Appendage Closure Device, which is intended to minimize the ...Learn More
Ohio imaging firm sets IPO's midpoint price at $52M
ViewRay said it intends to offer 4 million shares in its initial public offering at $12 to $14 per share, making the ...Learn More
N.C. metabolomics firm gets $5M boost
An additional $5 million was raised by Metabolon in a Series E funding round extension, bringing its total for that round to ...Learn More
Q2 revenue increases for N.Y. Dx firm
Enzo Biochem generated $23.1 million in revenue in the quarter ending Jan. ...Learn More
Ultrasound good alternative to MRI for gluteus tendinitis
Ultrasound was nearly equal to MRI for identifying gluteus tendinitis in patients with greater trochanter pain syndrome, ...Learn More
Eko Devices raises $2M, prepares clinical trials for EHR-connected stethoscope attachment
Eko Devices has raised $2 million in funding and is preparing to begin clinical trials of its EHR-connected stethoscope. ...Learn More
Tracking program for medtech-tied adverse events approved in India
A nationwide materiovigilance program was approved by the health ministry of India to make sure that medical devices are ...Learn More
Stent-delivery device from Lombard wins approval in Japan
Japanese regulators have given Lombard Medical Technologies approval to market its AorFlex system in that country. ...Learn More
EU approves Volcano's lesion-assessment tool
Regulators in Europe have given Volcano CE mark approval for its iFR Scout software, a tool that analyzes serial lesions and ...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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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A person will sometimes devote all his life to the development of one part of his body -- the wishbone.
Robert Frost, ...Learn More
Rules for disinfecting reusable medical devices finalized by FDA
The FDA has finalized its guidelines governing the disinfecting and cleaning of endoscopes and other reusable medical ...Learn More
Maker of bariatric surgical devices obtains $50M loan
Athyrium Capital Management has granted Apollo Endosurgery a loan package worth $50 million. ...Learn More
Wis. imaging systems startup obtains $4.5M boost
HealthMyne, which has developed a clinical imaging analytics technology, has raised $4.5 million in a Series A funding ...Learn More
Analysis: Small bone orthopedics market grew over 7% in 2014
An analysis by ReportBuyer found a more than 7% increase in the U.S. ...Learn More
Q4 revenue increases for Trovagene
Trovagene generated $56,000 in revenue in the quarter ending Dec. ...Learn More
U.S. trial begins for Medtronic's drug-eluting stent
A U.S. ...Learn More
Assurex taps technology provider in pharmacogenomics test deal
Luminex has struck a deal to use its xTag, a universal tag technology, in improving the capacity and processing speed of ...Learn More
EU OKs precision medical instruments from JustRight Surgical
European regulators have granted JustRight Surgical CE mark approval to market all of its FDA-cleared precision medical ...Learn More
Somna Therapeutics gets FDA nod for acid reflux device
Somna Therapeutics received FDA approval for the REZA BAND, a medical device that applies pressure to the neck to reduce ...Learn More
EU restores approval of aortic valve implants from St. Jude
European regulators reinstated the CE mark to the 25-mm and 23-mm versions of St. ...Learn More
Short Course on Adaptive Design
April 28Westin Crystal City, Arlington, Va. ...Learn More
8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop
April 29-30Westin Crystal City, Arlington, Va.This annual workshop, co-sponsored by the FDA and AdvaMed, brings together ...Learn More
Love is the only force capable of transforming an enemy into a friend.
Martin Luther King Jr., civil rights ...Learn More
Zimmer floats $7.65B debt for merger deal
Zimmer is offering senior notes worth $7.65 billion to help finance its merger with Biomet's parent company, LVB ...Learn More
N.J. insulin pump maker sets IPO's midpoint price at $75M
Valeritas said it intends to offer 5 million shares in its initial public offering at $14 to $16 per share, making the ...Learn More
Wash. mitral valve device maker gets $15M boost
An additional $15.2 million was raised by Cardiac Dimensions in a funding round extension, bringing its total for that round ...Learn More
Q4 revenue soars for Invitae
Invitae generated $875,000 in revenue in the quarter ending Dec. ...Learn More
Australian state looks to support medtech with $1.7M investment
A plan to invest almost $1.7 million in a medtech knowledge hub has been announced by the government of New South Wales, ...Learn More
Smiths Medical to move headquarters to Plymouth, Minn.
Smiths Medical is transferring its headquarters from Arden Hills, Minn., to Plymouth, Minn. ...Learn More
Stimwave records first U.S. patients implanted with pain-relief device
Patients at the National Institute of Pain in Lutz, Fla., were the first in the U.S. ...Learn More
Sponge-detection technology from RF Surgical debuts in U.S.
The RF Assure Detection System X, designed to help surgical teams avoid leaving sponges inside a patient's body, was ...Learn More
Web-based tool helps determine MRI compatibility of devices
An online tool called ProMRI System Check was unveiled by Biotronik. ...Learn More
EU approves cochlear implant, 3 electrodes from Advanced Bionics
HiRes 90K Advantage, a cochlear implant developed by Advanced Bionics for patients with single-sided deafness, has obtained ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
You gain strength, courage and confidence by every experience in which you really stop to look fear in the face.
Eleanor Roosevelt, first ...Learn More
Calif. robotic surgery device maker gets $35M boost
A private placement involving a syndicate of investors has pulled in $35 million for Hansen Medical. ...Learn More
Commercial assets of Covis acquired by Concordia in $1.2B deal
Concordia Healthcare, a medtech firm in Ontario, has agreed to pay $1.2 billion to buy the commercial assets of Covis ...Learn More
U.S. investors pump $14.3M into Australian molecular Dx firm
A financing round has brought in about $14.3 million for Australian molecular diagnostics company Genetic Technologies after ...Learn More
Bacterin enters distribution partnership with Spartan Medical
Spartan Medical has struck a deal to distribute Bacterin's proprietary products to medical facilities affiliated with the ...Learn More
Higher sales in China help fuel Q4 revenue growth for Mindray
Mindray Medical International generated $399 million in the quarter ending Dec. ...Learn More
Varian Medical to expand facility in Ga.
Palo Alto, Calif.-based Varian Medical Systems has announced plans to open a hub in Fulton County, Ga., by expanding its ...Learn More
Fio, Corgenix team up on rapid Ebola test
A partnership deal was reached between Corgenix Medical and Fio to develop a technology that will provide patients in remote ...Learn More
Illumina partners with Merck Serono on cancer test development, marketing
Illumina and Merck Serono have agreed to collaborate on the creation of a universal oncology test that would help in the ...Learn More
Registrants grapple with new medtech nomenclature system in Russia
The more rigorous requirements for filing products together in a single registration as well as the missing and incomplete ...Learn More
Tornier's shoulder repair device cleared by FDA
The Simpliciti shoulder-repair device from Amsterdam-based orthopedics firm Tornier has received 510(k) clearance from the ...Learn More
Molecular Diagnostics and the Changing Landscape
March 12-13Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices
Nov. ...Learn More
All my life, I always wanted to be somebody. Now I see that I should have been more specific.
Jane Wagner, writer and ...Learn More
Spinal device maker gets $3M boost
A private placement divided into two tranches pulled in about $3 million for Aurora Spine. ...Learn More
SEC filing: Sigma-Aldrich paid $170M for Cell Marque
Sigma-Aldrich paid around $170 million in October to buy Cell Marque, a maker of in vitro diagnostic antibody kits and ...Learn More
Vt. medtech firm purchased by Graphic Controls
Graphic Controls, a maker of medical, gaming and industrial products, agreed to pay an undisclosed sum to acquire ...Learn More
Exact Sciences enters co-promotion deal with Ironwood
Ironwood Pharmaceuticals struck a nonexclusive deal to co-promote Exact Sciences' Cologuard, a colorectal screening test, ...Learn More
Higher test volume drives Q4 revenue growth for Biocept
Biocept generated $76,000 in revenue in the quarter ending Dec. 31, compared with $19,000 in the same period a year earlier. ...Learn More
U.S. patent covering syringe cartridge issued to Minimus Spine
Minimus Spine has secured a U.S. ...Learn More
FDA clears Dx display tool from Barco
The Nio 5MP LED, a diagnostic display system from Barco, has obtained clearance from the FDA. ...Learn More
Zoll gains FDA OK for automated CPR system
The ResQCPR system, an automated cardiopulmonary resuscitation device from Zoll Medical, has received premarket approval ...Learn More
FDA authorizes use of Kaneka's kidney-failure device
The FDA has authorized the use of Kaneka's Lixelle Beta 2-microglobulin Apheresis Column, a device used together with ...Learn More
Mobile Health, Wellness and Medical: A Privacy Workshop
April 22Washington, D.C. ...Learn More
Technical Writing for Regulatory Submissions
May 12Washington D.C.Don't let the writing style of your submission lead to a rejection of your 510(k) or PMA application. ...Learn More
The higher we are placed, the more humbly we should walk.
Cicero, ...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
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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
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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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
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 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
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
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Art is either plagiarism or revolution.
Paul Gauguin, French ...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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