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Sanovas CEO Larry Gerrans and the MicroCam technology
Sanovas CEO Gerrans goes linear with new MicroCam

Sanovas' new MicroCam plug-and-play endoscopic imaging system paves the way for a paradigm shift toward linear medical devices for natural orifice surgery, CEO Larry Gerrans tells MassDevice.com.

Data and Healthcare
Podcast: Healthcare giants unite to turn Big Data into medtech savings

A quartet of healthcare giants including UnitedHealth, the largest single health insurer in the U.S., joins forces for the SharedClarity project, aiming to leverage their combined Big Data to get the best devices for the best prices.
The E-bay of medical devices: A conversation with Aptitude's Troy Kirchenbauer
Building the E-bay of medical devices: A conversation with Aptitude's Troy Kirchenbauer

MassDevice talks disruptive business models in the medical device and hospital world with Novation executive and aptitude vice president Troy Kirchenbauer
Emergency Preparedness Checklist
FDA advisors look to Hurricane Katrina, Japanese tsunami for lessons in protecting medtech systems

Although current quality systems are likely sufficient, the FDA should look to lessons learned from recent catastrophes in developing risk mitigation strategies to better protect medical devices and related systems, an agency panel says.
Biomet CEO (and blogger) Jeff Binder takes a strong stand on gain-sharing
Biomet CEO (and blogger) Jeff Binder takes a strong stand on gain-sharing

Biomet CEO Jeff Binder tells MassDevice.com why gain sharing is bad for the medical device business and how the best is yet to come for the orthopedics sector.

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Medical device sales: Wright Medical's pilot program on rep-less sales process worth watching
Medical device tax: How much are companies paying to government for healthcare reform?
Vascular Solutions CEO: Boston Scientific's alleged patent infringement 'blatant'
Boston Scientific may finally be on the right path again
Globus Medical sues J&J's DePuy Synthes unit over spine implant patent

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Simulation  of  Implantable  Nitinol  Stents  
The superelastic, shape memory, biocompatibility and fatigue properties of Nitinol, have made the material attractive for cardiovascular stents

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D+Vice Talk - May 23, 2013
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MassDevice.com +3 | The top 3 med-tech stories for May 23, 2013

May 23, 2013 by Arezu Sarvestani

If you read nothing else today, make sure you're still in the know with MassDevice +3.

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

News Well, Plus 3

D+Vice Talk - May 23, 2013

May 23, 2013 by Arezu Sarvestani

See video

Welcome to the latest edition of the MassDevice.com's D+Vice Talk, our new webcast, in which we review medical device stories from the last week.

In this episode we talk about Wright Medical's salesperson-free sales model, the FDA's new appeals process proposal, winners and losers in the new Medicare reimbursement rates and Angelina Jolie's decision to undergo a preemptive double-mastectomy.

Find all of today's referenced stories here:

Medical device tax:

EuroPCR: Volcano touts positive early results for its lesion assessment system

May 23, 2013 by Sony Salzman

Volcano posts positive preliminary findings demonstrating the benefit of a hybrid iFR/FFR approach to simplify lesion assessment and avoid drugs.

Volcano

Volcano Corporation (NSDQ:VOLC) posted positive early findings for its instant wave-Free Ratio (iFR) coronary lesion detector, with results form its Advise II trial supporting results from older retrospective publications, according to a report unveiled during a hot line late-breaking clinical trial session at the EuroPCR meeting in Paris, France.

News Well, Clinical Trials, Conference coverage, EuroPCR

European regulators green-light valve-in-valve procedures

May 23, 2013 by Arezu Sarvestani

Medical device giant Medtronic says its European CE Mark is the 1st ever regulatory approval for valve-in-valve treatment for patients with degenerated surgical aortic valves.

Medtronic logo

European regulators for the 1st time approved a medical device for transcatheter valve-in-valve treatment in patients with degenerated surgical aortic valves, granting CE Mark approval to medtech titan Medtronic (NYSE:MDT) for its CoreValve and CoreValve Evolut devices.

News Well, Regulatory/Clearance, CE Mark, Replacement Heart Valves

Biosense Webster launches Afib ablation study for nMARQ system

May 23, 2013 by Sony Salzman

Johnson & Johnson subsidiary Biosense Webster enrolls its 1st patient in the reMARQable clinical study evaluating the nMARQ pulmonary vein isolation system in treatment of paroxysmal atrial fibrillation.

Biosense Webster logo
News Well, Clinical Trials, Ablation, Investigational Device Exemption (IDE), Catheters, Research & Development

FDA panel to consider down-classifying blade-form dental implants

May 23, 2013 by Arezu Sarvestani

The FDA's Dental Products Panel is scheduled to deliberate on whether the agency should lower blade-form dental implants to a lower risk class.

FDA logo

An FDA advisory panel will consider in July whether to down-classify blade-form endosseous dental implants from the highest risk category to a less stringent class.

The FDA is now proposing to reclassify this pre-amendments class III device into class II because the federal watchdog believes that special controls, together with general controls, can effectively mitigate risks to health posed by these devices, according to the agency's federal register notice.  

News Well, Dental , Food & Drug Administration (FDA), Regulatory/Compliance

EuroPCR: New data showing reduced mortality in InspireMD's MGuard stent trial

May 23, 2013 by Sony Salzman

InspireMD presents new 6 month follow-up data showing better survival rates for its MGuard stent

InspireMD

InspireMD (OTC:NSPR) presented new 6-month follow up data for its MASTER trial showing lower mortality rates in patients treated with its MGuard stent. The company's findings were presented today at the STEMI symposium of the annual EuroPCR meeting in Paris, France.

The trial measured all-cause mortality for patients treated with the company's MGuard stents compared to a control group treated with bare metal stents or drug-eluting stents.

News Well, EuroPCR, Stents
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