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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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MassDevice.com +7 | The top 7 med-tech stories for the week of May 13, 2013

May 18, 2013 by Brad Perriello

Plus Seven

Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com's coverage highlights our seven biggest and most influential stories from the week's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

News Well, Plus 7

FDA lowers regulatory bar for ingestible sensors

May 17, 2013 by Ingrid Mezo

The FDA lowers the regulatory bar for ingestible event markers, downgrading them from Class II to Class III devices.

FDA lowers regulatory bar for ingestible sensors

Effective today, the FDA is down-classifying ingestible event markers from the more burdensome Class III into Class II (special controls).

An ingestible event marker is a prescription device used to record time-stamped, patient-logged events, the agency noted. The ingestible component links wirelessly through intra-body communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.

News Well, Regulatory/Compliance

Tryton Medical launches side-branch stent in Europe

May 17, 2013 by Ingrid Mezo

Tryton Medical launches its side-branch short stent in Europe after winning CE Mark approval.

Tryton Medical launches side-branch stent in Europe

UPDATED May 17, 2013 with comment from Tryton CEO Shawn McCarthy.

Tryton Medical said it got the green light in Europe for its side-branch short coronary stent to treat bifurcation lesions in large vessels.

The new stent is 15mm, 3mm shorter in the main branch zone than the standard Tryton side-branch stent, the Durham, N.C.-based medical device company said.

News Well, CE Mark, Regulatory/Compliance, Stents

A cure for coffee breath?

May 17, 2013 by Brian Johnson

Colgate-Palmolive files for U.S. patent protection for a toothbrush with a caffeine patch.

A cure for coffee breath?

Here's a good way to eliminate coffee breath and still get your morning off on the right foot.

News Well, Dental

Thoratec announces FDA approval of HeartMate II pocket controller

May 17, 2013 by Ingrid Mezo

The FDA approves Thoratec's pocket controller for its HeartMate II implantable heart pump.

Thoratec logo

Thoratec (NSDQ:THOR) said it got the go-ahead from the FDA to market its HeartMate II pocket controller.

The pocket controller is designed to support the active lifestyles of patients with HeartMate II left ventricular assist devices, the Pleasanton, Calif.-based medical device company stated in a press release.

News Well, Cardiac Assist Devices, Pre-Market Approval (PMA), Regulatory/Compliance

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

May 17, 2013 by Ingrid Mezo

Direct Flow Medical wins FDA approval for a U.S. trial of its new transcatheter aortic valve implant.

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.

News Well, Clinical Trials, Investigational Device Exemption (IDE), Regulatory/Compliance, Replacement Heart Valves

Prosthetics makers sue Medicare over payment rules

May 17, 2013 by Brian Johnson

The American Orthotic and Prosthetic Assn. sues Medicare and the U.S. Health & Human Services Dept. over reimbursement policies for prosthetic devices.

gavel

The trade association representing prosthetic medical device makers filed a lawsuit in federal court against Medicare and the U.S. Health & Human Services Dept. over what it calls "unfair and unauthorized" payment rules.

In a complaint filed in the U.S. District Court for the District of Columbia, the American Orthotic and Prosthetic Assn. alleged that the government is unfairly denying payment to suppliers of prosthetic devices.

Legal News, News Well, Medicare, Prosthetics

A Goldilocks approach to leaky blood vessels: Not too stiff, but not too loose

May 17, 2013 by MassDevice

A Goldilocks approach to leaky blood vessels: Not too stiff, but not too loose

Blood vessels won't grow properly in tissues that are too stiff or too loose. (Project Gutenberg/Wikimedia Commons)

By Tom Ulrich

News Well, Vector Blog, Vascular
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