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Gov. Deval Patrick's life sciences legacy

MassDevice.com looks at the life sciences legacy of former Massachusetts Gov. Deval Patrick.

Weight loss: 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 patients.

DeviceTalks podcast: Masimo CEO Kiani

An interview with medtech entrepreneur Joe Kiani, CEO of Masimo Corp. and the founder of the Patient Safety Movement Foundation, recorded at DeviceTalks West Nov. 19, 2014.

HeartFlow wins FDA OK for non-invasive FFR system

The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.

DeviceTalks podcast: B. Braun Medical CEO Caroll Neubauer on device tax, Obamaca

Caroll Neubauer, the CEO of B. Braun Medical, sits down for a wide-ranging interview on the hottest topics facing the medical device industry.

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As many as 20 million young American women may be silently suffering from a debilitating disorder that few have ever heard of and even fewer admit to. That
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FDA names cardiologist Califf to senior leadership position

January 26, 2015 by MassDevice

The FDA names cardiologist and researcher Dr. Robert Califf of Duke University to be deputy commissioner for medical products & tobacco.

FDA names cardiologist to senior leadership position

(Reuters) — The FDA today named Dr. Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA.

Supremes send patent cases back to appeals court

January 26, 2015 by MassDevice

The U.S. Supreme Court remands a trio of patent cases back to a lower court for further proceedings in light of a ruling the justices issued last week.

Supremes send patent cases back to appeals court

MassDevice.com +3 | The top 3 medtech stories for January 26, 2015

January 26, 2015 by MassDevice

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech 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.

 

Medtech approvals: FDA releases November 2014 PMAs

January 26, 2015 by MassDevice

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2014.

FDA logo

Summary of PMA Originals & Supplements Approved

  • Originals: 2
  • Supplements: 67

Summary of PMA Originals Under Review

  • Total Under Review: 55
  • Total Active: 26
  • Total On Hold: 29

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Summary of PMA Supplements Under Review

U.S. wants to move Medicare away from fee-for-service

January 26, 2015 by MassDevice

The Obama administration wants to change the way Medicare reimburses doctors, moving from a fee-for-service model to alternative payment models emphasizing cost containment and quality of care.

U.S. wants to move Medicare away from fee-for-service

(Reuters) — The Obama administration today unveiled an ambitious plan to control health costs by moving the $2.9 trillion U.S. healthcare systems away from costly fee-for-service medicine, beginning with the Medicare program for the elderly and disabled.

Rox Medical's Coupler hypertension stent fares well in pivotal trial

January 26, 2015 by Mark Hollmer

Rox Medical's stent-like Coupler implant, designed to treat resistant hypertension, fares well in a pivotal trial.

Rox Medical's Coupler hypertension stent fares well in pivotal trial

A stent-like device designed to treat high blood pressure fared well in a pivotal trial comparing it with treatment with drugs alone.

U.K. warns on Smith & Nephew's Renasys wound care device

January 26, 2015 by Brad Perriello

Regulators in the U.K. issue a medical device alert on Smith & Nephew's Renasys negative-pressure wound therapy device, following a field safety notice the company issued last October.

U.K. warns on Smith & Nephew's Renasys wound care device

Accused killer of Boston Scientific executive pleads guilty

January 26, 2015 by Brad Perriello

Lyle 'Ty' Hoffman reportedly pleads guilty to intentional 2nd-degree murder in the shooting death of former Boston Scientific executive Kelly Phillips.

Accused killer of Boston Scientific executive pleads guilty

Hoffman (l) and Phillips