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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.

Sequent Medical CEO Wilder bets on braids

Sequent Medical CEO Tom Wilder tells MassDevice.com why his company's MicroBraid technology is a key differentiator in its Web device for treating brain aneurysms and, potentially, other conditions.

Masimo's Kiani on 'good-enough innovation,' Medtronic, Apple and 25 years of pus

In this DeviceTalks preview, we catch up with Masimo CEO Joe Kiani to discuss new challenges facing the company and how medtech can break the cycle of the era of 'good-enough' innovation.

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Meridian Medical Technologies lands $130m Pentagon deal for nerve agent antidotes

December 19, 2014 by Mark Hollmer

The U.S. Defense Dept. agrees to pay Meridian Medical Technologies $130 million to develop auto-injectors that can deliver nerve agent antidotes.

Meridian Medical Technologies lands $130m Pentagon deal for nerve agent antidotes

Maryland's Meridian Medical Technologies is moving ahead with a whopping $129.5 million U.S. government contract to develop auto-injectors that can deliver nerve agent antidotes.

Bio2 Technologies wins FDA nod for bioactive bone scaffolds

December 19, 2014 by Mark Hollmer

The FDA grants 510(k) clearance for Bio2 Technologies' CLM bioactive scaffold wedges.

Bio2 Technologies wins FDA nod for bioactive bone scaffolds

Massachusetts startup Bio2 Technologies plans a limited rollout in 2015 of its high-tech bioactive bone scaffold wedges, following the FDA's recent 510(k) clearance of the product.

Medicare drops national coverage decisions for some lobotomies, tinnitus masking, others

December 19, 2014 by Brian Johnson

The Centers for Medicare & Medicaid Services will officially remove national coverage decisions for 7 procedures under a program initiated in November 2013, including stereotactic cingulotomy, tinnitus masking and more.

Medicare drops national coverage decisions for some lobotomies, tinnitus masking, others

The Centers for Medicare & Medicaid Services are removing national coverage decisions for 7 medical procedures, including certain types of lobotomies and tinnitus masking devices, after a year-long review initiated in November 2013.

Appeals court overturns triple damages in Stryker-Zimmer spat

December 19, 2014 by Brad Perriello

Zimmer is off the hook for the triple damages it owed Stryker after a patent infringement loss last year.

Appeals court overturns triple damages in Stryker-Zimmer spat

Diabetes: Medtronic advances closed-loop insulin pump

December 19, 2014 by Brad Perriello

Medtronic says it's done with a global user evaluation of a new closed-loop insulin pump with predictive low glucose management technology.

Diabetes: Medtronic advances closed-loop insulin pump

Medtronic (NYSE:MDT) said today that it's done with a global user evaluation program for a next-generation insulin pump system as it pursues the Holy Grail of diabetes: The artificial pancreas.

Report: FDA grounds plan to test unmanned inspection drones

December 19, 2014 by Brian Johnson

The FDA reportedly grounds an internal feasibility study of using unmanned drones in facility inspections.

Report: FDA grounds plan to test unmanned inspection drones

An FDA proposal to test unmanned drones in facility inspections was grounded before it could take flight, according to a report in Regulatory Focus.

An internal FDA memo obtained by the publication revealed that the agency was planning to "perform a test of drone technology" sometime this week.

Pulmonx taps ex-Asthmatx CEO French for the corner office | Personnel Moves

December 19, 2014 by Brad Perriello

Pulmonx taps former Asthmatx CEO Glen French to be its new chief executive.

Pulmonx taps ex-Asthmatx CEO French for the corner office | Personnel Moves

Pulmonx said yesterday that it named Glen French, the co-founder and CEO of Asthmatx who led it to an acquisition by BSX, to be its new president and chief executive.

InSightec names Ferré for board, raises $59m for ExAblate fibroid device | Medtech funding for the week of December 15, 2014

December 19, 2014 by MassDevice

Here's a look at some of the top legal news stories for medical device companies this week: InSightec raises $59m, taps ex-Mako CEO Ferré for board; Engineer looks to crowdfund heart valve; Aethlon sells $3.3m in securities to investment fund; Stealthy Cotera raises nearly $8m for knee implants

InSightec raises $59m, taps ex-Mako CEO Ferré for board

December 15, 2014 by Brad Perriello

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