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Medicare: Medical device companies paid out $200m to physicians last year

Medical device companies' aggregate spend on payment and other gifts to physicians was at least $200 million last year, according to the U.S. Health & Human Services Dept., but critics (and the agency itself) flag widespread problems with the Open Payments database.

Checking on Orange County's medtech climate with OCTANe's Matthew Jenusaitis

Orange County, Calif.'s most-connected man, OCTANe's Matthew Jenusaitis talks to MassDevice.com about OCTANe's 2014 Medical Device Investor Forum.

What's behind the slump in early-stage medtech investment?

Blame the medical device tax and the U.S. regulatory environment for the slump in investment in early-stage medical technologies, Silicon Valley Bank's Ben Johnson tells MassDevice.com.

Kimberly-Clark readies Halyard Health medical device spinout

Halyard Health, the publicly traded, $1.6 billion spinout of Kimberly-Clark's medical device business, is slated to go live in November, soon-to-be COO Chris Lowery tells MassDevice.com.

HART CEO David Green on the transformative potential for regenerative medicine

David Green tells MassDevice.com about the decision to split Harvard Bioscience and Harvard Apparatus Regenerative Technology, his choice to move over to the new entity and why regenerative technologies are poised to transform medicine.

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BREAKING: Jury clears DePuy in 1st Pinnacle bellwether trial

October 23, 2014 by Brad Perriello

A federal jury in Texas reportedly clears Johnson & Johnson's DePuy Pinnacle hip implant in the 1st bellwether product liability trial over the metal-on-metal device.

BREAKING: Jury clears DePuy in 1st Pinnacle bellwether trial

UPDATED Oct. 23, 2014, with comment from DePuy.

Edwards Lifesciences posts double-digit Q3 sales, earnings increases

October 23, 2014 by Brad Perriello

Edwards Lifesciences reports 3rd-quarter sales and earnings growth in excess of 20% and raises its outlook for the rest of the year.

Edwards Lifesciences posts double-digit Q3 sales, earnings increases

MassDevice.com +3 | The top 3 medtech stories for October 23, 2014

October 23, 2014 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.

 

Auditors: FDA needs to boost cybersecurity

October 23, 2014 by Val Kennedy

Federal auditors say the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.

Auditors: FDA needs to boost cybersecurity

Federal auditors have determined the FDA needs to ramp up its cybersecurity efforts in order to deter hackers.

Auditors for the U.S. Health & Human Services Dept.'s Inspector General's Office tested many of the FDA's IT systems in the wake of a security breach last October that exposed approximately 14,000 user accounts.

ReFlow has new Wingman35 in U.S. market

October 23, 2014 by Alexander Soule

ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter.

ReFlow has new Wingman in U.S. market

On the heels of CE Mark approval in Europe, ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter and said it has already been used in California vascular clinics.

Stealth hypertension startup Sympara Medical raises nearly $6m

October 23, 2014 by Alexander Soule

Sympara Medical quietly secures $5.5 million in funding from a handful of investors as it develops a device to treat hypertension.

Stealth hypertension startup Sympara Medical raises nearly $6m

Stealthy Sympara Medical quietly secured $5.5 million in funding from a handful of investors for the hypertension device it's developing.

San Francisco-based Sympara disclosed the funding in a regulatory filing, after recording $4.3 million with the SEC in 2013.

Gynesonics wins FDA nod for VizAblate pilot trial

October 23, 2014 by Alexander Soule

Gynesonics wins investigational device exemption from the FDA for a pilot trial of its VizAblate uterine fibroid treatment.

Gynesonics wins FDA nod for VizAblate pilot trial

Gynesonics said it won an FDA investigational device exemption for its VizAblate system with an outpatient option for treating symptomatic uterine fibroids.

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