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FDA releases FY2016 planned guidance docs
The FDA’s Center for Devices and Radiological Health this week released a list of guidance documents it intends to publish for the next fiscal year. The federal watchdog released 3 different lists of...
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MassDevice.com +3 | The top 3 medtech stories for December 28, 2015
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...
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Lung transplants for children: Exploring the intricacies
Most adult transplant centers require patients to walk a set distance in under six minutes to remain a good candidate for lung transplant. The thought is that if patients cannot meet this minimal...
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Study: U.S. patients subject to higher radiation during MPI heart test
Americans undergoing myocardial perfusion imaging to diagnose coronary artery disease, a leading killer in the U.S., are receiving higher levels of radiation than their peers around the world,...
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Samsung to spur wearable health tech with ‘bio-processor’ chip
Samsung Electronics (LON:BC94) today launched its Bio-Processor, a health and fitness monitoring chip which processes 5 different biometric signals, hoping the chip will accelerate development of...
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eyeBrain Medical pulls in $6m for NeuroLens chronic headache treatment
Hybrid neurological and ophthalmological company eyeBrain Medical raised $6 million in a new round of equity financing for its chronic severe headache treatment technology. The company is aiming to...
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PositiveID acquires mobile lab developer E-N-G Mobile Systems
PositiveID (OTC:PSID) said today it acquired specialty vehicle and mobile lab developer E-N-G Mobile Systems for approximately $1 million. ENG’s fastest growing division was its mobile labs segment,...
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The 5 biggest medtech stories of 2015
MassDevice.com‘s editorial team put their heads together and came up with a list of the 5 most significant stories to cross the medical device space in 2015: 1. Mergers & acquisitions run rampant...
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FDA 2015: A look back (and ahead) – Part 1: Medical product innovation
By: Stephen M. Ostroff, M.D. As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting...
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AAHKS names AJRR as official registry
The American Joint Replacement Registry said monday it was named the official registry of the American Association of Hip and Knee Surgeons. AJRR is a non-profit organization that collects data on...
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Soterix Medical wins CE Mark for tDCS depressive disorder therapy
Depression-treating neuromod developer Soterix Medical said yesterday it won CE Mark approval in the European Union for its 1×1 tDCS therapy system designed to treat major depressive disorder. The 1×1...
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Inari Medical raises $6m
Inari Medical today released information on a new $6.1 million equity funding round to support its business and thrombectomy system, according to an SEC filing. Inari produces the FlowTriever...
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Ex-Boston Scientific engineer sentenced to 1 year over stolen trade secrets
A former Boston Scientific (NYSE:BSX) engineer was sentenced to 1 year in prison today for stealing trade secrets related to the company’s balloon dilation catheters. A federal court in Minneapolis,...
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NeuroMetrix reels in $13.8m
NeuroMetrix (NSDQ:NURO) said yesterday it inked a securities purchase agreement with a private institutional healthcare investor for 13,800 shares of Series C convertible preferred stock at $1,000 per...
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The 2016 standards advisory
By John D. Halamka, MD ONC recently released the 2016 Standards Advisory. I think this document is more important than Meaningful Use or Certification in accelerating interoperability. Why? Many...
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BionX pulls in $17m in Series E
BionX said yesterday it pulled in $17 million in a Series E funding round, looking to bring in an additional $8 million by the end of the 1st quarter of 2016 to support its Biom powered ankle...
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Ex-Insulet CEO DeSisto is new chief exec at Mannkind | Personnel Moves
MannKind Corporation said last week it picked up ex-Insulet (NSDQ:PODD) CEO Duane DeSisto as its new prez and CEO, effective January 5, 2016. DeSisto will replace interim CEO Alfred Mann, who has held...
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HeartWare shareholder threatens proxy fight over Valtech merger
HeartWare International (NSDQ:HTWR) may face a proxy battle from a shareholder over its proposed acquisition of Israeli replacement heart valve maker Valtech Cardio, according to an SEC filing posted...
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Vascular Dynamics wins CE Mark for MobiusHD hypertension device
Vascular Dynamics said today it won CE Mark approval for its MobiusHD minimally invasive hypertension treatment device. The MobiusHD is a passive implant delivered percutaneously designed to amplify...
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2015 Year in review: FDA drug and device regulations
In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted...
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