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The stem cell ‘skin gun’ that’s aiming to disrupt wound care
RenovaCare’s SkinGun uses a patient’s own stem cells to heal their wounds faster and more efficiently than a traditional skin graft. Pennsylvania state police officer Matthew Uram suffered severe...
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Tandem Diabetes Care prices $22.5m public offering
Tandem Diabetes Care (NSDQ:TNDM) today announced the pricing details of a $22.5 million underwritten public offering. The company priced 18 million shares of its common stock at $1.25 apiece. Tandem...
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Supreme Court declines review of Retractable Tech case against BD
Retractable Technologies (NYSE:RVP) said on Monday that the US Supreme Court denied its request to review an overturned $352 million anti-trust win over Becton Dickinson (NYSE:BDX). With the ruling,...
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InVivo wins Health Canada nod for cervical neuro-spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today it won Health Canada approval to initiate a clinical study of its neuro-spinal scaffold in patients with acute, complete AIS A cervical spinal cord injuries....
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Valeritas prices $53m IPO
Valeritas today priced its upcoming initial public offering, looking to raise $52.5 million through the sale of 5.25 million shares at $10 per share. The offering includes a 30-day underwriters option...
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Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries...
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Ethicon closes Torax Medical buy
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it closed its acquisition of Torax Medical, and its Linx acid reflux treatment portfolio, for an undisclosed amount. The Linx system from...
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BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the...
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Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow...
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Zoll Medical wins Health Canada nod for next-gen AEDs
Zoll Medical said this week it won approval from Health Canada for its Zoll AED 3 and Zoll AED 3 BLS automated external defibrillators and launched them in the region. Both newly-cleared AEDs provide...
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How to hire a compliance-minded CRO
Clinical research sponsors continue to outsource the management of their clinical trials, spending millions of dollars for a pivotal phase and significant risk medical device trial. Choosing a...
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MassDevice.com +5 | The top 5 medtech stories for March 23, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Biosensors International launches US pivotal for BioFreedom DCS
Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent. The Singapore-based company’s Leaders Free II study is an ongoing trial...
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NuVasive shareholders win class action cert in alleged kickback case
A federal court this week certified a class of NuVasive Inc. (NSDQ:NUVA) investors in a suit alleging that the company lost share value after it hid a kickback scheme. A judge in the US District Court...
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House delays vote on Trumpcare bill
The US House of Representatives today indefinitely delayed its vote on the Trumpcare legislation, which looks to begin dismantling Obamacare and replacing it with a GOP-supported framework. The Trump...
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Little or no audit preparation common device QMS problem
By Stewart Eisenhart, Emergo Group In the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how...
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Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7...
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European advisory committee backs label update for Nordisk’s Tresiba
Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its...
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Heart Societies update guidelines to support cardiac monitors for syncope...
Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for...
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Lilly details plans for $850m investment in U.S. operations
Eli Lilly (NYSE:LLY) said today that it plans to invest $850 million in its U.S. operations in 2017. The company presented details of its plans at the Lilly Technology Center in Indianapolis, joined by...
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