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Status Report: Health Canada, CMDCAS, US FDA and the MDSAP
By Ken Pilgrim, Emergo Group On December 4, 2015, Health Canada (HC) confirmed their transition plan for the Medical Device Single Audit Program (MDSAP). The intentions of the MDSAP are that a single...
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Supreme Court declines to review Medtronic win in InFuse lawsuit
The U.S. Supreme Court yesterday declined to review a Medtronic (NYSE:MDT) win in a lawsuit alleging off-label promotion of its controversial InFuse bone-growth protein. Patricia Caplinger asked the...
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Insulet inks deal for Lilly’s Humalog concentrated insulin
Insulet (NSDQ:PODD) said yesterday that it inked a deal with Eli Lilly (NYSE:LLY) to develop a version of its flagship OmniPod device that uses a concentrated insulin made by the pharma giant. Lilly’s...
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Advanced Inhalation Therapies scales back IPO terms to $10m
Advanced Inhalation Therapies yesterday scaled its pending initial public offering by more than ⅔ as it looks to raise funds for its drug delivery device, which is designed to treat severe respiratory...
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HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on...
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J&J joins Edwards in $28m Series B for arterial shunt dev V-Wave
Johnson & Johnson (NYSE:JNJ) joined previous investor Edwards Lifesciences (NYSE:EW) in a $28 million Series B round to support heart failure treating interarterial shunt maker V-Wave, according...
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Smith & Nephew buys Piramal’s BST-CarGel cartilage repair assets
Smith & Nephew (NYSE:SNN) said to day that it acquired the BST-CarGel cartilage repair line from Piramal Healthcare for an undisclosed amount. BST-CarGel, which is approved in Australia, Canada and...
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Boston Scientific launches LithoVue 1-use Ureteroscope
Boston Scientific (NYSE:BSX) said today it launched its LithoVue single-use digital flexible ureteroscope designed for minimally invasive endoscopic procedures such as diagnosing and treating stones...
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No quick fix seen for Novartis’s troubled Alcon unit
(Reuters) – Introduced a decade ago, glaucoma drug Travatan Z has been a powerful driver behind the success of Novartis (NYSE:NVS)’s Alcon eye care business, its second biggest division behind the main...
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Philips inks $90m patient care deal with Marin General Hospital
Royal Philips (NYSE:PHG) said today it signed a 15-year, $90 million patient healthcare partnership with Marin General Hospital, which serves Marin County, just north of San Francisco. The agreement is...
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U.S. panel finalizes breast cancer screening recommendations
(Reuters) – An influential panel of U.S. experts issued final recommendations on Monday reaffirming their controversial position that mammogram screening should start at age 50, but also said some...
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Senate panel OKs Califf for FDA commish
The U.S. Senate’s health panel today approved President Barack Obama’s nominee to lead the FDA, cardiologist Dr. Robert Califf, after members shrugged off criticism from consumer watchdogs about...
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Dentsply, Sirona shareholders clear $5.56B merger
Dentsply International (NSDQ:XRAY) and Sirona Dental Systems (NSDQ:SIRO) said yesterday their shareholders “overwhelmingly” approved their proposed $5.56 billion merger. The companies said that...
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MassDevice.com +3 | The top 3 medtech stories for January 12, 2016
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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Moody’s: MDT’s $5B buyback ‘credit positive,’ but rating unchanged
Medtronic (NYSE:MDT)’s move to use some of its freed up $9.3 billion to repay debt is “credit positive,” but won’t change the medical giant’s rating or outlook, according to a Moody’s report published...
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NASDAQ to delist Perseon, CEO Carnell to take no pay
Perseon Medical Corp. (NSDQ:PRSN) said it received a notice from Nasdaq informing the company its stock will be delisted after a failure to comply with annual meeting rules, and announced its CEO...
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Sofinova spinout HealthQuest raises $175m fund
Sofinnova Ventures-spun out HealthQuest Capital is looking to raise $175 million for a new fund focused on the healthcare industry, according to an SEC filing posted this week. The firm looks to invest...
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Stryker pleural drainage device recall is Class I
The FDA this week labeled Stryker‘s (NYSE:SYK) Fuhrman & Pneumopericardial drainage set recall as Class I. The recall was issued over problems with the device breaking off in the pleural cavity...
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VC shops back managed healthcare in Docent Health play
(Reuters) – Three large U.S. venture capital firms are betting that hospitals will buy into a new service designed to help healthcare providers treat their patients more like upscale hotels treat their...
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Team NB survey shows fewer CE Mark certifications, more withdrawals since 2010
By Stewart Eisenhart, Emergo Group A recent survey of European Notified Bodies (NBs) shows that these organizations issued fewer CE Mark certifications for medical devices between 2011 and 2014 than in...
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