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Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease....
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MassDevice.com +5 | The top 5 medtech stories for October 24, 2016
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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FDA delays Inovio phase III trial of DNA immunotherapy candidate
Inovio Pharmaceuticals (NSDQ:INO) said today that the FDA placed a hold on its proposed Phase III clinical program for its investigational DNA immunotherapy candidate designed to treat pre-cancers and...
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Harvard touts 1st 3D-printed organ-on-a-chip with integrated sensing
Researchers from Harvard University developed what they tout as the 1st entirely 3D-printed organ-on-a-chip with integrated sensing. The heart-on-a-chip was quickly manufactured by a fully automated,...
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aTyr Pharma wins FDA Fast Track Designation for muscular dystrophy therapy
aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic...
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In-utero heart surgery patient is now 3 and healthy
At just 24 weeks of gestation, Tucker Roussin underwent fetal surgery at the Children’s Hospital of Philadelphia to treat a life-threatening tumor connected to his heart. Now, he is a healthy...
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FDA, CMS extend parallel review program indefinitely
The FDA and Centers for Medicare & Medicaid Services said today that the Parallel Review of Medical Devices pilot program will be fully implemented and extended indefinitely. The program from the...
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BioCardia closes Tiger X Medical merger
BioCardia said today it closed its merger with Tiger X Medical (OTC:CDOM), with the combined company retaining the BioCardia name and “BCDA” ticker. San Carlos, Calif.-based BioCardia said it converted...
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Baxter launches Theranova dialyzer in Europe, Down Under
Baxter (NYSE:BAX) said today it launching its novel Theranova HDx hemodialysis therapy system in Australia, New Zealand, France, Germany, Switzerland and Belgium. The device operates around the...
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FDA puts Acclarent’s Aera Eustachian tube balloon in Class II
The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device. The Irvine, Calif.-based company’s Aera system consists of...
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Zimmer Biomet wins 2nd NexGen Flex bellwether
Zimmer Biomet (NYSE:ZBH) last week won the 2nd bellwether lawsuit brought over its NexGen Flex knee replacement, after a federal judge in Illinois found that the plaintiff failed to prove that a design...
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Indian regulators open comment period for proposed medical device rules
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: Draft medical device regulations have been published in India’s Official Gazette. Industry has 30 days (until mid-November 2016) to...
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FDA launches public whistleblower site for ‘regulatory misconduct’
The FDA last week launched a whistleblower website designed to let whistleblowers let the federal safety watchdog know about allegations of “regulatory misconduct” on the part of medical device makers....
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Baxter jumps on classic Q2 beat-n-raise
Baxter (NYSE:BAX) posted a classic beat-and-raise 2nd quarter today, handily topping expectations on Wall Street, boosting its outlook for the rest of the year and sending its share price up in early...
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UCB’s Cimzia AutoClicks pen hits the U.K. market
UCB (EBR:UCB) said today that its Cimzia AutoClicks pre-filled pen is available in the U.K., after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the device...
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There’s no quit in Abbott whistleblower Colquitt
The whistleblower behind a decade-old lawsuit against Abbott (NYSE:ABT) won’t say die, asking a federal appeals court last week to order a new trial after a jury shot him down earlier this year. Former...
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Imprimis touts ‘dropless therapy’ study for cataract surgery
Imprimis Pharmaceuticals (NSDQ:IMMY) touted data today from a peer-reviewed study of patients who received its “dropless therapy” following cataract surgery. The San Diego-based company uses a...
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Dipexium crashes after Locilex Phase III trials fail
Shares in Dipexium Pharmaceutical (NSDQ:DPRX) dived 84% today after it reported that its OneStep-1 and OneStep-2 Phase III clinical trials of Locilex in patients with mild infections of diabetic foot...
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Novartis focus on still-ailing Alcon shifts to 2017
(Reuters) –Novartis‘ (NYSE:NVS) struggling Alcon eye care division will take longer to turn around than expected, the Swiss drugmaker’s Chief Executive Joe Jimenez warned on Tuesday as he reported a...
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Flowonix warns on MRI risk for Promectra implantable pump
Flowonix Medical issued an urgent field safety notice late last month warning of risks associated with magnetic resonance imaging procedures for patients with its Prometra implantable pump, which...
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