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Outside firm backs up short-seller’s claims against St. Jude Medical
Short-selling firm Muddy Waters said today that outside cybersecurity experts validated its claim that cardiac rhythm management devices made by St. Jude Medical (NYSE:STJ) are vulnerable to malicious...
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MDT launches MiniMed Connect app for Android
Medtronic (NYSE:MDT) said today that its MiniMed Connect app, which allows patients with diabetes to see a real-time glucose measurement on their smartphone, is available for Android devices. The app,...
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Legal win leaves Vascular Solutions CEO Root weary of the corner office
Root After being acquitted of federal felony charges for off-label marketing and a prosecution that spanned 5 years, Vascular Solutions (NSDQ:VASC) CEO Howard Root said he’s still recovering from the...
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FDA is working with hospitals to modernize data collection about medical devices
By: Jeffrey Shuren, M.D., J.D. America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an astounding variety of...
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FDA seeks to improve hospital reporting of device injuries
(Reuters) – The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread...
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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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