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SEC sues Imaging Diagnostic Systems and top execs amid failed FDA bids and...
Federal industry watchdogs accuse Imaging Diagnostic Systems and its lead executives of deliberately misleading investors after the company repeatedly missed FDA deadlines for its breast imaging system...
View ArticlePaulsen Leads Special Order on Repealing the Medical Device Tax
Rep. Erik Paulsen (R-Minn.) leads an hour-long discussion with members of the House of Representatives discussing the repeal of the medical device excise tax.
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Identifying medical devices will strengthen safety
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on...
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UPDATE: FDA panel approves Ocular Therapeutix' ReSeal, with reservations
Ocular Therapeutix gets good and bad news from an FDA advisory panel that reviewed its ReSeal ophthalmic incision sealant.An FDA advisory panel voted yesterday that Ocular Therapeutix's ReSure topical...
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MassDevice.com +3 | The top 3 med-tech stories for Sept. 20, 2013
Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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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Living Cell implants world's 1st patient with regenerative cell therapy for...
Living Cell Technologies says its patient has "recovered well so far" after surgery to implant the experimental NTCELL regenerative cell therapy in treatment of Parkinson's disease. Living Cell...
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Teleflex comes under fire after a surgical tool is left in a patient's neck |...
A patient sues medical device maker Teleflex after a piece of a dilator was left in his neck following throat surgery.MASSDEVICE ON CALL — A patient injured during throat surgery accused medical device...
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Australian regulator issues guidance on mobile medical apps
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the...
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Baxter recalls lock caps on contamination concerns, gets FDA's highest-risk...
"Particular matter" found in the packaging of some of Baxter's Dual Luer lock caps may cause thrombotic and embolic events, spurring a company recall and an FDA Class I label, designating the...
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Langer brainchild Bind Therapeutics launches $70.5M IPO
Massachusetts nanomedicine startup Bind Therapeutics launches a $70.5 million initial public offering at $15 per share in support of the company's Accurins 'programmable' therapeutics technology.Serial...
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Alphatec to lay off 76 from Scient'x, Surgiview subsidiaries
Alphatec says it plans to lay off 76 workers from its French Scient'x and Surgiview subsidiaries, aiming to save up to $6 million a year.Alphatec (NSDQ:ATEC) said it plans to cut 76 positions from a...
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mHealth: LabStyle's diabetes management device and mobile app lands E.U....
Israeli device maker LabStyle Innovations gains 4% on Wall Street today after announcing plans for "soft launch" of its Dario smartphone-based diabetes management system.News Well,...
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Report: Prices drop for major medical implants
Hospitals in 2011 paid 34% less per device for drug-eluting stents than they paid in 2007, according to a new AdvaMed report which also found substantial price-cuts for 6 other categories of major...
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FDA expands clearance for Intuitive Surgical's FireFly imaging system
The FDA expands the 510(k) clearance for Intuitive Surgical's FireFly imaging system to use during gallbladder procedures.Intuitive Surgical (NSDQ:ISRG) said the FDA expanded the 510(k) clearance for...
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mHealth: Many developers off the hook as FDA finalizes rules for mobile...
FDA regulators plan to focus review efforts on only a subset of mobile medical apps that the agency says could pose a risk to patients if not working as intended.The FDA is letting a swath of app...
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MassDevice.com +3 | The top 3 med-tech stories for Sept. 23, 2013
Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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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Medtronic touts AdaptivCRT data on atrial fibrillation
Medtronic touts the 50% reduction in atrial fibrillation in 1 study for patients using its AdaptivCRT feature on their defibrillators.Medtronic (NYSE:MDT) touted a clinical trial it said showed a 50%...
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Edwards Lifesciences lands expanded approval for Sapien heart valve
FDA regulators grant Edwards Lifesciences expanded labeling for the Sapien system, the only transcatheter aortic valve implantation system approved for the U.S. market.News Well, Regulatory/Clearance,...
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Hospitals want more cybersecurity from device makers | MassDevice.com On Call
More healthcare providers are looking to medical device makers to provide better cybersecurity, for fear that vulnerable devices may put the entire hospital network at risk.MASSDEVICE ON CALL — Seven...
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DNR orders and end-of-life decisions for children: The elephant in the room
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching...
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