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Seventh Sense launches pivotal trial for Tap100 blood draw device
Seventh Sense Biosystems said today it launched a pivotal trial for its Tap100 touch activated blood collection device. Medford, Mass.-based Seventh Sense said it expects to file for marketing...
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IsoRay spikes GliaSite radiation therapy device
IsoRay (NYSE:ISR) said yesterday that it’s spiking its GliaSite radiation therapy system for treating brain cancers, after achieving only modest sales since the FDA cleared the device in 2011....
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FDA clears AtriCure’s CryoForm cryoablation probe
AtriCure (NSDQ:ATRC) said yesterday it won FDA 510(k) clearance for its CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation. The CryoForm is...
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Battelle’s NeuroLife uses thought to control paralyzed limbs
Patient Ian Burkhart (front) and project electrical engineering lead Nick Annetta (back right). (photo by Battelle) Researchers at Battelle today published a paper in Nature covering the progress of...
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Torax touts 1st US use of Fenix incontinence system
Torax Medical said today that the 1st U.S. implantation of its Fenix magnetic continence restoration system was performed late last week. The Fenix system is made up of a series of magnetic titanium...
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MassDevice.com +5 | The top 5 medtech stories for April 13, 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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Avoiding regulatory escalation
There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a...
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US regulators aim to ban founder of blood-testing firm Theranos
(Reuters) – U.S. federal health regulators have proposed banning Theranos Inc founder Elizabeth Holmes from the blood-testing business for at least 2 years after determining that the company failed to...
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Report: Feds impanel grand jury in Boston Scientific pelvic mesh probe
A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out...
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Fresenius rebrands dialysis division to Fresenius Kidney Care
Fresenius Medical Care (NYSE:FMS) said yesterday it rebranded its dialysis service division under the new name Fresenius Kidney Care. With the move, Waltham, Mass.-based said it launched a new website...
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CryoLife buys Genesee BioMed’s PhotoFix pericardium patch
CryoLife Inc. (NYSE:CRY) said today it exercised its right to acquire Genesee BioMedical’s PhotoFix bovine pericardium patch for $2.3 million in cash. Atlanta, Ga.-based Cryolife said it had the option...
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RefleXion closes $46m Series B
California-based medtech group RefleXion Medical said today it closed a $46 million Series B round of financing, with funds slated to expand its engineering, regulatory and commercial organizations....
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IBM Watson’s DiSanzo updates on partnerships, regulatory compliance
International Business Machine (NYSE:IBM)’s Watson Health biz CEO Deborah DiSanzo spoke yesterday on how the company aims to improve how healthcare firms handle and use their data and updated on...
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Investors find safety in J&J shares, but run could stall
(Reuters) – After lagging a 6-year healthcare sector run fueled by fast-growing biotech companies, Johnson & Johnson (NYSE:JNJ) shares have beaten the group in 2016 as investors turn to safety in...
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MassDevice.com +5 | The top 5 medtech stories for April 14, 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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BMC claims wins in continued spat with ResMed over CPAP patents
BMC Medical today claimed the approval of a motion for a voluntary dismissal of an appeal from ResMed (NYSE:RMD) in a long running patent spat as a win for the company. The dispute is part of a...
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J&J’s Ethicon closes NeuWave buy
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it closed its purchase of soft-tissue microwave ablation system maker NeuWave Medical for an undisclosed amount. NeuWave Medical’s...
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Crowd-sourced diabetes app Nightscout details talks with FDA, development
Open-source diabetes app developer Nightscout detailed their development process, including crowdsourcing and their talks with the FDA in a new editorial from the Journal of the American Medical...
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An unheralded story of medtech success – How Sapheon went from an idea on the...
Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider and Partnership Lead at...
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Brazil updates label requirements wireless products
By Michael Cassidy, Emergo Group The Agencia Nacional de Telecomunicacoes (ANATEL) in Brazil has updated its labeling regulations for wireless products, including some medical devices. Resolution 662...
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