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European Commission: Entry into force of MDR, IVDR set for late May 2017
By Stewart Eisenhart, Emergo Group During the Eudamed Steering Committee meeting of December 14, 2016 the current state of play regarding the introduction of the new Medical Device Regulations (MDR)...
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iCad deals VersaVue software, DynaCAD to Philips InVivo unit for $3.2m
iCad (NSDQ:ICAD) said yesterday that it agreed to deal its VersaVue software and DynaCAD breast and prostate imaging devices to Royal Philips‘ (NYSE:PHG) InVivo unit for $3.2 million. Nashua,...
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AtriCure warns on tip detachment risk with Cobra Fusion cardiac ablation device
AtriCure (NSDQ:ATRC) in September warned doctors of the risk that the tip of its Cobra Fusion cardiac ablation catheter could dislodge and separate from the device. The Cobra Fusion device is designed...
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FDA approves Alcon’s AcrySof IQ ReStor intraocular lens
Novartis‘ (NYSE:NVS) eye care business, Alcon, said today that it won FDA approval for its AcrySof IQ ReStor multifocal toric intraocular lens. The lens treats presbyopia and pre-existing corneal...
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EnteroMedics readies 1-for-70 reverse split
EnteroMedics (NSDQ:ETRM) said today that its board declared a 1-for-70 reverse stock split effective Dec. 28, as part of the company’s plan to regain compliance with the NASDAQ exchange’s $1.00 minimum...
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Mesoblast gains on A$29m investment deal with Mallinckrodt
Shares in stem cell company Mesoblast Ltd (ASX:MSB) rose 7% to A$1.51 yesterday after it said that it entered into an equity purchase agreement with US drugmaker Mallinckrodt Pharmaceuticals...
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Presbia announces 2-year Microlens data from PMA trial
Presbia (NSDQ:LENS) touted interim data today from its U.S. pivotal clinical trial, which it hopes will eventually support pre-market approval from the FDA for its Flexivue Microlens. The company is 2...
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FDA expands clearance for Avinger’s Lightbox L250 vascular imaging console
Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after...
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NanoVibronix lands Health Canada nod for patch-based wound healing device
NanoVibronix (NSDQ:NVBXU) said today that it won approval from Health Canada to sell its WoundShield device in Canada. The Elmsford, N.Y.-based company has also won CE mark approval for the device in...
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IntelGenx, Endo Ventures ink development and commercialization deal
IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new...
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OneMedNet, Vida Diagnostics partner to develop image sharing for pulmonologists
OneMedNet Corp. said today that it landed a collaboration deal with Vida Diagnostics Inc., to develop an image exchange and data sharing solution for diagnostic and therapeutic procedural workflows for...
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Researchers develop nanodiscs to deliver personalized cancer therapy
Researchers from the University of Michigan have developed nanodiscs that deliver a customized therapeutic vaccine to treat colon and melanoma cancer in mice. The team’s work was published in Nature...
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MassDevice.com +5 | The top 5 medtech stories for December 28, 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 warns batteries in medical carts associated with fires, explosions
The FDA issued a warning today to healthcare professionals regarding the safety hazards associated with battery-powered mobile medical carts. The federal watchdog said it has received numerous reports...
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NeuroMetrix raises $7m in private placement of preferred stocks, warrants
NeuroMetrix (NSDQ:NURO) said today that it entered into a definitive securities purchase agreement with an undisclosed investor for a private offering of 7,000 shares of Series E convertible preferred...
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Medtronic’s Ev3 wins 2nd appeal in ex-rep’s whistleblower lawsuit
A federal appeals court last week dismissed a whistleblower lawsuit filed by a former sales rep for Medtronic (NYSE:MDT) subsidiary Ev3, ruling that the allegations weren’t strong enough to sustain a...
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Minerva Surgical raises $16.7m for Aurora endometrial ablation device
Minerva Surgical reported a funding round worth $16.7 million and said it wants to raise $10 million more. Redwood City, Calif.-based Minerva, founded in 2008, is developing technologies for treatment...
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Appeals court resuscitates Infuse lawsuit against Medtronic
A federal appeals court yesterday resuscitated a shareholders lawsuit accusing Medtronic (NYSE:MDT) of concealing for nearly 10 years the negative side effects of its Infuse bone growth protein. The...
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Gates Foundation puts $140m into $206m round for Intarcia
Intarcia Therapeutics said today that it raised a $206m Series EE round and inked a deal with the Bill & Melinda Gates Foundation to fight HIV in emerging nations. It’s the 2nd of 3 tranches in an...
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Alere sues CMS to reinstate its Arriva diabetes unit
Alere (NYSE:ALR) yesterday said that it’s suing to force the Centers for Medicare & Medicaid Services to reinstate its Arriva diabetes division’s enrollment, after the government health insurer...
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