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Alcon wins FDA nod for CyPass Micro-Stent
Novartis (NYSE:NVS)’s Alcon unit won FDA clearance for its CyPass Micro-stent designed to reduce intraocular pressure in patients suffering from glaucoma, according to an FDA release posted today. The...
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UDI guidance: Five key steps to FDA unique device identifier compliance
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers...
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Verily, GlaxoSmithKline partner to form $713m joint Galvani Bioelectronics
GlaxoSmithKline (NYSE:GSK) said today it is partnering with Google‘s (NSDQ:GOOG) Verily to form Galvani Bioelectronics, a new firm focused on bioelectronic medicine. Bioelectronic medicine operates...
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Intuitive partners with Dextera on robotic surgery stapler
Intuitive Surgical (NSDQ:ISRG) said it inked a joint development deal with Dextera Surgical (NSDQ:DXTR) to develop a surgical stapler and cartridge for Intuitive’s da Vinci robotic surgical system. The...
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Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic...
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Philips releases set of connected mobile health tools
Royal Philips (NYSE:PHG) today announced the launch of a series of connected personal health devices , including a health monitoring watch, scale, blood pressure monitor and thermometer, all designed...
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Medtronic wins expanded CE Mark for Evolut R TAVR system
Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at...
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Haemonetics sees shares rise on Q1 release
Haemonetics (NYSE:HAE) has seen shares rise despite releasing 1st quarter earnings that saw losses grow and earnings per share shrink compared to last year. The Braintree, Mass.-based company reported...
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Essential Medical wins FDA IDE nod for vascular sealer
Essential Medical said today it won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study will run across 10-16 sites...
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Invuity prices $28m offering
Invuity (NSDQ:IVTY) last week priced a new $28 million public offering of common shares, looking to float $2.8 million shares at $10 a piece. The new offering comes with a 30-day underwriters option to...
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MassDevice.com +5 | The top 5 medtech stories for August 1, 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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Cantel Medical picks up Accutron for $52m
Cantel Medical (NYSE:CMN) said today it acquired Accutron for approximately $52.5 million. Accutron manufactures nitrous oxide delivery systems and single-use nasal masks, and will be folded into the...
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Medpace prices $161m IPO
Contract research organization Medpace today released the pricing for its initial public offering, looking to float 7 million shares at between $20 and $23 per share, which will bring in between $140...
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ReVision Optics touts Raindrop inlay study data
ReVision Optics today released results from a trial of its Raindrop near vision inlay, touting significantly improved near and immediate vision and no loss of distance binocular acuity in subjects with...
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Piloting an improved intercenter consult process
By: Michael Rappel, Ph.D., and Rachel E. Sherman, M.D., M.P.H. Over the last few months, we’ve shared what FDA is doing to improve the review of combination products, including establishing the...
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Gore wins FDA nod for Tigris vascular stent
W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating peripheral artery disease. The 3rd-generation dual-component stent...
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Boston Scientific issues urgent field safety notice for select Lotus valves
Boston Scientific (NYSE:BSX) this week issued a voluntary field safety corrective action for its Lotus Valve Systems, looking to recall units from the field over issues with release mandrel breakage....
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TransEnterix sells 1st ALF-X unit
TransEnterix (NYSE:TRXC) said today it sold the 1st ALF-X surgical robotic system to Milan, Italy’s Humanitas Hospital. The company acquired the Telelap ALF-X robot-assisted surgery device from Italy’s...
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SteadyMed raises $32m
SteadyMed Therapeutics (NASDAQ:STDY) today announced a new $32 million round of funding through a 2-tranche private placement. The round was led by new investor OrbiMed and joined by existing investors...
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Glaukos raises guidance after Street-beating Q2
Glaukos (NYSE:GKOS) today released 2nd quarter earnings that topped The Street’s expectations for earnings per share and revenue marks, lifting its full year 2016 revenue expectations. The Laguna...
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