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 news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath
Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital.
The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow System also comes after the successful completion of a number of bench and animal studies. Read more
4. Boston Scientific issues urgent field safety notice for select Lotus valves
Boston Scientific 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.
The company is looking to “remove units from the field” that were manufactured prior to a component related change made in March this year, and specified that units manufactured after the change was implemented are not affected. Read more
3. Glaukos raises guidance after Street-beating Q2
Glaukos 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 Hills, Calif.-based company reported profits of $2.3 million, or 6¢ per share, on sales of $28.6 million for the 3 months ended June 30. Read more
2. TransEnterix sells 1st ALF-X unit
TransEnterix 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 Sofar SpA last September. The Telelap ALF-X device has CE Mark approval in the European Union for minimally invasive surgery procedures. Read more
1. 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 features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, the Newark, Del.-based company said. Read more
The post MassDevice.com +5 | The top 5 medtech stories for August 2, 2016 appeared first on MassDevice.
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