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. Report: Valeant shopping sale of surgical eye biz
Valeant Pharmaceuticals is looking to sell its Bausch & Lomb division’s surgical product assets to Carl Zeiss Meditec, according to a Bloomberg report.
The surgical eye assets could be worth approximately $2 billion, according to the report, with a possible agreement still weeks away. Read more
4. FDA lifts warning letter on Masimo plant in California
Masimo said today that the FDA lifted a 2014 warning letter issued over procedures at the Irvine, Calif., plant that makes its Pronto 7 pulse oximeters.
The federal safety watchdog sent the letter in August 2014 after inspections in August to October 2013, flagging Masimo for failing to “review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications,” citing customer complaints “regarding inaccurate readings of the Pronto 7 devices.” Read more
3. Apple Watch to gain direct support for Dexcom G5 glucose sensor
Dexcom and Apple will team up to integrate data directly from Dexcom’s glucose sensors into Apple’s wearable Apple Watch, according to a presentation from the tech company this week.
The update will come alongside updated Bluetooth API for the watch, which will allow the sensor to connect directly to the device, avoiding the need to pass through an iPhone application, according to a CNBC report. Read more
2. FDA approves valve-in-valve procedures for Edwards Lifesciences Sapien 3 TAVR
The FDA yesterday expanded the indication for the Sapien 3 replacement heart valve made by Edwards Lifesciences to include valve-in-valve procedures for aortic and mitral valve patients who are too sick for surgery.
The federal safety watchdog said the expansion is the 1st approval for a transcatheter valve replacement for valve-in-valve procedures when the original surgically implanted valves fail. The procedure involves inserting the Sapien 3 device inside the failed or failing valve. Read more
1. Boston Scientific wins CE Mark for Vercise Gevia DBS
Boston Scientific said today that it won CE Mark approval in the European Union for its Vercise Gevia deep-brain stimulation device for treating movement disorder symptoms.
Marlborough, Mass.-based Boston Scientific said the new system features programming software called the Vercise Neural Navigator 2 with Stimview, designed to allow physicians to see images of the stimulation field while the Vercise Gevia is configured. The MR-conditional, rechargeable system also has an estimated battery life of 25 years, the company said. Read more
