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.
5. AliveCor unveils EKG-equipped Kardia Band for Apple Watch
AliveCor said today it is premiering the Kardia Band EKG-equipped band for Apple’s Apple Watch, designed to provide diagnostic-grade electrocardiogram readings through a smartphone-connected app, as well as a significant update to the company’s existing EKG-monitoring app.
The Kardia Band is a thin wrist band designed specifically for the Apple watch that returns single-lead EKG readings and diagnostics that can be viewed through its app and sent to managing physicians, CEO Vic Gundotra told MassDevice.com in an interview. Read more
4. Jilted Fujifilm questions Toshiba on timing of medical biz sale to Canon
Fujifilm Holdings, which lost out last week to Canon in the race to be picked as preferred bidder for conglomerate Toshiba’s medical device business, questioned Toshiba today on the timing of the deal for Toshiba Medical Systems.
In a letter to embattled Toshiba, Fujifilm cited media reports saying profits from the sale would contribute to Toshiba’s finances in the fiscal year ending this month, questioning whether the deal could close in time. Fujifilm said anti-monopoly regulatory approvals normally take at least a month. Read more
3. Japan approves the Sapien 3 heart valve from Edwards Lifesciences
Edwards Lifesciences said that the Japanese Ministry of Health, Labor & Welfare approved its Sapien 3 transcatheter aortic valve replacement.
Irvine, Calif.-based Edwards said it expects to win reimbursement approval in Japan during the 2nd quarter and launch “immediately thereafter” with a full rollout complete by the end of the year. Read more
2. Boston Scientific, Mayo Clinic reveal hush-hush development program
Boston Scientific and Mayo Clinic today revealed a 3-year-old development program that has about a dozen new products in the pipeline, including a centering catheter for replacement heart valves and a heart failure application for the Precision Spectra spinal cord stimulator.
Four of the roughly 12 products in the hush-hush program, reportedly winnowed from a field of 50 initial ideas, are expected to reach the 1st-in-human trial stage this year. A Boston Scientific executive said the repeal of the medical device tax this year allowed it to take its spend on the program into the multi-million-dollar range. Read more
1. FDA panel OKs Abbott’s Absorb stent
An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott.
The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-1 on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus before dissolving entirely over a period of months. The FDA is not bound to follow the recommendations of its advisory panel but often does. Read more
The post MassDevice.com +5 | The top 5 medtech stories for March 16, 2016 appeared first on MassDevice.
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