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. St. Jude calls global stop to Nanostim implants over battery issues
St. Jude Medical said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting.
The Little Canada, Minn.-based company, said it pulled implants of the micro-sized leadless, catheter delivered Nanostim pacer after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there have been no reports of patient injuries associated with the malfunction. Read more
4. Litmus Health looks to bring wearables to drug development
Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials.
The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting health-related quality of life as the primary motivation for clinical development. Massive sets of data collected from wearables will help to inform researchers about their patients quality of life outside the clinic. Read more
3. Senseonics submits FDA PMA application for Eversense CGM
Senseonics said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system.
The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said. Read more
2. Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system
Corindus Vascular Robotics said yesterday that it won 510(k) clearance from the FDA for the CorPath GRX, it’s 2nd-generation vascular robot-assisted surgery platform, and plans to have it on the market during the 1st quarter of 2017.
Waltham, Mass.-based Corindus said it added several features to the latest CorPath iteration, including the ability to control the guide catheter in 1mm increments to precisely position balloon or stent catheters during percutaneous coronary interventions. Read more
1. St. Jude Medical shareholders grudgingly approve executive tax breaks ahead of Abbott merger
Shareholders in St. Jude Medical, who this week voted to approve its pending, $25 billion merger with Abbott, grudgingly approved a measure to give tax breaks to its senior executives if the deal goes through.
Little Canada, Minn.-based St. Jude’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax laws on stock owned by executives and directors for the 6 months before and after a merger transaction. Read more
The post MassDevice.com +5 | The top 5 medtech stories for October 28, 2016 appeared first on MassDevice.
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