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. Here’s how GE wants to make anesthesia machines smarter
GE officials think their Mini Field Agent – a plug-and-play connectivity device used in many industries – could enable smarter use of anesthesia machines and other medical devices.
The Boston-based conglomerate is in the process of rolling out the Field Agent to health providers. About 10 health provider customers are already using the Mini Field Agent for anesthesia machines; the goal is for about 100 customers to use it by next year. Read more
4. Neovasc shares rise on Tiara transcath mitral valve trial update
Neovasc today updated on the clincial study of its Tiara self-expanding transcatheter mitral valve bioprosthesis designed to treat mitral regurgitation, touting 31 successful implants and a 12.1% rate of 30-day mortality.
The Vancouver-based company said that to date 34 patients have been treated with the Tiara at 10 centers globally, with a technical implantation success rate of 91.1%. Read more
3. Appeals court shoots down Synthes bid to unseal grand jury records in Norian bone cement trial
Johnson & Johnson subsidiary DePuy Synthes lost its bid to have some rand jury records unsealed for a wrongful death lawsuit brought over its Norian bone cements.
At least 5 patients died during otherwise routine operations after the Norian cement was used off-label in their spine surgeries. The bone cement was initially developed by a company called Norian, which Synthes bought in 1999 for about $50 million. Synthes, in turn, was acquired by J&J for $21.3 billion in 2012. Read more
2. Medtronic launches StealthStation ENT surgical navigation system
Medtronic said today it launhced its StealthStation ENT surgical navigation system designed for otolaryngology procedures.
The StealthStation ENT works by generating an electromagnetic field around the target patients’ anatomy during surgery so instrument positioning can be dynamically tracked, the Fridley, Minn.-based company said. Read more
1. FDA to pilot new high-risk PMA for medical devices
The FDA is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month.
The federal safety watchdog is seeking nine companies to participate in its Premarket Approval Application Critical to Quality program beginning Sept. 29 and running to either Dec. 31, 2018, or until nine PMAs have enrolled. The goal is to streamline the PMA process “while assuring that a firm’s quality system includes rigorous controls for features and characteristics considered critical to the safety and effectiveness of the device,” the FDA said. Read more
