Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. Aethlon plans IDE, slims losses on Q1 report
Aethlon Medical said it plans to file for Investigative Device Exemption status for its HemoPurifier after the company’s contract with DARPA expires, and reports slimmed losses for the company and investors.
In a quarterly earnings call, CEO Jim Joyce said this would be the company’s last year on contract with DARPA, with a caveat of a possible extension to 2016, and the company hoped to pursue IDE clearance from the FDA once the contract is ended. Read more
2. Boston Scientific cuts 455, closes 2 facilities; Abbott drops 244
Boston Scientific and Abbott are making cuts from their workforce, according to a California Warn notice report.
Boston Scientific is slated to cut 455 employees as it closes 2 facilities in the Fremont and San Jose areas. The company said it is moving the operations to a manufacturing facility in Costa Rica. Read more
1. FDA: IDE review times reduced by nearly a year
The FDA released a report detailing improvements in clearing medical devices, stating it reduced investigational device exemption times by roughly a year.
In the report, published as part of the agency’s renewal of the Medical Device User Fee act, the federal watchdog covered the agency’s improvements over the past 5 years at hastening its time-to-decision for IDEs, pre-market approvals and 510(k) clearances. Read more
The post MassDevice.com +3 | The top 3 medtech stories for August 14, 2015 appeared first on MassDevice.
from MassDevice http://ift.tt/1fcdRyq
Cap comentari:
Publica un comentari a l'entrada