MassDevice.com +5 | The top 5 medtech stories for September 6, 2017

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. Get this in your inbox everyday by subscribing to our newsletters.   5. Did Congress just kill medical device innovation? The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications. Drues, who has worked with both device companies and FDA, has clients speeding up de novo applications to get them turned in before the fees take effect on Oct. 1. Read more 4. Pulmatrix licenses inhaled COPD drug to Vectura Pulmatrix said today that it licensed its inhaled COPD drug to Vectura. The PUR0200 compound combines tiotropium bromide and Pulmatrix’s iSperse drug-delivery technology. Vectura plans to use its dry powder inhaler device to deliver PUR0200, the company said. Read more 3. Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs Boston Scientific has prevailed in dismissing a whistleb...
Source: Mass Device - Category: Medical Devices Authors: Tags: News Well Plus 5 Source Type: news