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. 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 whistleblower suit alleging its sales of the Cognis cardiac resynchronization therapy defibrillators and Teligen implantable cardioverter defibrillators between 2008 and 2009 violated various false claims acts, according to court documents released late last week.
In the suit, Boston Scientific was accused of defrauding the FDA by not reporting alleged defects in the devices which caused insecure connections between the leads and headers they attached to. Read more
2. Cook Medical urology biz launches Mauna Kea’s Cellvizio in US
Cook Medical said today its urology business has launched Mauna Kea‘s Cellvizio confocal laser endomicroscopy system, with a deal to distribute the device in the US.
The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level. The system allows the operating physician to visualize the internal microstructure of tissue in real time during ureteroscopic and cytoscopic procedures, the companies said. Read more
1. FDA warns Entellus Medical over Xpress sinus dilator pediatric trial
The FDA sent a warning letter to Entellus Medical over its failure to prevent physicians from violating the approved protocol for a pediatric trial of its Xpress sinus dilator.
The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a Plymouth, Minn., Entellus plant that the FDA conducted to review the company’s procedures in sponsoring the pediatric Xpress study. Read more
The post MassDevice.com +5 | The top 5 medtech stories for September 6, 2017 appeared first on MassDevice.
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