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. Profound Medical looks to raise $15m
Profound Medical said today that it pulled in a $13.2 million (C$17.4 million) funding round that includes an over-allotment option that could bring in another $2 million (C$2.6 million).
Led by GMP Securities, the syndicate of underwriters agreed to buy 15.82 million shares at about ¢84 (C$1.10) apiece, with an optional over-allotment of 2.373 million shares for the 30 days following the offering’s expected close Nov. 14. Read more
4. Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial
Intersect ENT said today that its Resolve sinus implant met both primary endpoints in its Resolve II pivotal trial.
The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure. Read more
3. Medrobotics lands expanded indication for Flex robot-assisted surgery device
Medrobotics said today that its Flex robot-assisted surgery device won CE Mark approval in the European Union, expanding its indication to include colorectal procedures. The Raynham, Mass.-based company claims to be the 1st robotics firm to offer minimally invasive and steerable robotic products for colorectal applications.
“CE Mark for colorectal procedures is significant since it expands the number of patients who can be treated with the Flex robotic system and provides a true platform technology that multiple hospital departments can use,” CEO Samuel Straface said in prepared remarks. “When combined with the unrivaled mobility of the system, European otolaryngology and colorectal surgeons can now perform minimally invasive surgery through the body’s natural orifices, offering the potential for truly scarless surgeries.” Read more
2. Report finds delays, loopholes in FDA’s adverse event reporting
The FDA allows medical device companies to file adverse event reports well after the fact and to conceal most of the details from public view, according to agency records obtained by the Minneapolis Star Tribune under the Freedom of Information Act.
The newspaper’s analysis showed that the FDA allowed medical device companies to file “retrospective summary reports” covering more than 300,000 adverse events, at an average of about 3 years after the 30-day filing deadline. Since 2005 the FDA has let some 2 dozen firms file late reports, the newspaper found, after waiting 13 months for the agency’s response to its FOIA request and then challenging a decision to cloak some of the totals as corporate trade secrets. Read more
1. Coating issue still plagues the Pipeline device as Medtronic issues another recall
The coating issue that’s bedeviled the Pipeline device made by Medtronic last week prompted another recall for the brain aneurysm treatment.
Originally developed by Ev3, the Pipeline device is designed to divert blood from the aneurysm. Covidien acquired Ev3 in the summer of 2010, paying $2.6 billion in cash, and the technology moved to Medtronic with its $50 billion buyout of Covidien last year. The FDA approved Pipeline in March 2011. Read more
The post MassDevice.com +5 | The top 5 medtech stories for October 17, 2016 appeared first on MassDevice.
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