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. Gecko Biomedical lands $1.6m loan for surgical adhesives
Gecko Biomedical said today that it landed a $1.6 million, interest-free loan from Bpifrance for the surgical adhesives it’s developing.
Paris-based Gecko, which pulled down a $25 million Series A2 round in March, said the €1.4 million loan will go toward clinical trials in Europe aimed at winning CE Mark approval during the 1st half of 2017. Read more
4. Study: Initially CE Marked medical devices have higher recall rate
U.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of safety alerts and recalls, according to a new study published in The BMJ.
Researchers, led by Harvard’s Thomas Hwang, examined press releases and announcements of approvals, as well as public FDA and European regulatory authority databases for U.S. approvals, safety alerts and recalls to gauge different rates of recalls and alerts dependent upon where the devices 1st won approval. Read more
3. JustRight Surgical wins FDA 510(k) for 3mm pediatric vessel sealing system
JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system.
The Boulder, Colo.-based company touted the win as the 1st and only from the FDA for an electrosurgical device designed specifically for pediatric patients. Read more
2. Appeals court upholds patent win for Medtronic’s Cardiocom
A federal appeals court yesterday upheld a win for Medtronic subsidiary Cardiocom in a patent battle with Robert Bosch Healthcare Systems.
The U.S. Court of Appeals for the Federal Circuit upheld rulings by the U.S. Patent & Trademark Office’s Patent Trial & Appeal Board that invalidated a trio of Bosch patents. Read more
1. Medical device companies fear parallel regulation after Brexit vote
Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and E.U markets, according to a new report from ScienceBusiness.
Only 2 weeks ago, the Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted to endorse new medical device and in vitro diagnostic regulations. Read more
The post MassDevice.com +5 | The top 5 medtech stories for June 30, 2016 appeared first on MassDevice.
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