Mobile and digital health ideas — and overall medtech innovation ideas — abound in Europe, with DeviceTalks Boston attendees getting just a sampling this morning from seven CRAASH Barcelona participants. The CRAASH Barcelona program trains research projects on how to market their health technologies during a three- to five-year period. It’s a boot camp run by EIT Health, the main European healthcare consortium, […]
Europe’s new MDR: Is it as scary as you might think?
The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside […]
Report slams European Union’s high-risk medical device approvals rate
A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. Get the full story on our sister site Medical Design & Outsourcing.
Why U.S. first may be the new medical device development strategy
Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice […]
E.U. publishes final version of medical device regulations
Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late […]
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 […]
EN 60601-1 3rd Edition electrical standard now harmonized in Europe
By Stewart Eisenhart, Emergo Group
Judge cuts Biolase board of directors | Medtech legal news for the week of Mar. 31, 2014
EU launches investigation into pelvic mesh
The European Commission asked a scientific advisory panel to look into the safety of surgical procedures to treat urogynecological conditions using mesh products, which have embroiled their makers in tens of thousands of product liability lawsuits in the U.S.
The EU’s executive body asked its Scientific Committee on Emerging and Newly Identified Health Risks for an opinion on the "safety of surgical meshes used in urogynecological surgery," according to the commission’s request.
U.K. stent biomaterials project lands $8M grant
The ReBioStent project, led by U.K.-based Ceram, landed a $8 million (€5.8 million) grant to put towards developing new biomaterials and new arterial stents.
The ReBioStent project is seeking to develop biodegradable and biocompatible medical products, including stents. The 3-year project began this year and currently has 14 academy and industry partners working on it, according to a press release.
Sorin scores CE Mark for sutureless heart valve
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for the XL version of its Perceval sutureless aortic valve.
Milan-based Sorin said the new approval is for treating patients with annulus sizes ranging from 19 mm to 27 mm using the Perceval device.
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