FDA identifies participants for pre-cert digital health tech pilot

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has named all nine participants, including both major technology companies and start-up healthcare software developers, in a new pilot program for digital health product precertification. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

Saudi regulators reportedly exempt some Class I medical devices from registration

By Stewart Eisenhart, Emergo Group Regulators at the Saudi Food and Drug Authority (SFDA) may soon exempt some Class I medical devices from registration requirements according to Emergo sources in Riyadh. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not

Avacen receives Health Canada nod for fibromyalgia pain relief device

Avacen’s medical device designed to treat joint pain from arthritis recently received licensing from Health Canada to use the device for treating fibromyalgia. The Avacen 100 Class II medical device was previously licensed to treat joint pain that comes with arthritis for a drug-free muscle relaxer. Before the device’s new licensing, the only way to

Rfxcel expands capabilities to Europe

Rfxcel announced its plans to expand its capabilities to help life science companies meet serialization and regulatory compliance needs in Europe. The company specializes in traceability and serialization because of its leaders who understand data accuracy, global compliance and serialization. Mark Davison will lead the European team as the senior director of operations for Europe.

4 top medtech stories you need to know in late 2017

The U.S. government continues to create a lot of uncertainty for the medical device industry, but medtech companies are still making some big moves. The frenzy of major mergers continues, which makes sense from an investor standpoint when it comes to reducing risk. Meanwhile, companies from outside the industry – including such high-tech giants as Apple,

Pages: 1 2 3 4 5

Medtech stories we missed this week: Sept. 29, 2017

From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance

Industry trade groups want full MDR, IVDR implementation in U.K. post-Brexit

By Stewart Eisenhart, Emergo Group Medical device and IVD trade groups in Europe and the UK have appealed to maintain a uniform system for CE Marking and regulatory oversight as negotiators work out British withdrawal from the European Union under Brexit. Get the full story here at the Emergo Group’s blog. The opinions expressed in

Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

Invuity is back with its PhotonBlade

Invuity has reintroduced its PhotonBlade to the market, more than three months after it recalled the minimally invasive surgery light due to “unintended energy discharge” during procedures. The new and improved PhotonBlade includes what Invuity officials describe as enhancements to improve energy delivery and provide optimized illumination performance.  The new PhotonBlade will ship to customers

Cognition to touting compliance and commercialization at DeviceTalks Boston

Cognition Corp., headquartered in Lexington, Mass., has been offering solutions for medical device, pharmaceutical, and combination products compliance and commercialization for more than 10 years. The Cockpit Platform provides the framework for an extensive set of compliance templates. These templates, which include Risk Management and Design Controls, along with professional services, give companies a jump-start

Medtech stories we missed this week: Sept. 22, 2017

From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals,

South Korean regulators change new medical device regulations

By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

Russian regulators changing medical device, IVD regulations

By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in

China has a new medical device classification catalog: what you need to know

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.