Bovie Medical (NYSE:BVX) said today it submitted a 510(k) premarket notification to the FDA seeking expanded clearance for its J-Plasma and Renuvion technology. The Clearwater, Fla.-based company, which is looking to rebrand under the new moniker Apyx Medical Corporation beginning next year, said it is looking to clear the system for use in dermal resurfacing procedures. […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
CathWorks wins FDA 510(k) for FFRangio
Non-invasive fractional flow reserve tech developer CathWorks said yesterday that it won FDA 510(k) clearance for its FFRangio non-invasive fractional flow reserve analysis technology. The Israel-based company said that approval came based off of results from the FAST-FFR blinded comparative study study which showed that its FFRangio system was accurate when compared to invasive FFR. “The FDA […]
FDA braces for partial government shutdown
The FDA is preparing for a possible government shutdown after President Donald Trump said he will not sign a continuing resolution to keep the government open through February unless it includes funding for a border wall, which his opposition has stated they will not approve. Even in a shutdown, essential public-health related employees at the […]
UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure
Updated to include response from Bayer. The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device. In an official posting, FDA Commissioner Dr. Scott […]
Here are 5 medtech industry trends you need to know
Whether it’s the slew of mergers and acquisitions or tighter regulation, developments of recent years are having some surprising effects on the medtech industry, according to experts. Money is tight, the largest medical device companies are merging and it’s hard to see where regulation is going – medtech insiders have heard about such trends for years. […]
What you need to know about growing cyber threats to medtech
Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc. And while data theft is a serious threat, the risks posed by hacks that involve the expanding universe of networked medical devices can be especially menacing. Nach Davé and John Pappan, Premier Research […]
FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device
Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts. Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019. “This FDA clearance is an […]
Nemaura prices $2.5m offering to support launch of wearable glucose monitor
Nemaura Medical (NSDQ:NMRD) said this week that it priced a public offering of the company’s common stock and warrants, hoping to reel in $2.5 million in proceeds. The offering is slated to close today. Nemaura plans to use the offering’s proceeds to support the launch of its wearable glucose monitor in Europe, as well as the development of […]
Allergan pulls textured breast implants from the European market
Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee […]
Kleresca cleared to enter Australian, Canadian markets
Dermatological device developer Kleresca said today that it has been certified by the Medical Device Single Audit Program (MDSAP), boosting its plan to enter new markets. The audit gave Kleresca regulatory clearance to enter the medical device markets of Australia and Canada. With minor additional audits and approvals, the certification will also apply to Brazil, Japan, and the United States, […]
FDA eyes reclassification for hyaluronic acid ‘devices’
The FDA announced this week that it is reconsidering its classification of hyaluronic acid intra-articular products designed to treat pain in patients with osteoarthritis of the knee. In the past, these HA products have been regulated as devices. But the U.S. regulatory agency said that the latest scientific literature clarifies that HA uses a chemical […]