The New York Times published 2 letters-to-the-editor supporting the 21st Century Cures act after releasing 2 op-eds slamming the act over the past week. The letters came from Marc Boutin, chief exec of the National Health Council and Stephen Ubl, the chief exec of medical device trade association Advamed. Both responses outlined what the authors […]
By: Ben Fisher, Ph.D. At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., […]
By Stewart Eisenhart, Emergo Group South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you […]
By Stewart Eisenhart, Emergo Group Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
Boston Scientific (NYSE:BSX) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Safari2 pre-shaped guidewire designed for placing interventional devices in the heart. The Safari2 is specifically intended for use with transcatheter aortic valve implantation or replacement procedures.. Boston Scientific’s new pre-shaped guidewire is compatible with all TAVI/R […]
By Stewart Eisenhart, Emergo Group Although the European Union has a uniform process, CE Marking, in place to allow registration and marketing of medical devices across all member states, distribution of devices requires regional expertise. In this Emergo podcast, we explain how to identify and vet European device distributors. Edgar Kasteel, Senior Manager at Emergo’s […]
Biotronik said today it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator and launched the device in the U.S. market. The device includes a closed loop stimulation algorithm, capable of adapting heart rate in response to physiological demands independent of movement or respiration, Biotronik said. “The FDA has approved CLS as […]
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
Delcath (NSDQ:DCTH) said today it won Orphan Drug Designation from the FDA for melphalan, used in its hepatic delivery system to treat cholangiocarcinoma. Orphan drug designations are bestowed by the FDA on treatments for “orphan diseases”, usually defined as conditions that affect fewer than 200,000 people nationwide. The designation comes with benefits, such as tax credits, exclusivity […]
On Friday, an op-ed by 2 prominent cardiologists published in The New York Times heavily criticized the FDA’s handling of medical devices, writing that the 21st Century Cures Act, recently passed by the U.S. House of Representatives, would “severely weaken, not strengthen, the FDA’s already ineffective regulatory scheme for medical devices.” Written by Dr. Sanket […]