Medical devices are known to be iterative, but so are FDA guidances, and the 2018 draft guidance for third-party review of 510(k) applications was the second such document in two years. The 2020 final guidance made another adjustment or two based on feedback from industry, including a specific note that the intent of the guidance is to eliminate any need for routine FDA re-review of 510(k)s reviewed by third parties.

LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.

Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.

The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.

Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.

Neuronetics Inc., of Malvern, Pa., has won U.S. FDA breakthrough device designation for its Neurostar transcranial magnetic stimulation (TMS) device for the treatment of patients with drug-resistant bipolar depression. The news comes as the company reported a strong fourth quarter for 2019, with revenue up 11% year-over-year to $17.4 million.