Page 4 - William Maisel News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Reclassification to higher risk category was years in the making

Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.

[author: Heather Hatcher, Ph.D.] A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created ...

POLITICO Get the Prescription Pulse newsletter Email Sign Up By signing up you agree to receive email newsletters or updates from POLITICO and you agree to our privacy policy and terms of service. You can unsubscribe at any time and you can contact us here. This sign-up form is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Presented by Pharmaceutical Care Management Association With Lauren Morello and Sarah Owermohle. On Tap — U.S. is now sequencing six percent of Covid-19 cases. — FDA rebuts Trump-era proposal to deregulate review of many medical device...

‘False sense of security’: Study finds some thermal imaging temperature checks show inaccurate readings By Kelly Hayes What we know about children and COVID-19 vaccines When will children be able to get COVID-19 vaccines? It depends on the child's age, but some teenagers could be rolling up their sleeves soon. Since the onset of the coronavirus pandemic, many people have undergone thermal imaging temperature checks at schools, airports, workplaces and even sports venues — part of a larger approach to help lower the risk of COVID-19 in these public areas. But researchers behind a n...