Regenerative medicine firm Vivex Biologics navigates complex FDA approval landscape
Vivex Biologics chairman John McCallum breaks down the challenges, costs, and strategies behind bringing medical innovations ...
Fierce Pharma12h
Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
Fierce Biotech7d
FDA's novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
Withings $150 blood pressure monitor is FDA approved and out now
Withings . Withings has announced its BPM Vision blood pressure monitor will be available in the U.S. from April 2, having cleared the Food and Drug Administration (FDA)’s strin ...
Fierce Biotech2d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
The Cairns Post1mon
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor is executing a modular review process with the FDA, whereby modules covering ... is involved due to the number of devices for which we are seeking approval simultaneously.