Today (10/2) the U.S. Food and Drug Administration (FDA) announced the rejection of Ryoncil, a treatment for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients. For patients with the most aggressive form of SR-aGVHD, the mortality rate...
According to an analysis published in JAMA Internal Medicine, almost half of the Medical Device Reports (MDRs) were directly from the Medical Device Safety Communications (MDSC) sent by the U.S. Food and Drug Administration (FDA). From this report, it was more clear...
Today (9/30) the U.S. Food and Drug Administration (FDA) granted clearance for leading visualizations for surgical procedures provider, SentiAr’s holographic cardiac ablation system Command EP. This will be the first holographic guidance system to be used in an...
On Friday (9/25), the Centers for Medicare & Medicaid Services (CMS) published a revised guide to expedite the process in which laboratories receive approval for COVID-19 testing. To aid in combatting the novel virus, the CMS program’s goal is to eliminate the lag...
Today (9/28), Hologic received emergency use authorization (EUA) from the FDA for their testing kit for individuals with no symptoms of COVID-19. The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and...
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
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