The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to […]
FDA
CDRH director Shuren says flexibility remains key as COVID-19 strains regulatory system
Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), believes the level of flexibility shown by the FDA during the COVID-19 pandemic may be needed in a post-pandemic world. Speaking in a town hall event at The Virtual Medtech Conference hosted by AdvaMed, Shuren outlined the work the FDA has put […]
FDA’s Hahn insists a COVID-19 vaccine approval will not be rushed
FDA Commissioner Dr. Stephen Hahn used a virtual conference appearance today to repeat that a COVID-19 vaccine approval will be up to the agency’s scientists — not political pressure. “We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held […]
FDA clears Haemonetics’ plasma collection system
Haemonetics (NYSE:HAE) announced that it received FDA 510(k) clearance for its NexSys PCS system with Persona technology. Boston-based Haemonetics’ new, proprietary Persona technology customizes plasma collection based on an individual donor’s body composition, according to a news release. NexSys PCS (plasma collection system) with Persona is intended for use as an automated cell separator system and […]
FDA labels another BD Alaris recall Class I
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris pump module is Class I, the most serious kind. BD Alaris pump module model 8100 and the Alaris pump module door assembly replacement kits (part numbers 49000346, 49000239, 49000438 and 49000439) were included in the Aug. 4 recall. Those models and parts were […]
LabCorp molecular COVID-19 testing method wins FDA EUA
Laboratory Corporation of America (NYSE:LH) announced today that received FDA emergency use authorization for its new COVID-19 testing method. Burlington, N.C.-based LabCorp’s new, high-throughput method uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing in an effort to improve the speed and efficiency of RT-PCR tests for the virus, according […]
Report: FDA expanding AstraZeneca vaccine probe
The U.S. FDA is reportedly expanding its probe into a serious illness arising in the COVID-19 vaccine study from AstraZeneca (NYSE:AZN). This news, reported by Reuters, follows last week’s statement from U.S. Health and Human Services Dept. Secretary Alex Azar that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in […]
FDA authorizes first oral-rinse COVID-19 diagnostic
Access Genetics & OralDNA Labs announced today that it received FDA emergency use authorization (EUA) for its oral-rinse COVID-19 test. Eden Prairie, Minn.-based Access’ OraRisk COVID-19 RT-PCR test allows for testing from a saline oral rinse collection. Samples of the test are viable for up to 72 hours and don’t require cold pack transportation while […]
Federal rule on ethylene oxide now delayed until 2021
The final federal rule limiting ethylene oxide (EtO) emissions from commercial medtech sterilization plants is now set to come out in 2021, according to the Environmental Protection Agency. Before the COVID-19 pandemic struck, the EPA had expected to issue the rule in May 2020. The agency considers ethylene oxide a carcinogen, and EtO emissions have attracted national […]
Cepheid wins EUA for COVID-19, flu, RSV combination test
Cepheid announced today that it received FDA emergency use authorization for its Xpert Xpress SARS-CoV-2/Flu/RSV diagnostic test. The Danaher Corp. (NYSE:DHR) subsidiary’s rapid molecular diagnostic test for detecting the viruses causing COVID-19, Flu A, Flu B and RSV infections in a single patient can be used in tandem with any of Cepheid’s GeneXpert systems across the […]
FDA allows at-home capsule endoscopy administration
CapsoVision announced that it received FDA enforcement discretion to allow at-home administration of its CapsoCam Plus. Saratoga, Calif.-based CapsoVision’s CapsoCam Plus is a small bowel capsule endoscope intended for the visualization of the small bowel mucosa in adults. It does not require external equipment to be worn by the patient and it can be returned […]