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Rapidly evolving federal guidance for people who have been exposed to COVID-19 or who have already tested positive is expected to further increase the demand for scarce diagnostic tests. Read More
In a momentous court decision for a failed diagnostic test developer, Elizabeth Holmes, former CEO of Theranos was convicted on four counts of defrauding investors in the U.S. District Court for the Northern District of California on Monday. Read More
A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) has reclassified several class III devices, rated as highest-risk, to the lower-risk class II category. Read More
DSAART, a devicemaker doing business as Alpha Aesthetics, failed to investigate numerous complaints about its silicone facial and body contouring implants, the FDA said in a warning letter to the Carson City, Nev.-based company. Read More
FDA-authorized antigen tests for the virus that causes COVID-19 appear to work for the omicron variant but they may have less sensitivity for identifying positive samples, the agency said. Read More
The FDA has released final guidance detailing the core components of nonclinical testing and clinical trials of benign prostatic hyperplasia (BPH) devices, citing the condition’s prevalence in older male populations. Read More
The FDA is receiving more than 100 applications for pre-Emergency Use Authorization (EUA) meetings and full EUA status for in vitro diagnostics (IVD) each month, so it expects to receive more than 1,000 such submissions in 2022. Read More
The FDA has issued a draft guidance explaining how it defines and distinguishes “counterfeit” devices from the genuine article, as part of its implementation of the Safeguarding Therapeutics Act enacted Jan. 5. Read More
The FDA is looking to regularize the status of devices it has authorized for emergency use during the COVID-19 pandemic and has released two draft guidances — one explaining the transition away from emergency status and another on how the agency’s approach to enforcement will change for the affected devices. Read More