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Medical device regulatory submissions with computational modeling evidence should include data proving the models’ credibility, the FDA advised in a new draft guidance. Read More
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a confirmation vote on Biden’s pick to lead the nation’s medical device regulator. Read More
The Centers for Medicare and Medicaid (CMS) has expanded Medicare Part B coverage of continuous glucose monitors (CGMs) and some other kinds of durable medical equipment (DME). Read More
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