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Labcorp is buying Personal Genome Diagnostics for up to $575 million, gaining the Baltimore, Md.-based company’s elio range of liquid biopsy and tissue-based products. 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
Quidel is adding one of the world’s largest in vitro diagnostics companies to its already considerable diagnostics portfolio with the $6 billion purchase of Ortho Clinical Diagnostics. Read More
High-quality evidence was lacking for most of the COVID-19 diagnostics, medical devices and drugs the FDA has granted Emergency Use Authorization (EUA) since the start of the pandemic, claimed researchers at Israel’s Tel-Aviv University in a provocative analysis in the journal JAMA Internal Medicine. Read More