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High-risk “class D” in vitro diagnostics (IVDs) should get specialized handling from their manufacturers and the third-party notified bodies authorized to approve them on behalf of the EU, said the Medical Device Coordination Group (MDCG), which is made up of experts appointed by EU member states. Read More
Dyad Medical’s Libby IAAA automatically does sensitive in vivo (within the heart) assessments for preclinical and clinical evaluations to optimize the design of the drug-eluting stents used to treat coronary artery disease. Read More
Medical diagnostic test developer Cleveland Diagnostics has received a Form 483 for deficiencies observed during an FDA inspection of the company’s facility in Cleveland, Ohio, last November. Read More
The best way for Congress to help the FDA address its concerns about reports of a high level of false-positive results from noninvasive prenatal testing (NIPT) is to pass new legislation, the FDA said in a Feb. 11 letter to lawmakers. Read More
According to AdvaMed, the diagnostics industry has shipped approximately 800 million COVID-19 tests to laboratories across the country since March 2020, as well as more than 1 billion at-home tests. Read More
San Francisco, Calif.-based Sirona Medical has acquired two FDA-cleared products from Nines, another California radiology software developer, expanding its portfolio of products that use artificial intelligence (AI) for analysis of radiographic images. Read More