The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...

Cleveland Diagnostics, a biotechnology company co-founded by Cleveland Clinic in 2013, announced it has secured FDA clearance for its first cancer-detection kit. The company’s product, called IsoPSA, ...

Swiss-based Roche announced this month that it has received U.S. regulatory clearance for a less-complex vitamin D test in the United States, which the company said opens the door to more efficient ...

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

BUFFALO, N.Y. – The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the University at Buffalo School of Nursing’s wet ...