Unlike the failed Theranos company that ended up being a scam, BetterWay does not test the blood in shoebox-size equipment.

A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

State PH Lab in Kerala develops molecular test kits to identify toxic amoeba causing fatal brain infection, saving lives.

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, ...

The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, ...

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision ...

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, ...

Researchers developed a wearable pad that detects inflammation and cancer biomarkers in menstrual blood using smartphone ...

An interdisciplinary research team from the Allergology and Veterinary Medicine Divisions at the Paul-Ehrlich-Institut (PEI) ...

A team of scientists at NYU Abu Dhabi has developed a breakthrough paper-based diagnostic device that can detect COVID-19 and ...