The FDA finalized a rule April 29 to treat laboratory-developed tests as medical devices, putting them in the purview of federal oversight. Under the new rules, the FDA will phase in oversight of ...

The laboratory sits at a unique position in a patient’s diagnostic journey. The information that’s generated from a laboratory test is the critical link between a patient with a medical question and a ...

Reesha Ahmed was on cloud nine. It was January and Ahmed was at an OB-GYN’s office near her home in Venus, Texas, for her first prenatal checkup. After an ultrasound, getting anti-nausea medication, ...

A hospital, a laboratory, three lab employees, a referring physician and his office manager will collectively pay more than $7.2 million to settle allegations that they defrauded government healthcare ...