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 ...

Cytovale has developed a FDA-cleared, rapid diagnostic tool for sepsis, and it just raised $100 million to roll it out to hospital systems across the country. Every year, over 1.7 million Americans ...

A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical devices, striking down the agency’s recently finalized rule. The decision, ...

This article was reviewed by Darragh O’Carroll, MD. Pros, Cons & Benefits of At-Home Lab Testing You probably don’t have time (or want to) to sit … ...