The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving ...

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

The agency accused the Germany-based firm of selling multiple saliva-based ELISAs without appropriate marketing authorizations, among other violations.

Commenting on its court win, the AMP said at the time: “If it had been left in place, the FDA’s Final Rule would have classified LDTs as medical devices, creating unwarranted regulatory ...

Mastering FDA Cybersecurity Blue Goat Cyber joins DeviceTalks Minnesota to showcase expert strategies for FDA-rea ...

In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

In a groundbreaking advancement for the orthopedic device industry, Sawbones and Numalogics, Inc. are proud to announce that ...