Labcorp – a global life sciences and healthcare company – is set to close a Massachusetts lab and lay off dozens of workers.

The chief medical officer is interested in an easier path to market for health screening features in wearable devices.

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Singular Health has jumped a major regulatory hurdle after winning fast-tracked FDA clearance in the US for its 3DICOM MD ...

The Bethlehem-based maker of at-home diagnostic tests said it submitted two separate applications to the FDA at the end of ...

The Union health ministry has notified recruitment of two more drug inspectors in the drug regulatory authority to execute the responsibilities under the Drugs and Cosmetics Act, 1940. The Ministry ...

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device ...

The expanded 510 (k) clearance is publicly available in the FDA's 510 (k) Premarket Notification database under device number K253939.

KORU Medical aims to broaden FreedomEDGE use beyond immunoglobulin indications to reach the oncology infusion centre market.

Clearances with a Generative AI Model SubmissionCOLUMBIA, Md.--(BUSINESS WIRE)--Welldoc®, a leader in AI-powered cardiometabolic health solutions, today announced the submission of a 510(k) ...

Spokeo reports digital business cards modernize contact sharing, offering ease and efficiency for networking in a digital age ...

LAREDO, Tex. (KGNS) - In the early morning hours of today at 12:38 a.m., the Laredo Police Department received an emergency ...