At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

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

Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris ...

Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...

The new approach is designed to create a connection between the left and right atrial chambers of the heart in a single ...