The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...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The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...

Federal health officials are backing the health benefits of nicotine pouches, ruling that Philip Morris International’s Zyn ...

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

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

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

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

TL;DR: The Fat Iron Pro for $297.99 is designed to reduce the appearance of cellulite, wrinkles, and body fat. Spending a ...