The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

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

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

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

With $10 million in new funding, Teal Health co-founder Kara Egan shares how her cervical cancer testing startup intends to reach its first patients.

Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

An FDA optometry roundup discusses changes in drug approvals and devices used by optometric eye care professionals.

The FDA has issued a revised guidance on medtech manufacturers' obligations to notify the agency of manufacturing ...

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...

The brand that put microcurrent tools on the map just launched the NuFace FixMicroWand, designed for the younger generation ...