The regulator authorized the company to keep its e-cigarettes on the U.S. market after a federal ban in 2022 had pushed it to ...

The FDA cleared an artificial intelligence (AI)-powered wristband (Felix NeuroAI) to treat upper-limb functional limitations in adults with essential tremor, device maker Fasikl announced. The ...

University of Minnesota spinout Fasikl has obtained an FDA clearance for its artificial-intelligence-powered wearable for people with essential tremor. | The company’s Felix NeuroAI Wristband ...

Newly-cleared technology is a game changer for the diagnosis of an often debilitating disease. MILPITAS, CALIFORNIA / ACCESS Newswire / July 2, 2025 / ID-FISH Technology, Inc., a leading provider of ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.

By Dean Seal Shares of Instil Bio jumped after federal regulators cleared the investigational new drug application for its tumor treatment AXN-2510.

Fasikl’s portfolio includes the FDA-cleared Felix™ NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface. To learn more, visit fasikl.com.

The post This FDA-Cleared Device, Which Aims To Reduce Traumatic Brain Injury, Was Worn By Sauce Gardner During The 2024 NFL Season appeared first on AfroTech.

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food ...

The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a ...

Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is used for helping neurosurgeons make clinical decisions. Cirrus uses ...