On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

which received Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA") in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential ...

A federal judge will soon decide whether to dismiss a lawsuit against UnitedHealth Group alleging that the company and its ...

The proposed legislation, sponsored by Rep. David Schweikert (R-Ariz.), would amend the Federal Food, Drug, and Cosmetic Act ...

Scott Gottlieb, the Food and Drug Administration commissioner during the first Trump administration, called for the agency to ...

It doesn't mean you shouldn't use other resources," Williams said. Eve Wellness' FDA-approved AI technology captures up to 2,000 images per exam, which is particularly useful for women with dense ...

In the last year, the FDA approved more than 900 AI technologies ... and have a ‘human in the loop’ to assure and maintain algorithms,” Bhargava said. “Doctors should be at the table ...