On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...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

Cleveland Clinic researchers are using artificial intelligence to identify existing FDA-approved drugs that may be repurposed to treat other complex diseases. The effort is led by Feixiong Cheng, PhD, ...

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

The FDA has approved nearly a thousand artificially ... look at the performance of a model of an algorithm, AI-enabled or not, when it’s deployed.” Perhaps the most common AI product in ...

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

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 ...

to conduct Ainnova's upcoming clinical studies to seek approval from the U.S. Food and Drug Administration (FDA) for Ainnova's Vision AI platform. Fortrea will assist Ainnova in requesting a pre ...