On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...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

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 ...

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 ...

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 ...

DermaSensor’s AI algorithm was developed and trained on ... and New Zealand. Getting FDA approval was a long process – an earlier, bulkier version of the device was first submitted back ...

Eko sells a range of digital stethoscopes and already has two FDA-approved AI algorithms for other cardiac features, one for atrial fibrillation (AF) and another for structural murmurs associated ...