Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.

As AI technology evolves rapidly, the FDA ... the Software Precertification Pilot, which allows continuous assessment of AI products. The risk-based approach to regulating AI-enabled medical ...

Data drift can affect the accuracy and reliability of predictive models.” FDA explains that AI-enabled medical products can experience data drift due to statistical differences between the data ...

A picture may be worth a thousand words, but they both have a lot of work to do to catch up to BiomedGPT. A Lehigh University ...

Following observations that Elvidys led to significant improvements in creatine kinase levels ... FDA has authorized a total of 950 Artificial Intelligence and Machine Learning (AI/ML)-Enabled ...

Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices ...

“AI-enabled plaque software ... UCLA Medical Center. “This has great implications for patient care and improved outcomes, being able to match intensity of treatment with level of risk.” ...

NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, announced the launch of Software-Enhanced Drug ...

The US’ Food and Drug Administration (FDA) has approved Journey Medical’s Emrosi, the brand name for its 40mg minocycline hydrochloride extended-release capsules, to be used in the treatment ...