Unlike traditional software systems that rely on deterministic rules, artificial intelligence devices frequently use ...

World’s First Class III Approval for a Breakthrough Medical Imaging AI: Diagens AI AutoVision® Passes Highest-Level ...

As healthcare providers prioritize efficiency, accuracy, and scalable patient care delivery, AI-enabled devices are increasingly viewed as essential operational infrastructure rather than emerging ...

Securing coverage, coding, and payment - the building blocks of healthcare reimbursement – can challenge any device manufacturer’s ability to launch medical devices in the U.S. Add a digital component ...

For nearly a decade, the promise of artificial intelligence in medicine has oscillated between revolutionary breakthrough and overhyped disappointment. But as of May 2026, the narrative has shifted ...

Paragon Health Institute, a leader in health care research and market-based policy reforms, has published Generalization Uncertainty in AI-Enabled Medical Devices: A Safer Way Forward, a major ...

Editor's note: This article was updated on 22 November 2024 to correct a word in a quote by Michelle Tarver. The inaugural meeting of its digital health advisory committee gave the US Food and Drug ...

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...

The digital health market is undergoing rapid transformation driven by the fast development of artificial intelligence. AI is ...

In a downbeat year for health care stocks, look for AI to boost these sector names in the second half of 2026.