Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

Focus: Medical device software regulation under the EU MDR, EU IVDR, and FDA, including clinical validation, regulatory positioning, and compliant software development Decisions made during medical ...

On October 21, 2026, the U.S. Food & Drug Administration (“FDA”) published final guidance titled “Regulatory Considerations for Prescription ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations (June 22nd - June 26th, 2026)" training has been added to ...

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...

Artificial intelligence may be revolutionizing sepsis detection and diagnosis, but can we trust it without strong regulatory guardrails? As AI/ML-enabled medical devices rapidly evolve, IPs must stay ...

The U.S. Food and Drug Administration says certain AI-enabled "low-risk" health devices and clinical decision support software won't face agency's regulatory scrutiny. (Image: FDA) New artificial ...

The federal government issued a discussion paper Tuesday as it seeks feedback on regulating certain artificial intelligence-enabled medical devices.

This week the US House of Representatives' Energy and Commerce Committee's subcommittee on Health held a hearing to discuss the "Federal Regulation of Mobile Medical Apps and Other Health Software", ...