FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...

Management of healthcare shipments requires not only logistics expertise but also a deep understanding of regulatory ...

The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

Harrison.ai submits FDA petition to increase US access to innovative radiology AI while maintaining appropriate safeguards.

In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over complaints handling.

The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Nov 13, 2025)" training has been added to ResearchAndMarkets.com's offering. cGMP or current good manufacturing practices are ...

At The Constellation Forum 2025 in New York, Gottlieb said there are and will continue to be challenges regulating software when it comes to AI devices.

The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.