Medmarc Blog (blog.medmarc.com)
Artificial Intelligence
FDA Product Centers Collaborate on AI Draft Guidance
The U.S. FDA posted a draft guidance for AI-enabled device software functions (DSFs) in January 2025, which provides much-needed clarity for a number of product types. All three of the agency’s...
AI Regulation Lagging Behind Innovation and Creating Friction
Developers of artificial intelligence (AI) products have moved quickly into a wide range of product types, but regulatory agencies are struggling to keep pace. One of the issues for industry is that...
H.R. 1 Restores Deductibility of Research and Development Expenses
Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...
FDA Finalizes Guidance for AI Predetermined Change Control Plans
The FDA has published the final version of a guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI) software. The final guidance is limited in terms of scope, but...
FDA Appoints New Director for Center for Devices
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as...
Mammography False Positives Endanger Screening Compliance
A new study published recently in the Annals of Internal Medicine disclosed an association between false positive results on mammography screening exams and a reluctance to return for screening....
AdvaMed and CapView Propose Plan for Medicare Coverage of AI
The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...
FDA Releases Action Plan for AI | Medmarc
The FDA announced an action plan for artificial intelligence in mid-January, which comes across largely as a follow-up to a discussion paper the agency posted in April 2019. The plan lays out a...