Hannah Daniel
Reporter
Latest From Hannah Daniel
Joint AI/ML Risk Management Guidance Brings FDA Standard To UK
A collaborative document by a US and British organizations brings FDA-approved AI/ML risk management standards to the UK.
FDA Encourages Voluntary Device Shortage Reporting After PHE End
The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.
Digital Health Roundup: HIMSS, Cardio Conversations, ChatGPT And New FDA Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm, and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.
FDA, CDER Discuss AI/ML In Drug Development In Discussion Papers
FDA hopes to engage in “mutual learning” with stakeholders to develop new regulations for the use of AI/ML drug development.
Industry Leaders Urge Congress, CMS To Expand Coverage Of Breakthrough Devices
Medtech leaders urged Congress to ensure coverage of breakthrough devices during a hearing by the House Ways and Means Subcommittee on Health.
News We’re Watching: Cancer Screening Partnership, New Abbott Electrophysiology Head, V-Champs AI Challenge
This week, Bioventus announced plans to sell its wound business; Pfizer and Thermo Fisher Scientific partnered to increase cancer screening access; and the FDA expanded the magnetic resonance imaging labeling for Abbott’s Eterna spinal cord stimulator.