ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA updates its artificial intelligence/machine learning approval stats, a newly cleared insomnia app will test oncoming reimbursement codes for digital therapeutics, China drafts a standard defining real-world data terminology, and more updates from the UK, Switzerland, and Italy.
Digital Health Picks
FDA AI approvals. FDA authorized 61 devices enabled by artificial intelligence/machine learning in April through June of this year, according to the agency’s latest update of its AI/ML-enabled device database. That’s an increase from the 46 AI/ML devices authorized in the first three months of 2024, leading to total of 950 AI/ML devices authorized as of June 30, FDA says. A large majority of the listed devices are cleared via the 510(k) route and most are used to help analyze imaging scans.
