Signify Premium Insight: Headwinds Abound as AI Vendors Seek Seal of Approval

Signify Research has recently updated its AI regulatory database, which tracks the number of AI solutions that are cleared for use by the various regulatory bodies across the world. The number of regulatory submissions has continued to grow rapidly from 2021’s report, with vendors across the globe increasingly readying their solutions for hospital sales, and regulators increasingly acquiescing to their submissions. Since 2016, there were a similar number of CE Mark (189 AI algorithms) as there were US-FDA clearances (192); however, the number of NMPA Class III (China) approvals lagged significantly (17), with the first only issued in early 2020.