The FDA has implemented a final order requiring artificial intelligence-enabled radiology software to obtain agency clearance before being marketed in the U.S. This decision follows the denial of a petition from Harrison.ai, which sought an exemption from the traditional 510(k) premarket-notification process for certain radiology tools. The FDA emphasized that premarket clearance is necessary to ensure safety and effectiveness, requiring manufacturers to demonstrate that their products are substantially equivalent to existing approved devices. This regulatory process poses challenges for AI software companies, which must navigate frequent updates and maintain compliance, as health systems and investors need to be aware of what versions are cleared for use. The FDA expressed a commitment to exploring more innovative regulatory approaches in the future.
Thu, 17 Sep 2026 15:16:01 GMT | PYMNTS.com