<p>➀ Researchers highlight the growing gap between autonomous AI agents' capabilities and existing medical device regulations in the U.S. and Europe, emphasizing patient safety concerns;</p><p>➁ Proposed solutions include short-term enforcement adjustments, voluntary alternative approval pathways (VAPs), and long-term regulatory frameworks resembling medical professional qualifications;</p><p>➂ Collaboration among regulators, healthcare providers, and developers is deemed critical to enable safe AI innovation while maintaining adaptive oversight.</p>