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;

➁ Proposed solutions include short-term enforcement adjustments, voluntary alternative approval pathways (VAPs), and long-term regulatory frameworks resembling medical professional qualifications;

➂ Collaboration among regulators, healthcare providers, and developers is deemed critical to enable safe AI innovation while maintaining adaptive oversight.