ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA details expectations for surgical robots and plans for the future; Anthropic, OpenAI add heft to AI cardiologist initiative; Google recruits; FDA seeks more advisory panelists; World Health Organization expands device focus; Singapore introduces premarket checklist; Medicare considers hepatitis C screening coverage; and more global updates.
Digital Health Picks
FDA eyes robot evolution
The agency laid out its submission expectations for established categories of surgical robotics in a draft guidance on Friday, and it plans to look more into the future for the technology at an upcoming workshop.
The draft ticks through what FDA wants to see in applications for robotically assisted surgical devices (RASDs), including bench testing, software validation, training and human factors activities, as well as data from animal and clinical studies. The draft focuses on robots that are teleoperated by onsite surgeons, and explicitly “does not address remotely teleoperated RASDs, or autonomous robots that perform significant aspects of operative procedures independent of qualified practitioners.”
In parallel to publishing the guidance, however, FDA scheduled a two-day workshop to consider those next technological advancements. The December 2-3 gathering will seek insights on “evaluating benefit-risk in robotic medical devices with autonomous or remote teleoperation capabilities.”
