surgical robots

The US Food and Drug Administration has issued draft guidance for surgical robots, outlining its thinking for developers and manufacturers of robotic surgical systems. The document is expected to shape regulatory expectations in a growing medtech field, and industry stakeholders will likely be able to comment before a final version is adopted.

The US Food and Drug Administration has issued draft guidance for cardiovascular surgical robots, outlining the agency's current thinking on the development and review of robotic systems used in cardiac and vascular procedures. The document gives manufacturers and clinicians a framework to follow, and a public comment period typically allows stakeholders to give feedback before the guidance is finalized.