FDA SaMD regulation requirements explained: learn what evidence the FDA expects for clearance, from clinical validation and risk controls to cybersecurity and usability.

Surgical navigation systems with optical tracking in spine surgery can be highly accurate—but only with strong registration, stable reference frames, and disciplined workflows. Learn what really determines performance.

FDA Tightens SaMD Path for AI Diagnostic Software: learn how new FDA algorithm traceability rules may delay 510(k) and De Novo submissions, raise compliance workload, and impact U.S. export planning.

FDA Tightens SaMD Rules for AI Sleep Apnea Monitors: learn how new FDA guidance affects 510(k), De Novo, edge-device validation, and export market access for manufacturers.