FDA Safety Alert – Stereotactic Navigation Systems

FDA issued a Safety Alert to users of Stereotatic Surgical Navigation Systems. This alert provides a vareity of warnings and recommmendations to prevent deaths and serious injuries when using these systems including software issues and medical imaging issues among others. The full alert is at the link provided.

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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

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