FDA Clears Keya Medical's Coronary CTA Analysis Software

Keya Medical received FDA clearance for a coronary CT angiography (CCTA) analysis software. No details on specific intended use, performance, or predicate device were provided in the source snippet.

• Clearance announced by Keya Medical, as reported by AuntMinnie; specific software name and functionality not detailed in the announcement snippet.
• FDA 510(k) clearance allows marketing in the U.S.; no clinical performance data or comparator information was included.
• Further details regarding algorithm type (e.g., AI-based FFR/plaque analysis) remain undisclosed in this initial report.

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