AI Highlights™ — PDUFA
Q3 2026
Anticipate FDA clearance of AI Highlights™ by the end of the third quarter of 2026, with U.S. commercial launch expected shortly thereafter.Source filing
CV biotech catalysts & pipeline
CAPSOVISION INC · Data as of 2026-09-08
Upcoming catalysts
CapsoCam Plus — Regulatory decision
Q3 2026
We anticipate obtaining FDA clearance by the end of the third quarter of 2026 with commercialization planned to begin in US shortly thereafter.Source filing
second-generation of CapsoCam Colon — NDA/BLA submission
Q3 2026
Pipeline programs progressing as planned, including our second-generation of CapsoCam Colon with 510(k) submission expected in the third quarter of 2026, and initiation of a clinical study for CapsoCam UGI in pancreatic cancer detection with the first patient enrolled in May 2026.Source filing
CapsoCam Colon™ — NDA/BLA submission
Q4 2026
Pipeline continues to advance with CapsoCam Colon™ on track for 510(k) submission in the fourth quarter of 2026, with ongoing enrollment in the CapsoCam UGI clinical study for pancreatic cancer detection.Source filing