vCLAS Cryoablation System — Regulatory decision
Late 2026
2. FDA Approval of vCLAS 1st generation ULTA technology Expected by Year End 2026Source filing
ADGM biotech catalysts & pipeline
ADAGIO MEDICAL HOLDINGS INC · Data as of 2026-09-08
Upcoming catalysts
vCLAS Cryoablation System — PDUFA
Oct 2026–Mar 2027
PMA Approval Q4 2026 / Q1 2027Source filing
vCLAS Cryoablation System — PDUFA
Q1 2028
PMA Approval Q1 2028Source filing
vCLAS Cryoablation System — Regulatory decision
Early 2028
3. FDA Approval of vCLAS Ultra next-gen ULTA technology Expected by Early 2028Source filing