- Device
- PCWP Analysis Software
- Company
- Cardiosense, Inc.
- Submission number
- DEN250057
- Pathway
- De Novo
- Decision date
- May 22, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- SIF
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.