PCWP Analysis Software is an AI-enabled medical device from Cardiosense, Inc., listed by FDA (De Novo, DEN250057) with a decision date of 2026-05-22. Review panel: Cardiovascular.
| FDA submission number | DEN250057 |
|---|---|
| Pathway | De Novo |
| Company | Cardiosense, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2026-05-22 |
| Decision | Unknown |
| Product code | SIF |
| Classification | Software Device System For Estimation Of Cardiac Pressures |
| Device class | 2 |
| Regulation number | 870.1150 |
| Review time (calendar days) | 186 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.