PCWP Analysis Software is an AI-enabled medical device from Cardiosense, Inc. that the U.S. FDA granted through De Novo DEN250057 on May 22, 2026. Its lead review panel is Cardiovascular and its primary product code is SIF (Software Device System For Estimation Of Cardiac Pressures).
See also FDA-cleared AI cardiovascular devices in 2026, all FDA AI clearances in 2026, top cardiovascular AI devices.
Key facts
| Submission number | DEN250057 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Cardiosense, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | SIF — Software Device System For Estimation Of Cardiac Pressures |
| Applicant (openFDA) | Cardiosense, Inc. |
| Applicant location | Chicago, IL, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1150 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. PCWP Analysis Software went through this pathway (DEN250057).
openFDA lists it as a Class 2 device under 21 CFR 870.1150. Class II devices are moderate risk and are subject to general and special controls.
Product code SIF covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Cardiosense, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.