Devices · Cardiosense, Inc.

PCWP Analysis Software

Cardiosense, Inc. is listed for PCWP Analysis Software (DEN250057). The FDA list gives May 22, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SIF as “Software Device System For Estimation Of Cardiac Pressures”: This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250057

Official FDA database record

Date of final decision

May 22, 2026

Company on the FDA list

Cardiosense, Inc.

Lead panel

Cardiovascular

Primary product code

SIF

openFDA device name for the code

Software Device System For Estimation Of Cardiac Pressures

Device class

2

Regulation number

870.1150

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned