Cardiovascular · De Novo · 2026
PCWP Analysis Software
Cardiosense, Inc.. Granted by FDA on 22 May 2026 under submission DEN250057, product code SIF (software device system for estimation of cardiac pressures). What FDA's record says, in FDA's words.
Device record · DEN250057
- Device. PCWP Analysis SoftwareDEVICE
- Company. Cardiosense, Inc.COMPANY
- Decision. 22 May 2026, De NovoDECISION
- Panel. CardiovascularPANEL
- Product code. SIF, Software Device System For Estimation Of Cardiac PressuresCODE
- Regulation. 21 CFR 870.1150, Class IIREG
- Source. FDA database entry · decision document (5 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
PCWP Analysis Software is intended to noninvasively estimate pulmonary capillary wedge pressure (PCWP) and identify patients with a PCWP above or below 18mmHg, for patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and New York Heart Association (NYHA) Functional Class II, III, IV symptoms. The hemodynamic data will be used by qualified healthcare professionals in conjunction with other standard of care parameters to evaluate heart failure patients. The results of PCWP Analysis Software are intended to be used under the supervision of a qualified healthcare professional in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the qualified healthcare professional's judgment. Patient management decisions should not be made solely on the results of the PCWP Analysis Software. The device is only for prescription use. FDA concludes that this device should be classified into Class II. This order, therefore, classifies the PCWP Analysis Software, and substantially equivalent devices of this generic type, into Class II under the generic name software device system for estimation of cardiac pressures. DEN250057 - Arezou Azar Page 2 FDA identifies this generic type of device as: Software device system for estimation of cardiac pressures. A software device system for estimation of cardiac pressures is a prescription-only device that uses software algorithms to analyze one or more non-invasive physiologic signals or […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SIF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SIF, in Cardiovascular, or granted in 2026. The whole record is at FDA AI-enabled medical devices.
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