Products

PCWP Analysis
Cardiosense
Cardiology AI
Cardiosense's FDA-cleared AI tool noninvasively estimates pulmonary capillary wedge pressure (PCWP) using a wearable sensor, providing real-time insights for proactive heart failure management.

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About Cardiosense

Cardiosense is a digital health company that develops AI-powered cardiac monitoring technology to detect early signs of heart disease and facilitate personalized therapy. Their platform leverages wearable sensing technology, advanced signal processing, and deep learning to convert raw physiological data into clinical intelligence. The company’s primary medical-grade wearable monitor, CardioTag, is designed to noninvasively capture three distinct physiological signals: electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG). This multimodal sensor integration, combined with AI-driven digital biomarkers, provides comprehensive cardiac assessment capabilities.

Cardiosense’s initial focus is on improving heart failure management. Their CardioTag device and PCWP Analysis Software™ recently received FDA De Novo classification, enabling non-invasive estimation of Pulmonary Capillary Wedge Pressure (PCWP) at the point of care. This technology aims to provide clinicians with real-time, objective hemodynamic insights, allowing for more precise and proactive management of heart failure patients, potentially reducing hospitalizations and optimizing medical therapy. The company’s approach is to provide timely clinical decision support across various care settings, including emergency department assessment, inpatient management, discharge planning, and outpatient/at-home monitoring.

Focus Areas

cardiac monitoring heart failure management AI in healthcare wearable technology digital biomarkers remote patient monitoring cardiovascular disease detection

Business Intelligence

TechnologyAI platform leveraging wearable sensing technology, advanced signal processing, and deep learning to convert raw physiological data into clinical intelligence. Cloud-native approach for data aggregation and analysis.

What Physicians Need to Know

Specialization
Cardiosense specializes in leveraging wearable technology, signal processing, and deep learning to diagnose and assess cardiovascular diseases, with a primary focus on heart failure management.
Key Differentiator: Noninvasive PCWP Estimation
Cardiosense offers the first and only noninvasive heart failure monitoring solution to determine Pulmonary Capillary Wedge Pressure (PCWP) at the point of care. This is a critical indicator of fluid buildup that traditionally required invasive catheterization.
Key Differentiator: Multimodal Wearable Sensor
Their CardioTagu2122 device is a multimodal wearable sensor that noninvasively captures seismocardiogram (SCG), electrocardiogram (ECG), and photoplethysmogram (PPG) signals, along with heart and pulse rate. This comprehensive data input is crucial for developing advanced AI models for cardiovascular parameters.
Technology Stack
Cardiosense's AI platform converts raw physiological data into clinical intelligence using advanced signal processing and deep learning techniques. Their CardioTagu2122 device is a key part of this, capturing multiple physiological signals. Some related projects or descriptions mention the use of XGBoost for risk assessment.
FDA Authorizations
Cardiosense has received FDA De Novo classification for its PCWP Analysis Softwareu2122 and 510(k) clearance for its CardioTagu2122 wearable heart monitor. They also received FDA Breakthrough Device Designation for their algorithm to identify patients at risk of decompensated heart failure.
Clinical Applications
Their technology aims to transform heart failure management across all care settings, including ED assessment and triage, inpatient management and discharge, and outpatient and at-home monitoring.
Physician Tip

For physicians, Cardiosense offers a revolutionary approach to heart failure management by providing noninvasive, real-time insights into Pulmonary Capillary Wedge Pressure (PCWP). This allows for earlier detection of worsening conditions, more precise and proactive management of heart failure, and optimization of medication protocols. The CardioTagu2122 device is easy to use and provides rapid, accurate PCWP readings, validated against right heart catheterization. This can lead to timely clinical decision support, reduced heart failure hospitalizations, and improved long-term patient outcomes. The ability to monitor PCWP remotely also facilitates better outpatient and at-home care, detecting and treating worsening conditions before symptoms arise.

CardioSense AI, a related entity or product, mentions seamless integration with existing Electronic Medical Record (EMR) systems for AI-powered ECG interpretation. While specific integrations for Cardiosense's heart failure platform are not explicitly detailed, the focus on providing clinical intelligence and decision support suggests a need for interoperability with healthcare IT systems to maximize utility in various care settings. Data captured by the CardioTagu2122 device can be reviewed in an online dashboard, providing information to doctors previously only available within the hospital setting.

Products by Cardiosense

1 product in the directory

PCWP Analysis
Cardiosense
Cardiology AI
Cardiosense's FDA-cleared AI tool noninvasively estimates pulmonary capillary wedge pressure (PCWP) using a wearable sensor, providing real-time insights for proactive heart failure management.

What the Web Says

Cardiosense is a medical AI company that has developed the CardioTag device, a wearable sensor for noninvasive cardiac function monitoring, and AI-powered software for estimating pulmonary capillary wedge pressure (PCWP). The CardioTag device has received FDA 510(k) clearance, and its PCWP Analysis Software has been granted De Novo classification by the FDA, indicating its novelty and low-to-moderate risk. The company aims to provide clinically actionable insights for early detection of cardiac disease, personalized therapy, and improved patient outcomes, particularly in heart failure management.

Overall: Positive

Strengths

  • Noninvasive cardiac monitoring with the CardioTag device.
  • Simultaneous capture of ECG, PPG, and SCG signals.
  • AI algorithms for estimating cardiac parameters like PCWP.
  • FDA clearance for CardioTag device.
  • FDA De Novo classification for PCWP Analysis Software.
  • Potential for earlier intervention and better management of heart failure.

Limitations

  • Limited public reviews available on platforms like G2, Glassdoor, and Capterra.
  • Reddit discussions primarily focus on other cardiac monitoring devices (e.g., KardiaMobile, CardioMems) rather than Cardiosense specifically.
  • One Reddit post mentions Cardiosense in a list of 'emerging noninvasive technologies' but provides no direct reviews.
  • No specific employer reviews for Cardiosense were found on Glassdoor or Indeed; general cardiology-related company reviews were found instead.
  • The technology is relatively new, with FDA clearances occurring in 2025 and 2026, so long-term user experiences may not yet be widely available.

Based on reviews from: G2, Glassdoor, Capterra, Medical Economics, MedTech Dive, Diagnostic and Interventional Cardiology, Reddit, Cardiosense Company News

Last updated: 2026-10-01

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Press & Coverage

Medical Economics
Cardiosense receives FDA authorization for heart failure monitoring software
Cardiosense received FDA De Novo classification for its PCWP Analysis Software, an AI-based technology that noninvasively estimates pulmonary capillary wedge pressure (PCWP) in heart failure patients. This software works with the CardioTag wearable sensor and aims to enable earlier intervention and better treatment management.
2026-05
Business Wire
Cardiosense Receives FDA De Novo Classification for Novel Cardiac Technology Designed to Improve Care for Patients with Heart Failure
Cardiosense announced FDA De Novo classification for its PCWP Analysis Software, a first-in-class AI-powered technology that noninvasively estimates pulmonary capillary wedge pressure (PCWP) to improve heart failure care. This follows the FDA 510(k) clearance of their CardioTag wearable sensor in July 2025.
2026-05
MedTech Dive
Cardiosense wins FDA clearance for wearable heart monitor - MedTech Dive
The FDA cleared Cardiosense's CardioTag wearable heart monitor, which captures various heart signals like ECG, PPG, and SCG. This device will serve as a foundational component for Cardiosense's noninvasive cardiac AI platform, with plans to integrate it with AI models for cardiovascular parameters.
2025-07
BioSpace
Cardiosense Receives FDA 510(k) Clearance for the CardioTagu2122 Device, Paving the Way for Advanced Cardiac Function Monitoring
Cardiosense announced FDA 510(k) clearance for its CardioTag device, a multimodal wearable sensor that captures high-fidelity ECG, PPG, and SCG signals. This clearance is a significant step towards bringing precision hemodynamic insights into everyday patient care.
2025-07
Fierce Biotech
Cardiosense lands $15M for heart failure-predicting AI - Fierce Biotech
Cardiosense secured $15.1 million in Series A funding, co-led by Broadview Ventures and Hatteras Venture Partners, to advance its AI platform for predicting heart failure. The funding will support clinical studies, product development, and workforce expansion.
2022-12
PR Newswire
Cardiosense, Inc., Completes $15.1 Million Series A Financing to Advance Artificial Intelligence Platform for Heart Disease
Cardiosense, Inc. announced the completion of a $15.1 million Series A financing round, co-led by Broadview Ventures and Hatteras Venture Partners. This capital will be used to expand the team, accelerate product development, and fund a comprehensive heart failure study.
2022-12
PR Newswire
Cardiosense receives FDA Breakthrough Device designation for algorithm to identify patients at risk of decompensated heart failure
Cardiosense, Inc. received FDA Breakthrough Device designation for its algorithm designed to identify patients at risk of decompensated heart failure. This algorithm noninvasively assesses pulmonary capillary wedge pressure (PCWP) using data from the multi-sensor CardioTag device.
2022-02
MentionFox
Cardiosense raised $26.14M — SEC Form D filing, August 2026
Cardiosense, Inc. filed a Form D with the SEC on August 24, 2026, indicating that the company raised $26.14 million in funding.
2026-08

Frequently Asked Questions

Cardiosense offers an AI platform that leverages wearable technology, signal processing, and deep learning to provide clinical intelligence for cardiovascular challenges, primarily focusing on heart failure management. Their flagship product, the CardioTagu2122 device, is a wearable sensor that, in conjunction with their PCWP Analysis Softwareu2122, noninvasively estimates Pulmonary Capillary Wedge Pressure (PCWP) to aid in early detection and proactive management of heart failure.
Cardiosense has received FDA De Novo classification for its PCWP Analysis Softwareu2122, establishing a new regulatory category for AI-based, noninvasive PCWP estimation. Additionally, their CardioTagu2122 wearable sensor received FDA 510(k) clearance in July 2025. The company emphasizes that its technology is built on peer-reviewed research and validated across diverse patient populations.
Cardiosense's revenue structure is based on a combination of direct sales, subscription models, and partnerships with healthcare providers and institutions. Hospitals and clinics typically acquire their CardioTagu2122 Sensors along with access to the Wavesense Platform for an integrated patient monitoring solution. Specific pricing plans are structured to reflect the value of improved patient monitoring and early disease detection capabilities.
Cardiosense provides software solutions designed to integrate seamlessly into existing care environments, aggregating data from CardioTagu2122 and potentially third-party devices into actionable clinical insights. They offer support for product information, research opportunities, and have a contact email for support inquiries. Some sources also indicate 24/7 technical support available for healthcare partners.
Cardiosense's revenue model includes partnerships with healthcare providers and institutions. Their Series A funding round in December 2022 included investments from health system venture funds such as OSF Ventures and UnityPoint Health Ventures, indicating existing relationships within the healthcare ecosystem.
Cardiosense is a Series A company, founded in 2020. They have raised a total of $15.1 million in Series A funding in December 2022, with participation from investors like Broadview Ventures and Hatteras Venture Partners. As of April 2026, the company had 36 employees. Some sources indicate a total funding of $18.0M across two rounds.

Investors

Who's funded Cardiosense.

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