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

Key InvestorsBroadview Ventures, Hatteras Venture Partners, Laerdal Million Lives Fund, OSF Ventures, UnityPoint Health Ventures, Portal Innovations, Alkeon Capital, BoxOne Ventures, Buckley Ventures, Matt Ocko, Daniel Gottlieb, Endeavor Venture Funds, BayMed Venture Partners, GTF Ventures, Oakwood Circle Ventures, Matter
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.
FDA Clearances2 cleared products (estimated)

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 company that leverages wearable technology, signal processing, and deep learning to diagnose and assess cardiovascular diseases, particularly heart failure. Their primary product, the CardioTag device and PCWP Analysis Software, offers a noninvasive method to monitor cardiac function and estimate pulmonary capillary wedge pressure (PCWP), a key indicator for heart failure. The company has received FDA clearance for its CardioTag device and De Novo classification for its PCWP Analysis Software, highlighting its clinical-grade reliability and potential to transform heart failure management.

Overall: Positive

Strengths

  • Noninvasive and accurate monitoring of cardiac function, including PCWP, which traditionally required invasive procedures.
  • FDA authorized and validated against right heart catheterization, with accuracy comparable to implantable sensors.
  • Enables early detection and proactive management of heart failure, potentially reducing hospitalizations.
  • Utilizes multimodal sensing (ECG, PPG, SCG) and AI to provide comprehensive clinical intelligence.
  • Easy-to-use CardioTag sensor deployable at point-of-care, bedside, clinic, or home.
  • Rapid quantitative PCWP readings available in minutes.

Limitations

  • Limited public reviews available on platforms like G2, Glassdoor, Capterra, and Reddit specifically for Cardiosense (the company).
  • Some advanced features of related 'CardioSense - Heart Monitoring' app may require a subscription.
  • The 'CardioSense - Heart Monitoring' app is intended for informational purposes only and not for medical use.
  • General sentiment on Reddit regarding cardiology appointments and doctor responsiveness can be negative, though not directly related to Cardiosense's product.

Based on reviews from: Cardiosense Website, MedGrade, Startup Intros, Fierce Healthcare, MobiHealthNews, Apple App Store, Reddit

Last updated: 2026-07-01

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Press & Coverage

Medical Economics
Cardiosense receives FDA authorization for heart failure monitoring software
Cardiosense announced that the U.S. Food and Drug Administration has granted De Novo classification for its PCWP Analysis Software, an AI-based technology designed to estimate a key measure of heart health in patients with heart failure without the need for invasive procedures.
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 that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Softwareu2122, a first-in-class technology to estimate a key indicator of heart health noninvasively, providing a clear path forward in supporting clinicians who manage heart failure.
2026-05
Diagnostic and Interventional Cardiology
Cardiosense's CardioTag Device Gets FDA 510(k) Clearance for Advanced Cardiac Function Monitoring
Cardiosense announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CardioTag device, a multimodal, wearable sensor that simultaneously captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals.
2025-07
MedTech Dive
Cardiosense wins FDA clearance for wearable heart monitor
The Food and Drug Administration has cleared Cardiosense's CardioTag wearable heart monitor, which captures ECG, PPG, and SCG signals, plus heart and pulse rate, to enable physicians to noninvasively monitor a patient's cardiac function.
2025-07
Business Wire
Cardiosense Appoints Eric Meizlish as CEO to Advance AI-Enabled Cardiac Care
Cardiosense announced the appointment of Eric Meizlish as Chief Executive Officer (CEO), succeeding co-founder Amit Gupta, who will continue as Chief Strategy Officer.
2025-09
Fierce Biotech
Cardiosense pairs advanced sensors with AI for its heart failure wearable
Cardiosense has developed an artificial-intelligence-powered wearable with sensors for electrocardiogram (ECG) data, seismocardiogram (SCG) data, and photoplethysmogram (PPG) data to provide comprehensive cardiac assessment.
2025-08
Knobbe Martens
Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor
Cardiosense received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CardioTag wearable heart monitor, designed to capture various cardiac data for monitoring heart function.
2025-08
The Journal of Innovations in Cardiac Rhythm Management
Cardiosense Receives FDA Breakthrough Device Designation for Algorithm to Identify Patients at Risk of Decompensated Heart Failure
Cardiosense announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify patients at risk of decompensated heart failure by noninvasively assessing pulmonary capillary wedge pressure (PCWP).
2022-02

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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