Cardiosense

What Cardiosense does

Cardiosense, Inc. is a Chicago-based digital health and medical device company founded in 2020 that develops a wearable multi-signal sensor platform and AI-powered software for noninvasive cardiac monitoring, with a primary focus on heart failure management. Its core product, the FDA 510(k)-cleared CardioTag device, simultaneously captures seismocardiographic (SCG), electrocardiographic (ECG), and photoplethysmographic (PPG) signals at the bedside, in clinic, or at home. These signals feed the FDA De Novo–authorized PCWP Analysis Software, an AI-powered Software-as-a-Medical-Device that estimates Pulmonary Capillary Wedge Pressure (PCWP) — historically obtainable only via invasive right heart catheterization — and is positioned as the first and only FDA-authorized noninvasive point-of-care PCWP measurement, validated against right heart catheterization with accuracy on par with implantable sensors.

The platform is supported by nationwide multi-center clinical studies (SEISMIC-HF I and SEISMIC-HF II) and operates under a Quality Management System compliant with 21 CFR 820 and ISO 13485. Cardiosense monetizes through direct enterprise sales of the CardioTag hardware and the PCWP Analysis Software to hospitals, cardiology practices, and heart failure programs in US emergency, inpatient, outpatient, and at-home settings, using quote-based multi-year contracts obtained via a high-touch 'Request a Demo' / 'Start a Conversation' sales motion. The technology originates from research at Georgia Tech (Omer Inan lab) and Northwestern University (Mozziyar Etemadi lab), and the company has raised approximately $30M in venture funding, most notably a $15.1M Series A in December 2022 led by Broadview Ventures and Hatteras Venture Partners. Leadership was substantially refreshed in 2025 with a new CEO (Eric Meizlish) and CMO (John D. Martin) to drive commercial scale-up following FDA clearances.

Name

Cardiosense

Legal name

Cardiosense, Inc.

Website

https://cardiosense.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Cardiosense is a Chicago-based medical device company that has developed the FDA-cleared CardioTag wearable sensor and FDA-authorized PCWP Analysis Software, using AI to noninvasively estimate Pulmonary Capillary Wedge Pressure for heart failure management in US hospitals and outpatient cardiology practices.

Ownership category

akta.pro rank

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

1. CardioTag Device Sales: Sale of the FDA-cleared CardioTag wearable sensor (Class II medical device) to clinicians, hospitals, and health systems for point-of-care cardiac monitoring at the bedside, in clinic, or at home.
2. PCWP Analysis Software Licensing: Sale or licensing of the FDA-authorized PCWP Analysis Software (AI-powered software-as-a-medical device) used to noninvasively estimate PCWP from CardioTag sensor signals; sold/marketed alongside the hardware to clinical customers.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Cardiosense develops and sells two FDA-authorized Class II medical devices: the CardioTag™ wearable multi-signal sensor that simultaneously captures seismocardiographic (SCG), electrocardiographic (ECG), and photoplethysmographic (PPG) signals, and the PCWP Analysis Software™, an AI-powered software-as-a-medical device that noninvasively estimates pulmonary capillary wedge pressure (PCWP) from those signals at the point of care. Together they enable clinicians to monitor heart failure patients in the emergency department, inpatient, outpatient, and at-home settings, providing objective longitudinal hemodynamic trends to guide guideline-directed medical therapy.

Product overview

Cardiosense offers an integrated, platform-plus-modules architecture for noninvasive cardiac monitoring and heart failure management, comprising two FDA-authorized Class II medical devices: (1) the CardioTag™ wearable hardware sensor that simultaneously captures SCG, ECG, and PPG signals at point-of-care, and (2) the PCWP Analysis Software™, a standalone AI-powered software-as-a-medical device (SaMD) that consumes CardioTag signals to noninvasively estimate pulmonary capillary wedge pressure (PCWP). On top of this core pairing, Cardiosense layers AI-enabled clinical modules — including the FDA Breakthrough-Designated PCWP estimator algorithm and the AI-enabled noninvasive volume assessment validated in the SEISMIC-HF studies — that translate raw physiological signals into actionable longitudinal hemodynamic insights for heart failure management across ED, inpatient, outpatient, and at-home settings.

Differentiator

Problem solved

Functional benefit

Brands

• CardioTag: A wearable sensor that captures a patient's seismocardiographic (SCG), electrocardiographic (ECG), and photoplethysmographic (PPG) signals; FDA 510(k) cleared in July 2025.
• PCWP Analysis Software

Products and services

• CardioTag™ Device A wearable, point-of-care cardiac sensor that simultaneously captures seismocardiographic (SCG), electrocardiographic (ECG), and photoplethysmographic (PPG) signals along with heart rate and pulse rate. FDA 510(k)-cleared as a Class II medical device and validated against right heart catheterization with accuracy comparable to implantable sensors. Deployable at the bedside, in clinic, or at home for clinicians, cardiologists, and health systems managing heart failure patients.
• PCWP Analysis Software™ A standalone AI-powered software-as-a-medical device (SaMD) that noninvasively estimates pulmonary capillary wedge pressure (PCWP) from CardioTag-derived SCG, ECG, and PPG signals. FDA De Novo-authorized as a Class II medical device and the first and only heart failure monitoring solution to determine PCWP noninvasively at point-of-care. Provides objective longitudinal hemodynamic trends to clinicians, cardiologists, and outpatient heart failure programs for proactive heart failure management.

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature4 records

Partnerships

Three partnerships are on record, tiered foundational academic partner (spinout origin), strategic research and clinical partner and minor / individual affiliation.

• Georgia Institute of Technology (Georgia Tech)foundational academic partner (spinout origin)Strategic or Co-development PartnerCardiosense is a Georgia Tech spinout whose core technology originated in Omer Inan's research lab. Georgia Tech's commercialization programs (CREATE-X, Biolocity, Georgia Research Alliance) supported the bench-to-patient path; Georgia Tech's commercialization team and Quadrant-i entrepreneurs helped the company navigate FDA regulatory pathways, clinical trials, and capital raising.
• Northwestern Medicine / Northwestern Universitystrategic research and clinical partnerStrategic or Co-development PartnerCo-founder Mozziyar Etemadi serves as Medical Director of Advanced Technologies at Northwestern Medicine and Research Assistant Professor at Northwestern University; Andrew Carek also completed his postdoc in the Etemadi Research Lab at Northwestern. The relationship supports clinical research collaboration and product validation.
• University of Maryland Medical Systemminor / individual affiliationOthersChief Medical Officer John Martin is a Clinical Assistant Professor at the University of Maryland Medical System.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• iRhythm Technologies: iRhythm's Zio long-term cardiac monitoring patch is a leading ambulatory ECG service. While focused on arrhythmia rather than heart failure pressure monitoring, it competes for the same cardiology workflow, clinician relationships, and remote-monitoring reimbursement infrastructure.
• AliveCor: AliveCor's KardiaMobile ECG platform provides consumer and clinician-facing cardiac monitoring with FDA-cleared AI algorithms. It competes with Cardiosense in the AI-enabled cardiac monitoring category and in the cardiology point-of-care workflow, and has a previous executive link (Arezou Azar) to Cardiosense's regulatory leadership.
• HeartFlow: HeartFlow delivers noninvasive AI-based cardiac diagnostics (FFR-CT for coronary disease) using advanced imaging and FDA-cleared algorithms. It is a direct analog in the AI SaMD + reimbursement-driven hospital enterprise sales motion, even though the clinical use case (CAD vs HF) differs.
• Eko Health: Eko Health combines digital stethoscopes with FDA-cleared AI algorithms for cardiac and pulmonary disease detection, including heart failure screening. Its sensor-plus-AI SaMD architecture and cardiology-focused clinical evidence strategy closely parallel Cardiosense's product approach and GTM motion.
• Abbott (CardioMEMS HF System): Abbott's CardioMEMS is the only widely adopted hemodynamic monitoring system for heart failure, using an implantable PA pressure sensor — the closest clinical analog to Cardiosense's noninvasive PCWP solution. It is the primary incumbent competing for the same heart failure hemodynamic monitoring budget and reimbursement codes.

Broad incumbents

• Boston Scientific: Boston Scientific has a growing heart failure franchise (including acquired implantable cardiac contractility modulation and rhythm management devices). It is a strategic competitor that could expand into noninvasive hemodynamic monitoring or compete for the cardiology heart failure budget.
• Philips (Cardiac Monitoring): Philips offers a broad portfolio of inpatient and ambulatory cardiac monitoring, including wearable biosensor solutions used for continuous vital sign monitoring. It competes for hospital cardiology and remote monitoring budgets and brings established sales channels into the same accounts Cardiosense targets.
• Apple (Apple Watch ECG / Health): Apple Watch is the most widely deployed consumer cardiac monitoring device, with FDA-cleared ECG and AFib detection algorithms that screen patients who are then referred into cardiology workflows. It serves as the upstream funnel and indirect competitor to specialist hemodynamic monitoring tools like Cardiosense's PCWP solution.
• Edwards Lifesciences: Edwards Lifesciences is the dominant player in invasive hemodynamic monitoring (Swan-Ganz catheters, pulmonary artery pressure sensors) and is investing heavily in heart failure management. It represents the broad incumbent whose existing hemodynamic franchise could absorb or compete against noninvasive entrants like Cardiosense.
• GE HealthCare (Cardiac Monitoring): GE HealthCare provides inpatient and ambulatory cardiac monitoring solutions as part of a broader patient monitoring portfolio. It competes in the same hospital cardiology workflow for hemodynamic and arrhythmia monitoring budget allocations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cardiosense

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds2 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cardiosense