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Routine 12-lead ECG in Investigational · not FDA cleared

AI designed to find heart disease in a routine ECG

HEARTio is developing software intended to identify coronary artery disease from the 10-second ECG clinics already record, so that disease can be found earlier. It is an investigational device and is not yet available for clinical use.

No new hardwareDesigned for any standard ECG machine
Non-invasiveNo contrast, no radiation
10 secondsOne resting ECG recording
The problem

Heart attacks happen every minute.
Most are preventable.

Events like heart attacks are linked to the gradual build-up of plaque in the arteries of the heart. The narrowing is silent for years, and today it is usually found only after a patient has symptoms, or after the attack itself.

Finding blockage early means an invasive catheterization, a CT with contrast, or a nuclear perfusion scan. Each needs a referral, a specialist and a machine the patient has to travel to.

SilentPlaque builds for years with no symptoms
InvasiveToday's tests need contrast, radiation or a catheter
Too lateFor many patients the first sign of coronary disease is the heart attack itself

What if coronary disease could be found earlier with:

  • No new hardware
  • No surgery
  • Just 10 seconds
  • No contrast or radiation

That's what HEARTio is being built for. Software designed to flag coronary blockage before it causes a heart attack.

Our solution

AI software under development to read a routine ECG for coronary disease

HEARTio is intended to help providers find coronary artery disease earlier. The input is the same 10-second resting ECG that clinics, emergency departments and wearables already capture. The software is investigational and has not been cleared or approved by the FDA.

Routine ECGAny lead set, any machine
+
HEARTio AIDeveloped on ECGs paired with angiography and PET reference data
=
Estimate of coronary blockageWhich vessel, how severe, and its estimated effect on the heart
One validation ECG open on three surfaces at once: the PDF report page, the browser console and the iPhone app, each drawing the same coronary tree and the same four estimates — LM, LAD, LCx, RCA — at the same percentages and in the same colours.

What the software is designed to offer

No contrast or radiationNothing is injected and nothing is imaged.
Results with the ECGEstimates are returned in seconds, alongside the recording.
Runs anywhereCPU inference, so it fits a clinic, a cart, or the cloud.
Built with cliniciansDeveloped and evaluated against angiography and PET-CT reference data with our clinical partners. Clinical validation is ongoing.
Team

Engineers, cardiologists and operators, together

A founding team out of the University of Pittsburgh and the Wharton School, backed by advisors across interventional and nuclear cardiology, emergency medicine, regulatory affairs and capital markets.

HEARTio Executive Team

Email any of us to learn more.

Utkars Jain, PhD
Utkars Jain, PhDCo-Founder & CEO
John Marous
John MarousExecutive Chairman
Adam A. Butchy, PhD
Adam A. Butchy, PhDCo-Founder & CSO
Michael Leasure
Michael LeasureCo-Founder & COO
John Moran
John MoranCo-CCO
Jake Fisher
Jake FisherCo-CCO

Clinical Advisory

Interventional, nuclear and structural cardiology, cardiothoracic surgery, critical care and emergency medicine.

Gary S. Mintz, MD
Gary S. Mintz, MDActing Medical DirectorInterventional Cardiology, Cardiovascular Research Foundation
Veronica Covalesky, MD
Veronica Covalesky, MDActing Medical DirectorNuclear Cardiology, Cardiology Consultants of Philadelphia
Sourbha Dani, MD
Sourbha Dani, MDClinical AdvisoryNon-Invasive Cardiology, Lahey Clinic
Joshua Brown, DO
Joshua Brown, DOClinical AdvisoryEmergency Medicine, Main Line Health
Sarah Minasyan, MBA, MD
Sarah Minasyan, MBA, MDClinical AdvisoryCardiothoracic Surgery, UC Davis Health
Rajan Kadakia, MD
Rajan Kadakia, MDClinical AdvisoryInterventional Cardiology, Houston private practice
Saif Anwaruddin, MD
Saif Anwaruddin, MDClinical AdvisoryStructural Heart Cardiologist, Jefferson University Hospital
Michael Nelson, MD
Michael Nelson, MDClinical AdvisoryBoard-certified in six cardiac and vascular specialties
George Magovern, MD
George Magovern, MDClinical AdvisoryCVI Chief Academic Officer, Allegheny Health Network
Dheeraj Duggineni, MD
Dheeraj Duggineni, MDClinical AdvisoryEmergency Medicine, Interim Assistant Medical Director, Stanford
Rosy Thachil, MBA, MD
Rosy Thachil, MBA, MDClinical AdvisoryDirector, Cardiac Intensive Care Unit, Elmhurst Hospital Center
John Jefferies, MD, MPH, MBA
John Jefferies, MD, MPH, MBAClinical AdvisoryPediatric and Adult Cardiology

Product Development Board

ECG interpretation, medical AI and clinical strategy.

Philip Podrid, MD
Philip Podrid, MDSenior Scientific Advisor (ECG Analysis)Product Development Board
Arturo Loaiza-Bonilla, MD
Arturo Loaiza-Bonilla, MDProduct Development BoardCo-Founder / CMAIO at Massive Bio; Systemwide Chief of Hematology and Oncology at St. Luke's
Prahlad Menon, PhD
Prahlad Menon, PhDAI & Strategy AdvisorProduct Development Board; Medical AI Professor at Pitt / CMU

Business & Strategy

Medtech operators, product leaders and global strategy.

Mike Rice
Mike RiceStrategy AdvisorFormer CEO, BioLife; Medtech board member
Edmund Shaw
Edmund ShawStrategy AdvisorFormer Sr. Global Product Manager, sleep diagnostics, Philips
Nathan Qin
Nathan QinBusiness AdvisorFounder & Managing Partner, qinnovativ medtech GmbH
Varun Verma
Varun VermaStrategy AdvisorCardiopulmonary medical device product management
Zeke Hernandez, PhD
Zeke Hernandez, PhDGlobal Strategy AdvisorMax and Bernice Garchik Family Presidential Professor, The Wharton School
Rachel Croft
Rachel CroftStrategy & CEO AdvisorMedTech / digital health marketing and strategy

Regulatory & Reimbursement

FDA, quality systems, biostatistics and reimbursement.

Steve Brooks, MD
Steve Brooks, MDFDA ConsultantPrincipal, Brooks Medtech LLC; former Medical Officer, FDA
Austin Griggs
Austin GriggsRegulatory and Quality AdvisorVP of Global Regulatory Affairs and Quality Assurance, Align Technology
Larry Yost
Larry YostReimbursement ConsultantManaging Partner, The Atticus Group, LLC
Colleen Kelly, PhD
Colleen Kelly, PhDFDA Stats ConsultantPresident, Kelly Statistical Consulting

Capital Raising & Financial

George Kenney
George KenneyChief Capital OfficerShepherd Ventures III
Robert Kramarz
Robert KramarzChief Capital OfficerShepherd Ventures III
Chris O'Brian
Chris O'BrianFinancial & Transaction AdvisorChris O'Brian Consulting
Partners

Investors, clinical partners and programs behind HEARTio

The health systems that share the data, the funds that back the company, and the accelerators that shaped it.

Investors

Shepherd Ventures
Allegheny Health NetworkAudacious CapitalVU Venture PartnersTransform Health VenturesTK PartnersIntelligence VenturesBessel
ACC Cardiovascular Innovation Ventures
Richard King Mellon FoundationInnovation WorksUniversity of PittsburghLifeX

Clinical Partners

Allegheny Health NetworkCardiology Consultants of PhiladelphiaMedStar Health

Incubators & Accelerators

Creative Destruction Lab
NVIDIA Inception Program
Microsoft for Startups
HeartX
Olympus

Awards & Honors

Forbes 30 Under 30
2024 Lister
Pittsburgh Business Times 30 Under 30
2022 Lister
PDMA
Innovator of the Year
ISMICS
Innovators of the Year
LIFTOFF PGH
First Place
Baylor New Venture Competition
First Place
Tulane Business Model Competition
First Place
University of Pittsburgh
Innovators of the Year
News

Recent news

All updates on LinkedIn ↗

Watch

Talks and pitches from the team. Each recording reflects the date it was given.

Publications

Peer-reviewed work behind the platform

Selected HEARTio publications, from lead reconstruction to angiography- and PET-verified disease prediction.

  • 2026JACC Advances
    Use of Electrocardiograms to Identify Coronary Artery Disease
    Leasure M, Poornima I, Butchy A, et al. JACC: Advances. 2026;5(3):102573.
    doi:10.1016/j.jacadv.2025.102573
    View paper
  • 2025JACC · TCT
    TCT-898 A PET-CT verified AI Algorithm to predict the ischemic impact of Coronary Artery Disease
    Leasure M, Mintz G, Covalesky V, Jain U, Butchy A. JACC. 2025;86(17):B386-B387.
    doi:10.1016/j.jacc.2025.09.1081
    View paper
  • 2024medRxiv
    Artificial Intelligence Analysis of ECG to Determine Fractional Flow Reserve (FFR)
    Kalińczuk Ł, Zieliński K, Sadowski KA, et al. Published online August 28, 2024.
    doi:10.1101/2024.08.27.24312672
    View paper
  • 2023IEEE BIBM
    Classification of Abnormal Cardiac Rhythm from Brief Single-Lead ECG Recordings using Embeddings from Transformer Encoder Models
    Jain U, Menon PG. 2023 IEEE International Conference on Bioinformatics and Biomedicine (BIBM). 2023:4899-4901.
    doi:10.1109/bibm58861.2023.10385454
    View paper
  • 2023Circulation
    Abstract 18317: Implications of Noise on Deep Learning Models for 12-Lead ECG Construction
    Jain U, Leasure M, Butchy A, Covalesky VA, Mintz GS. Circulation. 2023;148(Suppl_1).
    doi:10.1161/circ.148.suppl_1.18317
    View paper
  • 2023BIOSTEC
    Redundancy and Novelty Between ECG Leads Based on Linear Correlation
    Jain U, Butchy A, Leasure M, Covalesky V, McCormick D, Mintz G. Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies. 2023:359-365.
    doi:10.5220/0011815700003414
    View paper
  • 2022BIOSIGNALS
    12-Lead ECG Reconstruction via Combinatoric Inclusion of Fewer Standard ECG Leads with Implications for Lead Information and Significance
    Jain U, Butchy A, Leasure M, Covalesky V, McCormick D, Mintz G. BIOSIGNALS. Published online 2022.
    doi:10.5220/0010788600003123
    View paper
  • 2021Circulation
    Abstract 13330: Deep Learning Algorithm Predicts Angiographic Diameter Stenosis in Stable Patients Using Only a Standard 12-lead Electrocardiogram
    Leasure M, Jain U, Covalesky VA, McCormick DJ, Mintz GS. Circulation. 2021;144(Suppl_1).
    doi:10.1161/circ.144.suppl_1.13330
    View paper
  • 2021JACC · TCT
    TCT-60 Deep-Learning Algorithm Predicts Presence of Angiographic Coronary Artery Disease in Stable Patients Using Only a Standard 12-Lead Electrocardiogram
    Jain U, Leasure M, Butchy A, Covalesky V, McCormick D, Mintz G. Journal of the American College of Cardiology. 2021;78(19):B24-B25.
    doi:10.1016/j.jacc.2021.09.910
    View paper
  • 2021Can J Cardiol
    Deep Learning Algorithm Predicts Angiographic Coronary Artery Disease in Stable Patients Using Only a Standard 12-Lead Electrocardiogram
    Leasure M, Jain U, Butchy A, et al. Canadian Journal of Cardiology. 2021;37(11):1715-1724.
    doi:10.1016/j.cjca.2021.08.005
    View paper
Research console

See the research console

The ECGio Analysis Console is available to partners and investors for research and demonstration purposes only. Drop in an ECG file, or pick a sample record, and see the model's estimates. It is not for clinical use and must not inform patient care.

ECGio Analysis Console

Upload a resting ECG in the format your machine exports. The console reads it and returns thirty-six outputs — coronary, perfusion, structural, infarct, function and the 12-lead reconstruction — each beside the recorded validation of the head that produced it, and a downloadable seven-page summary.

CSVTXTH5GE MUSE XMLPhilips XMLHL7 aECGDICOMPDFMATEDFNPYApple WatchJSONJPEGPNGHEIC
Open demo.heartio.ai ↗

Sign-in required. Request access. Research use only.

  • Any ECG, any format12-lead or fewer, any sampling rate. Even a single-lead watch strip is handled, with the caveat shown.
  • Or a photo of the paperNo digital export? Photograph or scan the print-out. Each trace is read off the grid and digitised, and the leads it recovered are shown for review before anything is analysed.
  • See the ECG the model readThe recording is shown lead by lead beside the estimates, so nothing is a black box to the reviewer.
  • Coronary tree and flow mapPer-vessel stenosis on an angiographer's coronary tree, and predicted flow reserve across the four myocardial territories.
  • Report and JSON exportA PDF summary for review and a structured document for research integration.