HeartIO

Heart Input Output, Inc., operating as HEARTio, is a digital health company focused on the early and rapid detection of cardiovascular disease. The firm was founded in 2018 by a team of University of Pittsburgh alumni: Adam Butchy, Utkars Jain, and Michael Leasure. The founders' journey is deeply rooted in their academic backgrounds—Butchy and Jain hold PhDs in bioengineering, while Leasure is a graduate of the business school—and personal experiences with the impact of heart disease. Jain, in particular, was motivated by the personal tragedy of his grandfather's death due to a chest pain misdiagnosis, which fueled the mission to provide better diagnostic information to clinicians.

HEARTio operates in the health-tech market, providing a cloud-based software platform for healthcare providers, particularly in emergency room and hospital settings. The company's business model centers on its AI-powered diagnostic tool, ECGio. This platform analyzes a standard 10-second, 12-lead electrocardiogram (ECG)—a ubiquitous and non-invasive test—to detect the presence and severity of coronary artery disease (CAD), specifically the plaque buildup that can lead to heart attacks. The service is delivered via an API hosted on a cloud server; physicians can upload an ECG file and receive a detailed, multi-page report within seconds, a significant reduction from the hours or even days currently required for a deterministic result. This allows medical professionals to more effectively stratify patient risk and make critical admit or discharge decisions at the point of care.

The core of HEARTio's offering is its proprietary machine learning algorithm, which was trained on a massive database of over ten million patient ECG signals. This allows the software to analyze each beat and the comprehensive 12-lead system to identify abnormalities and predict the risk of CAD with high accuracy. A key milestone for the company was receiving a 'Breakthrough Device' designation from the U.S. Food and Drug Administration (FDA) in 2020, a status granted to novel technologies that have the potential to provide more effective treatment or diagnosis for life-threatening diseases. The company has engaged in multiple clinical partnerships, including a large-scale validation study with Allegheny Health Network, to further prove the efficacy and safety of its device as it seeks full FDA approval. HEARTio has secured approximately $1.5 million through a combination of angel investments, foundation grants from entities like the Richard King Mellon Foundation, and numerous competition wins.

Keywords: cardiac diagnostics, ECG analysis software, coronary artery disease detection, artificial intelligence in healthcare, medical imaging AI, health-tech, cardiovascular risk assessment, non-invasive diagnostics, machine learning in medicine, digital health platform, electrocardiogram AI, point-of-care diagnostics, clinical decision support, medical algorithm, Pittsburgh startup, Adam Butchy, Utkars Jain, Michael Leasure, heart attack prevention, plaque buildup detection