AccuLine reports 94% sensitivity in clinical trial of its 4-minute cardiac diagnostic system

The study validated the CORA system’s ability to rule out coronary artery disease with a 99% negative predictive value in a noninvasive, clinic-based setting

 The company is initiating a 2,000-patient U.S. clinical trial in collaboration with Mayo Clinic to support regulatory submissions

AccuLine today announced the completion of a clinical trial at seven medical centers in Israel to validate its AI-powered CORA system. The technology is designed to detect coronary artery disease (CAD), a leading cause of death worldwide, by analyzing physiological signals during a four-minute clinical assessment.

The study compared the CORA system’s findings against coronary angiography, the clinical gold standard. In a cohort of 305 subjects, the system achieved 94% sensitivity and a 99% negative predictive value (NPV), effectively allowing clinicians to rule out significant coronary blockages with high confidence and reduce the need for further diagnostic testing. These results indicate the system’s potential as a frontline exam to assess patients with significant CAD while reducing the rate of unnecessary exams for those who do not need them.

According to the World Health Organization, cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for 32% of all deaths. In 2022, CVDs caused an estimated 20 million deaths, 85% of which were due to heart attacks. Despite this, the medical community lacks a diagnostic tool for early detection that is simultaneously accurate, noninvasive and cost-effective.

Current frontline methods often present significant barriers to early diagnosis. Standard exercise stress tests frequently lack the necessary accuracy, while more definitive diagnostic procedures, such as coronary CT angiography or invasive angiography, require the injection of contrast agents, involve exposure to radiation and carry high costs. Furthermore, these tests are typically performed only in hospital settings, often leading to long wait times and under-diagnosis.

“The goal is to provide primary care physicians with an objective diagnostic tool to improve the early detection of CAD,” said Moshe Barel, CEO and co-founder of AccuLine. “The data suggests that this four-minute assessment can effectively risk-stratify patients in a community setting, allowing for more efficient clinical decision-making.”

The CORA system utilizes an AI-powered algorithm that simultaneously analyzes cardiac electrical signals, blood oxygen saturation and respiratory rates alongside the patient’s clinical background. The assessment is noninvasive and does not require the use of contrast agents, exposure to radiation or physical exertion.

AccuLine has raised $5.5 million in funding to date. Investors include eHealth Ventures, Maccabi Healthcare Services and Mayo Clinic, alongside grants from the Israel Innovation Authority and Google. AccuLine and Mayo Clinic have also entered into a know-how agreement for the further development of the CORA technology.

The company is now preparing to launch a large-scale clinical trial at 20 medical centers in the United States involving approximately 2,000 patients. This follows a successful FDA pre-submission completed in December 2025. The trial is part of a comprehensive regulatory roadmap developed in collaboration with U.S. regulatory consultants, with the objective of obtaining FDA 510(k) clearance.

“This large-scale, multicenter study is designed to rigorously evaluate CORA against gold-standard diagnostic modalities for CAD in a real-world clinical setting,” said Timothy D. Henry, MD, Medical Director of the Center for Research and Education at the Christ Hospital Health Network, who will serve as the study’s Principal Investigator. “CORA has the potential to significantly improve front-line decision-making by enabling earlier, non-invasive, and more accessible identification of patients with significant CAD, while reducing reliance on unnecessary invasive procedures.”

Credit: AccuLine