על החברה
AccuLine is a medical device company developing CORA, an AI-powered cardiac diagnostic platform for the point of care. In a four-minute, non-invasive exam, CORA combines ECG, SpO2, respiration, and clinical data, analyzes them in the cloud, and delivers a clear report to the treating physician. The first indication is coronary artery disease, the leading cause of death worldwide and one of the hardest conditions to detect early in a primary care setting. Today, most patients are either referred late to costly and invasive testing or missed entirely. CORA is designed to close that gap by giving primary care physicians a fast, accurate, and affordable way to identify cardiac disease at the first point of contact.
Our pilot study of 305 patients across 7 sites showed 94% sensitivity and 99% negative predictive value against invasive angiography. We are now running a US-based pivotal study across leading centers, including Mayo Clinic and The Christ Hospital, on the path to FDA 510(k) clearance. Our core technology is protected by a US patent with all 31 claims allowed, with applications pending in the US, EU, and Japan. On the reimbursement side, a dedicated CPT Category III code takes effect in January 2027, and CMS has proposed a new payment framework for software-based medical services, both of which support our future commercial model.
AccuLine was founded in 2022 by a team combining deep expertise in cardiology, signal processing, machine learning, and medical device commercialization. We are backed by eHealth Ventures, Maccabi Healthcare, and Mayo Clinic, and supported by grants from the Israel Innovation Authority and Google. The company is headquartered in Petah Tikva, Israel, with a US parent entity and a growing US clinical and business presence.
Beyond coronary artery disease, the same platform is being extended to additional indications, including microvascular dysfunction, heart failure, aortic stenosis, and pulmonary hypertension, positioning CORA as a multi-indication cardiac diagnostic platform rather than a single-purpose device.
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