Deep-learning-based, non-invasive, accurate, and accessible FFR CT test helps physicians diagnose and treat heart disease.

SEATTLE, Wash., January 25, 2023 – Keya Medical announces that its deep-learning-based FFR CT, DEEPVESSEL FFR (DVFFR), is now available for clinical use in the USA. DEEPVESSEL FFR is FDA Cleared, CE Marked, and NMPA Approved.

A recent international multicenter clinical study validated the diagnostic performance of DVFFR on western patient populations, with data collected from ten clinical sites in the US and EU.[1] Joseph Schoepf MD, FACR, FAHA, FNASCI, FSABI, FSCCT, Professor of Radiology, Medicine, and Pediatrics at the Medical University of South Carolina led the clinical trial. “The FDA clearance of DEEPVESSEL FFR is a milestone in Keya Medical’s commitment to developing AI-powered FFR CT technology to improve diagnostic and treatment pathways for patients with cardiovascular disease. As a principal investigator of the ADAPT clinical trial, I am excited to see the implementation of DEEPVESSEL FFR. It comes together with the 2021 ACC/AHA Chest Pain Guidelines recognition of the elevated diagnostic role of CCTA and FFR CT for the non-invasive evaluation of patients with stable or acute chest pain,” said Dr. Schoepf.

One of the leading causes of death in the United States is coronary artery disease.[2] The narrowing or blocking of the coronary arteries can lead to reduced blood flow to the heart resulting in heart attacks and death. DVFFR non-invasive test shows similar accuracy with the “gold standard” invasive procedures for measuring FFR and higher accuracy than other non-invasive tests. The 2021 ACC/AHA Guidelines support the use of Coronary CTA + FFR CT as a front-line pathway.

DEEPVESSEL FFR is a software medical device that uses deep learning technology to perform a non-invasive physiological functional assessment of the coronary arteries using coronary computed tomography angiography (CCTA). The software processes coronary CTA images semi-automatically, generates a three-dimensional model of the coronary artery tree, and estimates FFR CT values. DEEPVESSEL FFR is intended to support the functional evaluation of coronary artery disease. DVFFR analysis may effectively reduce unnecessary invasive coronary angiography procedures and stent implantation for diagnosing and treating coronary artery disease.

About Keya Medical

Keya Medical is an international medical technology company developing deep learning-based medical devices for disease diagnosis and treatment. The company is committed to creating solutions that deliver clinical value at all stages in the patient care process, covering specialties including cardiology, neurology, pulmonology, pathology, and surgery. Keya Medical has four centers of excellence in Beijing, Shanghai, Shenzhen, and Seattle. Follow us on LinkedIn, Twitter, and Facebook.

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[1] Keya Medical, & Medical University of South Carolina. (2022, April 20). Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828590 [2] Centers for Disease Control and Prevention, National Center for Health Statistics. About Multiple Cause of Death, 1999–2020. CDC WONDER Online Database website. Atlanta, GA: Centers for Disease Control and Prevention; 2022. Accessed February 21, 2022.