Seattle, WA– April 1, 2022– Keya Medical announced that DEEPVESSEL FFR (DVFFR), has been cleared by U.S. Food and Drug Administration (FDA).
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 (CTA) scans. The software processes coronary CTA images semi-automatically, generates a three-dimensional model of the coronary artery tree and estimates CT-derived fractional flow reserve (FFR）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 coronary artery disease diagnosis and treatment.
The key strength of the technology is DVFFR’s innovative deep-learning engine, which not only extracts the 3D coronary artery tree model from the CTA image but also effectively maps out semi-continuous FFR values along the whole reconstructed coronary artery tree within minutes. A recent multicenter pivotal clinical validation study, led by Dr. Joseph Scheopf from the Medical University of South Carolina, had validated the diagnostic performance of DVFFR on western patient populations, with data collected from eight clinical sites (four from EU and four from US).
Keya Medical plans to work with strategic partners to bring this innovative technology to the care of patients with coronary artery disease.
DEEPVESSEL FFR also received China NMPA approval in January 2020 and CE certification in August 2018.
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. Since 2016, Keya Medical has collaborated with more than 725 hospitals to improve diagnostics, care processes, and clinical outcomes. To learn more about Keya Medical, follow us on LinkedIn, Twitter, and Facebook.