On December 27, 2023, Keya Medical’s CT FFR product DEEPVESSEL FFR (DVFFR) passed the certification of the Health Sciences Authority (HSA) of Singapore and was officially launched in Singapore! This is a breakthrough for Keya Medical’s artificial intelligence medical software and an important step on the road to international implementation of DEEPVESSEL FFR.
As the regulatory agency for drugs and medical devices in Singapore, the Health Sciences Authority (HSA) of Singapore has strict certification standards for product safety, effectiveness, and quality. DVFFR has been certified by the Singapore HSA, which means that the product meets strict safety standards and can be legally sold and used in the Singapore market. It also fully demonstrates its advantages in technical strength, safety, and effectiveness. The Singapore HSA certification not only indicates DVFFR’s application worldwide but also a wider access of patients to efficient and accurate CT-FFR services.
DEEPVESSEL FFR is the world’s first CT-FFR product that has obtained four certifications – China’s NMPA, EU CE, US FDA, and Singapore HSA. DVFFR was developed by Keya Medical, a leading international AI medical technology company. It is based on deep learning technology to evaluate the physiological function of coronary arteries. It uses coronary CT angiography (CCTA) images to perform AI coronary CT fractional flow reserve measurement (i.e. AI CT-FFR), which can quickly and accurately evaluate whether coronary stenosis leads to myocardial ischemia.
DVFFR combines the technical advantages of CCTA and FFR and realizes the technical innovation of non-invasive calculation of coronary physiological function information from medical imaging data. Only the CCTA imaging data of the tester is required to quickly and accurately calculate the CT-FFR value of each point on the entire coronary vascular tree. The accurate, fast, and safe quantitative analysis of the coronary blood supply assists clinical providers in selecting the diagnosis and treatment path for coronary heart disease. Looking to the future, Keya Medical will adhere to the concept of “technology empowers medical care, innovation serves health” and promote more high-quality artificial intelligence products worldwide.
About DEEPVESSEL FFR
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 CT FFR values. DEEPVESSEL FFR is FDA-Cleared, CE-Marked, NMPA-Cleared, HSA-Certified.
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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