Keya Medical's AI-Powered Coronary Fractional Flow Reserve Software Becomes China's First Class III AI Medical Device to Gain Market Approval

VCBeat (WeChat ID: vcbeat) has learned that on January 15, 2020, a product developed by a subsidiary of Keya Medical received approval from the Center for Medical Device Evaluation. According to Keya Medical, this marks the first Class III medical device incorporating artificial intelligence technology to be approved in China. The following is the content of the announcement issued by the National Medical Products Administration:

This product is based on coronary CT angiography images and consists of an installation disc and a dongle. Its functional modules include basic image operations, based onDeep Learning Technologyvascular segmentation and reconstruction, vascular centerline extraction, based onDeep Learning Technologycalculation of fractional flow reserve. One invention patent has been granted, and two invention patents are under substantive examination.

This product employs non-invasive technology to reduce unnecessary coronary angiography examinations and avoid unwarranted interventional procedures, thereby lowering costs, alleviating patient suffering, and enabling early diagnosis, with significant economic and social benefits. No similar products are currently registered and marketed in China, while only one comparable product is available in the United States internationally. Compared with similar domestic and international products, this product’s performance indicators are at an internationally leading level.

The drug regulatory authorities will strengthen post-market supervision of this product to ensure the safety of patients using medical devices.

DeepVessel Score® leverages its proprietary DeepVessel and DeepFFR deep learning algorithms, which are based on hemodynamics and deep neural networks, to perform non-invasive functional analysis (CT-FFR) using coronary computed tomography angiography (CTA) images. By integrating artificial intelligence technology into the clinical diagnosis and treatment workflow for coronary heart disease (CHD), it effectively enhances the diagnostic and therapeutic capabilities of medical institutions in China. This achievement represents a genuine technological innovation in the healthcare sector, aligning with China’s national AI development strategy and overall planning, while also serving as an exemplary model for the application of AI technologies in precision medicine.

Keya Medical was founded in 2016.Initially, it has completed financing amounting to hundreds of millions of yuan, with the Series A round led by Alwin Capital. Its independently developed non-invasive CT-FFR DeepPulse Fraction product is the first to enter the nationalNMPA’s “Green Channel for Innovative Medical Devices”: Three Class III AI Medical Imaging Products。

In China, Keya Medical has established in-depth collaborations with more than 200 hospitals, developing a series of vascular function assessment products centered on the circulatory system and an intelligent imaging platform serving radiology departments.

Keya Medical has also successfully entered the international market. Its DeepVessel FFR product obtained European CE certification in August 2018 and is currently offering paid services in Hong Kong, Malaysia, and other regions. The company’s intelligent imaging platform has integrated with multiple major medical centers and radiologist groups in the United States, while also establishing commercial partnerships with several medical device manufacturers, thereby achieving successful product implementation.