AI medical class III certificate is finally out!Keya Medical’s “Coronary Flow Reserve Fractional Calculation Software” was approved for listing

AI medical class III certificate is finally out!Keya Medical’s “Coronary Flow Reserve Fractional Calculation Software” was approved for listing

Recently, the State Drug Administration approved the registration of the innovative product “Coronary Blood Flow Reserve Calculation Software” produced by Beijing Kunlun Medical Cloud Technology Co., Ltd. This is the first three types of documents named after “deep learning”.

The product is based on coronary CT angiography, and consists of an installation CD and a dongle. The functional modules include basic image operations, blood vessel segmentation and reconstruction based on deep learning technology, blood vessel centerline extraction, and deep learning technology-based blood flow reserve fraction calculation. 1 invention patent has been obtained, and 2 invention patents are in the substantive examination stage.

The product adopts non-invasive technology, which can reduce unnecessary coronary angiography, avoid unnecessary interventional operations, reduce costs, relieve pain of patients, and can be used for early diagnosis, with significant economic and social benefits. There is no product of the same variety registered and listed in China, and only one product of the same variety has been listed in the United States. Compared with the same varieties of products at home and abroad, the performance indicators of this product are at the international leading level.

The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients using the device.

Keya Medical was established in 2016. Its self-developed non-invasive CT-FFR deep pulse fraction product is a three-category artificial intelligence medical imaging product of NMPA’s “Green Channel for Innovative Medical Devices”.

Different from the traditional detection method based on flow field simulation, DEEPVESSEL FFR of Keya Medical adopts the self-developed feature flow deep learning technology based on hemodynamics, which can quickly and accurately calculate the path of the entire vascular tree. The FFR value of the point can be used to provide the quantitative detection results required by the clinic, so as to achieve accurate and real-time analysis, and achieve the purpose of reducing the cost of diagnosis.

In fact, Shenmai Score has obtained the European CE certification in August 2018, and has now started charging services in Hong Kong, Malaysia, etc.

In China, Keya Medical has cooperated deeply with more than 200 hospitals to develop a series of vascular function assessment products around the circulatory system and an intelligent imaging platform serving the imaging department.

In addition, the announcement mentioned that there is currently no domestic product of the same variety registered and listed, and only one product of the same variety has been listed internationally in the United States. This product is from HeartFlow, a California company founded by Stanford University scientists Charles Taylor and Chris Zarins in 2007.

Lei learned that HeartFlow’s core product is cardiovascular hemodynamic simulation auxiliary diagnosis software, which can use AI technology to help visualize the heart, form a personalized, color-coded 3D model of the patient’s coronary artery, and assist in the diagnosis of coronary heart disease.

HeartFlow’s similar products obtained European CE certification in 2011 and US FDA approval in 2014.

Keya Medical’s AI products have been approved. However, it is worth noting that the sugar net and coronary products of three companies including Eagle Eye Medical, Shukun Technology, and Silicon Intelligence also entered the NMPA “Green Channel for Innovative Medical Devices” last year. 2020, or the year when medical AI companies make a name for themselves.

The Links:   ACS150-03E-02A4-4 / 68581753 3BSE040662R1 DISPLAY

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