Medical equipment AI + "waves hit, China's AI medical equipment quality evaluation quickly promoted
Source: China Pharmaceutical News
For AI medical devices, the past 2018 is a year worth remembering. FDA approved for the first time several medical devices that claim to use artificial intelligence, including independent software, system components, etc., to promote the "medical device AI +" wave in the fields of ophthalmology, orthopedics, and gastroenterology. It has also inspired the enthusiasm of the countries of the world. At the same time, China's AI medical devices are in full swing, and the number of enterprises is growing. The intended use and functions of the products are changing with each passing day. They have achieved outstanding results in various competitions held at home and abroad. Collective presentations at RSNA and other occasions have attracted widespread attention at home and abroad.
However, due to the rapid iteration of the algorithm and the lag of the standard specification, the research on product quality evaluation of AI medical devices still faces many challenges. As a large number of products emerged and entered the inspection stage, in order to better serve the enterprise and support the technical review, under the deployment of the national drug regulatory authorities, China Institute of Food and Drug Verification(hereinafter referred to as the Central Inspection Institute) focused on the quality evaluation of AI medical devices. From the perspectives of theoretical strategy, inspection practice, and standardization, the quality evaluation of AI medical devices is progressing smoothly.
Reprint: medworld Medical World