The Chinese Artificial Intelligence Education and Research Alliance hosted the 2nd Congress of China Artificial Intelligence in Medical Imaging conference on Sept. 18-20 in Shanghai International Convention Center. The conference brought together experts in medical imaging AI from across the country.

As the first medical imaging AI company in China to receive regulatory approval from the National Medical Products Administration (NMPA), Keya Medical was invited to attend the conference. On behalf of Keya Medical, Dr. Kunlin Cao, President of Keya Medical R&D, delivered a keynote speech on Keya Medical’s experience bringing AI-powered medical imaging solutions to clinical use.

NMPA Regulatory Policy for Medical AI Software

Dr. Cao’s keynote address presented in the Approval and Landing Development Forum detailed how Keya Medical has managed to ride the waves in the medical imaging AI to come out ahead of its competitors. Since the first conference took place nearly two years ago, the medical AI industry has experienced ups and downs as the community has worked to make progress and bring valuable solutions to clinical use.
Dr. Cao shared that medical imaging AI is currently undergoing the test of commercial landing. If medical AI products are to be successfully commercialized and used in clinical settings, products need to be efficiently developed and receive support from the industry, in addition to obtaining regulatory approval.

In China, medical imaging AI products need to obtain a Class III medical device license approved and registered by the National Medical Products Administration (NMPA) before they can be sold. Keya Medical has always emphasized the importance of ensuring that products are developed in compliance with regulatory guidelines from the early stages of product development. Through an in-depth exploration of the current pain points experienced in the industry, Keya Medical’s R&D team has been able to successfully develop products that improve the diagnosis of cardiovascular diseases.

Innovation and Compliance

Keya Medical’s non-invasive CT-FFR product, DEEPVESSEL FFR, received regulatory approval from the NMPA on Jan. 15. Dr. Cao explained that DEEPVESSEL FFR uses deep learning algorithms to perform a non-invasive physiological functional assessment of the coronary arteries using coronary CT angiogram scans. The product has been implemented in nearly 100 health systems in more than 20 provinces in China.

The success of Keya Medical can be attributed not only to the company’s emphasis on technological innovation but also to the R&D team’s accumulation of industry knowledge and experience over the past ten years. Before working for Keya Medical, scientists gained industry experience at leading medical technology manufacturers around the world, including GE and Qualcomm. The R&D team combines their expertise with a commitment to understanding clinicians’ needs to develop solutions that are compliant with regulatory standards.
To develop compliant solutions, Keya Medical has established a quality system that meets the requirements of deep learning software in accordance with the Key Points for Deep Learning-aided Decision-making Medical Device Software Review issued by the NMPA.
In terms of product certification, Dr. Cao acknowledged that Keya Medical did not have similar products to use as a reference in the process of obtaining product approval and certification and encountered several obstacles during the regulatory approval process. The team continuously communicated with the NMPA to gain guidance and support from the regulatory body, accumulating valuable insight into developing compliant solutions.
Keya Medical’s ability to successfully bring DEEPVESSEL FFR to clinical use has been guided by the company’s commitment to both product innovation and compliance. Moving forward, Keya Medical will continue to uphold these principles to develop products like DEEPVESSEL FFR that demonstrate excellent quality and bring benefits to both physicians and patients.