Focus on approval, commercialization How many points should be passed in medical imaging AI?

category:Finance
 Focus on approval, commercialization How many points should be passed in medical imaging AI?


So far this year, only we and Shukun technology have obtained two rounds of financing in the industry. At the meeting, the staff of Keya medical told the reporter of the science and technology innovation board daily. According to relevant data, as of August this year, the financing amount related to the medical imaging AI field totaled 1.56 billion yuan, and the financing amount of Keya Medical Co., Ltd. + Shukun Medical Co., Ltd. was close to 1 / 2 of the total financing amount.

From fanaticism to rationality, what is the future path of medical imaging AI enterprises? How many hurdles to pass?

The first level: is there a card in the approval?

Many reports and analysis in the past believed that medical imaging AI development card was in the approval process, but this situation has changed this year.

On January 15 this year, the State Food and Drug Administration issued the first medical AI class III Certificate in China, and Keya medicals deep pulse score based on deep neural network was employed in clinical application.

This is an important node. With the first node, there is a standard.

For the new generation of AI devices, the regulatory authorities have established a unified consensus to accelerate the development of the new generation of AI technology, and provide a reasonable rule definition for the development and construction of medical artificial intelligence devices, he Weigang, Minister of the medical device review center of the State Drug Administration, said at the second China Medical Imaging AI conference

He Weigang also said: at present, the food and drug administration has established a special medical AI audit team, and released a number of review points on AI medical devices, which have provided help for AI medical devices to be approved as soon as possible.

Therefore, he Weigang believes that the development of medical AI at this stage is not in the process of approval.

According to the information learned by the reporter of science and technology innovation board daily at the scene of medical imaging AI conference with staff of many participating enterprises, for the top enterprises in the industry, class II certificates have already been obtained, and they are rushing for three types of certificates.

The second level: is it difficult to commercialize?

After the approval threshold is stepped down, the commercialization pressure of enterprises will only be greater and greater.

AI is still in the promotion stage, and it is basically used by the top three hospitals, an investor in the medical industry told the reporter of the science and technology innovation board

Liu Shiyuan disclosed at the medical imaging AI conference that at present, the penetration rate of medical AI deployment in tertiary hospitals is 4.5% - 7%, which may reach 15-20% in the future. The epidemic has also played an accelerating role. Liu Shiyuan takes the use of pulmonary nodule products in Changzheng Hospital as an example: the utilization rate of Changzheng Hospital in 2017 is about 60%, and that in 2019 is 70%. After the end of the epidemic this year, the click through rate has reached more than 80%, which is more and more used by doctors.

However, in the larger grass-roots market, Liu Shiyuan also admitted that it was difficult for medical imaging AI products to be implemented because of the poor technical conditions of primary hospitals.

Whats more, how to charge for the products entering the hospital?

On this issue, the aforementioned medical industry investors said: one is that the charging standard is not clear, and there is no medical insurance included.

The reporter of kechuangboard daily tried to understand the current pricing of AI products according to the public information of the hospital. In August 2018, run run run run hospital affiliated to Zhejiang University Medical College issued the notice on announcing the new independent pricing medical service items and prices in 2018, which added (6500 yuan / time for special needs) artificial intelligence assisted multidisciplinary diagnosis and treatment of difficult diseases. However, the proportion of artificial intelligence fees in consultation fees is not clear.

In addition, as mentioned above, there are two AI screening software for sugar net to obtain three types of syndromes. According to relevant media reports, sugar net screening has been included in the list of charges of some hospitals, and sugar net AI enterprises can share it from hospitals. For example, the price of monocular examination in Chongqing is 33 yuan, while that in Guangzhou is 40 yuan. The total number of single eye examinations per day can reach 5000 cases, of which the share proportion of enterprises is about 50%.

It is worth mentioning here that if public hospitals want to charge, they must enter the charging catalogue. Liu Shiyuan revealed at the medical imaging AI conference that some provinces have begun to set up charging catalogue for AI products. However, there is still a long way to go from the establishment to the implementation.

In the insurance sector, as it is difficult to enter the medical insurance system, some commercial insurance companies may join in first in the future. Previously, the reporter of kechuangboard daily learned at the exchange meeting of medi technology that Bohai property insurance will cooperate with Madi technology in the field of assisted reproductive AI.

Third, how should enterprises and hospitals bear legal responsibilities?

A doctors problem will only affect a small number of people, while the problem of medical AI algorithm will endanger a class of people. Dong Jiahong, academician of the Chinese Academy of engineering and President of Beijing Tsinghua Changgeng hospital, directly points out the safety problems faced by medical AI after its landing.

If the imaging doctor based on the wrong medical image AI auxiliary diagnosis report, forms the wrong diagnosis conclusion, the clinician carries on the treatment to the patient according to this. How can enterprises and hospitals bear the legal responsibility for the medical tort damage caused by this?

He Lianhong, a professor and doctoral supervisor of the Law School of Central South University, said in politics and law that according to the causes of AI diagnostic errors in medical imaging, large hospitals, as owners and users of medical imaging detection equipment, may become the subject of liability, and medical imaging software designers, equipment manufacturers, equipment sellers, third parties or other civil owners The body may also become the subject of responsibility. There may be many responsible subjects involved in a diagnosis error. How to identify it? Is there any industry standard? These are the problems that need to be discussed at present. Since the development of medical imaging AI industry, it has experienced the craziest period of capital. The wind has stopped, and the challenges such as approval, commercialization and security issues are constantly on the rise However, it is because of the world is not determined that all the Heroes rise together. At the medical imaging AI conference, reporters from kechuangboard daily found that GPS (GE, Philips and Siemens), the three giants in the medical equipment industry, still occupy the most central position in the exhibition area. In China, there are Lianying, Neusoft medical, Shukun technology, Keya medical, Ender medical, ETO medical, Tui technology and other AI based start-up companies. Source: Science and technology innovation board daily editor: Zhang Mei_ NF2100

There may be many responsible subjects involved in a diagnosis error. How to identify it? Is there any industry standard? These are the problems that need to be discussed at present.

Since the development of medical imaging AI industry, it has experienced the craziest period of capital. The wind has stopped, and the challenges such as approval, commercialization and security issues are constantly on the rise

However, it is because of the world is not determined that all the Heroes rise together. At the medical imaging AI conference, reporters from kechuangboard daily found that GPS (GE, Philips and Siemens), the three giants in the medical equipment industry, still occupy the most central position in the exhibition area. In China, there are Lianying, Neusoft medical, Shukun technology, Keya medical, Ender medical, ETO medical, Tui technology and other AI based start-up companies.