Recently, the US FDA updated the list of authorized artificial intelligence and machine learning (AI/ML) medical devices. This list is a barometer of the health status of the artificial intelligence industry, and updates show that the FDA is maintaining a rapid pace of authorization. In the past few years, the FDA's AI authorization has maintained double-digit growth, which reflects the increasing number of submissions received by the FDA from AI developers.

AI/ML medical equipment explosion

In the past, the FDA usually updated the list of approved AI/ML devices once a year, but with the frequent changes and approvals of artificial intelligence technology, the FDA has increased the frequency of updating the list. This list update includes 61 new approvals, including products approved between March 31st and June 25th. Similar to previous updates, applications targeting radiology accounted for the majority of the new licenses, with 44 products on the list since the end of March.

According to data compiled by regulatory expert Bradley Merrill Thompson, the number of FDA authorizations has been rapidly increasing since the beginning of the era of medical artificial intelligence around 2016.

Since 2016, the FDA has authorized 950 devices that support AI/ML. Among them, AI applications tailored for radiology account for over 70% of all approved products, totaling 723 types. Following closely behind are 98 applications for the field of cardiology. Neurology ranks third with 34 products. The rest of the product approvals are scattered among other medical specialties.

In recent years, the number of AI/ML medical devices approved by the FDA has grown exponentially. At the beginning of 2023, this number approached 500, and by the end of the same year, nearly 200 more were added to the approved list.

The latest data shows that device authorizations increased by 15% (107 vs. 93) in the first half of 2024 compared to the same period last year, and this rate may grow even faster by the end of 2024- in 2023, the FDA approved 126 devices in the second half of the year, a 35% increase from the first half. At this rate, the FDA should reach over 250 authorizations by 2024, which will be a 14% increase from the 220 authorizations in 2023, and a 14% and 15% increase in 2022 and 2021, respectively.

As with previous updates, radiological equipment accounts for the largest share of AI/ML authorizations, but its share in the first half of the year was 73%, lower than 80% for the entire year of 2023.

Over the years, a total of 22 products have been applied for marketing through the De Novo method, applicable to new medical devices that do not have existing counterparts. This is a special application pathway opened by the US FDA for low-risk innovative medical devices.

Lianying Medical ranks first in China

In terms of brand, after acquiring three companies in the first half of 2024, GE Healthcare took the lead with a total of 80 historical approvals (including its acquired companies such as Caption Health and MIM Software).

Siemens Healthineers followed closely behind and was the brand with the most approvals in the first half of 2024, bringing its total historical approvals to 70 (including Varian).

After GE Healthcare and Siemens Healthineers, Canon Medical has obtained 30 approvals, clinical AI solution provider Aidoc has 24, and Philips has 24.

Subsequently, Lianying Medical from China received 21 approvals, ranking first among domestic brands. From the list, it can be seen that in the past two years, the certification speed of Lianying Medical AI enabled products in the FDA has significantly accelerated, with a total of 7 items in 2023 and 6 items in the first half of 2024.

It is worth noting that the updated list by the FDA includes both pure software algorithms and hardware devices such as scanners with built-in AI capabilities, such as mobile X-ray devices that can alert users to emergency situations. In fact, many authorizations on the FDA list are for updated versions of already approved products, rather than completely new solutions - a trend that often raises the approval share of radiology.

Domestic batch innovation high

The FDA's accelerated update of AI/ML regulatory authorization data is of great significance, as it indicates that with the increasing frequency of AI use in medical devices, the FDA is conducting more transparent and efficient reviews of such products.

In China, with the continuous improvement of regulatory policies, the review and approval of three types of certificates for AI medical devices are also accelerating. Shukun Technology, Shenrui Medical, Tuxiang Medical, and Lianying Medical are leading companies in domestic medical AI.

The "2024 White Paper on the Development of China's Medical and Health Industry" released by the Organizing Committee of the Boao Forum for Asia Global Health Forum, Frost&Sullivan, and the Joint Head Leopard Research Institute shows that from 2019 to 2022, the market size of China's AI medical industry will increase from 12.47 million yuan to 115.56 million yuan, with a compound annual growth rate of 110.1%. It is expected that by 2030, the market will expand to 75568.8 million yuan, with a compound annual growth rate of 39.2%, and the market growth rate will slow down.

And it is pointed out that since 2018, the annual pass rate of China's third class medical device registration certificates has maintained a high-speed growth, and there is no sign of a slowdown in growth rate. As of October 2023, 119 AI medical devices in China have obtained market access and achieved commercialization. In the first ten months of 2023 alone, the number of AI medical devices approved by NMPA has reached 44, setting a new historical high. Among them, AI medical imaging is one of the most widely used scenarios in the medical field.

With the continuous improvement of AI medical device regulation in various countries, it is bound to promote the rapid development of medical AI. In the future, Device Home will also continue to pay attention to the latest developments in this field.

Source: http://qixieke.com/Font/index/detailPage.html?id=3180-135