Earlier this year, Infervision obtained the FDA and PMDA certifications for AI in the field of chest and lung CT, which makes it the world's only AI medical company with four major certifications: those from China's NMPA, the European Union's CE, Japan's PMDA, and the United States' FDA. In addition, Infervision has obtained access to many major medical markets around the world.

China's first lung-related AI 3C certification

Since they are related to people's lives and health, medical products are subject to extremely strict regulatory measures in all countries, and the AI medical industry also has high entry barriers for such devices.

The NMPA has a strict hierarchical management system for medical devices (including medical software) according to the degree of risk. 

The NMPA makes it clear that the risk level of diagnostic software is based on the maturity and publicity of the algorithm it uses, rather than only the targeted disorder, such as cancer, malignant tumors and other diseases. 

If the diagnostic software automatically recognizes lesion locations through its algorithm and provides clear diagnostic prompts, then it will be placed in the third category of medical equipment due to its relatively high risk.

Take the hypothetical pulmonary nodule AI product as an example. Since it is highly intelligent and can provide powerful auxiliary support for doctors, it belongs to the third category of medical devices.

Infervision cooperates with many domestic Grade A class three hospitals to conduct rigorous clinical trials in AI lung nodule products, which adopt the prospective clinical design of reaching MRMC (multireader multicase), benchmarks and international standards, and yield excellent trial results.

The AI products for lung nodules of Infervision can be applied in a wide range of clinical scenarios, involving asymptomatic or symptomatic patients, and can also be used by doctors of different seniority. The safety, effectiveness, ease of use and robustness of the products are all outstanding.

Infervision's AI lung nodule products meet the needs of doctors, and can directly enhance the clinical diagnosis process, with clear application scenarios and high technical thresholds.

The incidence and mortality of lung cancer rank first among malignant tumors both in China and around the world.

Infervision's AI products of lung nodules use deep learning technology for intelligent detection and screening of lung nodules, which greatly advances the detection and treatment of lung cancer, enables early diagnosis and treatment and reduces medical expenditures. 

Four major access certifications leveraging the global AI medical market

Not only China, but also developed countries and regions such as the United States, Europe, and Japan have strict supervision and entry barriers for medical products. This is why there are so many AI medical companies, but only a handful of them can obtain global mainstream market access certification.

Since this February, Infervision has successively obtained CE certification from the European Union, PMDA certification from Japan and FDA certification from the United States, as well as the first Chinese lung-related AI 3C certification. 

In addition, Infervision's AI product is also the first lung CT deep learning product approved by the FDA. The four access certifications not only cover China, the United States, the European Union, and Japan, the four most important markets in the world, but also provide the highest medical level and most stringent access review. They are an important reference for market access in other countries and regions.

Infervision established branches in Japan and North America in 2017, and then established Infervision European teams in 2018. Its products have been widely praised internationally. 

Currently, Infervision has cooperated with over 60 medical institutions in many countries and regions with high medical standards such as Switzerland, Germany, the United States, Canada, Japan, France, and Italy.

An Infervision executive noted that in the future cooperation with medical institutions around the world will be deepened to help build a community of human health with a shared future.