China’s First Lung-related AI Certification! Infervision Becomes the World’s Only AI Medical Company with Access to the Four Major Markets

  • 2020-11-17
The National Medical Products Administration (NMPA) of China officially approved the pulmonary nodule AI Class III certification of Beijing Infervision Technology Co., Ltd. (“Infervision”) on November 13, which is the first lung-related AI Class III certification approved by the NMPA in China. At the beginning of 2020, Infervision became the world’s first company in obtaining the FDA and PMDA certifications for AI in the field of chest and lung CT, and it has so far become the world’s only AI medical company with four major certifications: those from the European Union’s CE, Japan’s PMDA, the United States’ FDA, and China’s NMPA, which means that it has obtained the access to major medical markets in the world.
Making history again! The Class III certification that best demonstrates its technical strength
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. 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 risk level, maturity and publicity of the algorithm it uses, rather than only the process objects, such as the images of cancers, malignant tumors and other diseases. If the diagnostic software automatically recognizes lesion locations through its algorithm and provides clear diagnostic prompts, it will be managed as a Class III medical device due to its relatively high risk.”

Take Infervision’s pulmonary nodule AI product as an example, it belongs to a Class III medical device because it is highly intelligent and can provide powerful auxiliary support for doctors.
Infervision cooperated with many domestic Grade-A tertiary hospitals to conduct a rigorous clinical trial for its pulmonary nodule AI product, which adopted the prospective MRMC (multi-reader multi-case) clinical design in line with international standards and yielded excellent trial results.
Infervision’s pulmonary nodule AI product has extensive indications and can be applied in a wide range of clinical scenarios and asymptomatic or symptomatic patients and also be used by doctors of different seniority. The product has outstanding safety, effectiveness, ease of use, and robustness.
Infervision has put enormous efforts into its pulmonary nodule AI product which can fully meet the needs of doctors and directly participate in the clinical diagnosis process, with clear clinical 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 pulmonary nodule AI product uses deep learning technology for intelligent detection and screening of lung nodules to greatly advance the detection and treatment of lung cancer so that lung cancer patients can receive diagnosis and treatment early and reduce medical expenditures. It has great application value and promotion prospects.

 Certifications for accessing the four major markets
China and the rest of the world, especially the United States, Europe, and Japan, have strict regulation 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.

In such a background, Infervision has outshone others. Since February 2020, 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 lung-related AI Class-III certification from China that best demonstrates its technical strength.

The medical market has increasingly high barriers to entry. The fact that Infervision is the only Chinese AI medical company to receive the certifications for accessing the four major markets is a testament to its strength. Infervision’s AI product is the first lung CT deep learning product approved by the FDA.

Infervision must have made a huge R&D investment for it to meet the requirements for accessing the four major markets at the same time, which is the best proof of the product capability. The four access certifications cover China, the United States, the European Union, and Japan, the four most important markets in the world with the highest medical levels and most stringent access reviews, and provide an important reference for market access in other countries and regions.

Infervision has been the leader in the internationalization of Chinese AI medical enterprises. It established Infervision teams in Japan and North America in 2017, and then Infervision team in Europe in 2018. Its products have been widely praised internationally. More importantly, Infervision is one of the few AI medical companies that have business teams overseas and actually carry out international cooperation. Currently, Infervision cooperates with over 60 medical institutions in many countries and regions with high medical standards in its AI products, such as Switzerland, Germany, the United States, Canada, Japan, France, and Italy.

In the future, Infervision will expand its strategy through a horizontal and vertical layout: vertically, it will have a complete whole-process solution for every related disease; horizontally, it will expand indications for common diseases such as cardiovascular and cerebrovascular diseases, breast cancer, and other high-incidence diseases. With a huge advantage of access to four major markets, Infervision will deepen cooperation with medical institutions around the world to fight diseases that threaten human health and build a community with a shared future for human health.