Infervision Secures First-Ever UKCA Certification for AI-Powered Tuberculosis Screening, Achieving Regulatory Approvals Across Five Major Global Markets

Recently, the British Standards Institution (BSI) officially granted Infervision UKCA certification for its tuberculosis AI solution, marking the first such certification awarded to a Chinese AI healthcare company. As of July 2023, Infervision is the first and only Chinese AI medical technology company whose products have received regulatory approvals in five major markets: China, the United States, the European Union, the United Kingdom, and Japan. Having secured market access in most of the world’s key healthcare regions, its products are now deployed in more than 1,000 medical institutions across over 20 countries worldwide.

Less than two weeks ago, Infervision’s AI-assisted screening product for chest diseases based on digital radiography (DR) officially obtained MDR CE certification. To date, this marks the first MDR CE certification granted globally to a Chinese AI healthcare company specifically for tuberculosis screening and diagnosis. Coupled with the UKCA certification recently awarded to Infervision’s AI-based tuberculosis product, the company’s tuberculosis AI solution has now secured dual certifications: EU MDR CE and UK UKCA.

As medical products are directly related to human life and health, they are subject to extremely stringent regulatory measures worldwide. Consequently, the AI healthcare industry also features high barriers to entry. The UKCA (UK Conformity Assessment) mark is a product certification scheme introduced by the UK government to ensure that products sold in the UK market comply with relevant technical standards and requirements. Owing to its highly developed healthcare system, innovative R&D environment, international cooperation and exports, as well as strong government support and regulation, the United Kingdom is regarded as one of the major global markets for medical devices. This makes the UK an important destination for domestic and foreign medical device manufacturers and suppliers, securing its significant position in the global medical device market.

▲ Conceptual Image of Infervision’s DR Product

Since 2021, the United Kingdom has formally completed its Brexit process and withdrawn from the European Single Market and the Customs Union. Consequently, products intended for sale in the UK market must comply with new market access requirements, making UKCA certification a mandatory prerequisite for lawful commercialization. TuiXiang has taken the lead by securing UKCA certification for its tuberculosis-related products, thereby gaining a first-mover advantage in the UK market and laying a solid foundation for subsequent commercialization efforts.

Beyond securing UKCA certification for the UK market, Infervision has previously been successfully included in the National Health Service’s commercial services catalog and has established offices in both London and Birmingham, further deepening its presence in overseas markets such as the UK.

As early as 2021, InferRead CT Lung, independently developed by Infervision, was included in the UK National Health Service Shared Business Services (NHS SBS) framework, providing early screening services for pulmonary nodules to patients in the UK and helping the NHS reduce the costs of lung cancer prevention and treatment. In May 2023, Infervision’s AI solutions were once again selected for the NHS SBS framework. The consecutive renewals through the NHS SBS framework hold profound significance for Infervision, as they not only signify recognition and endorsement by the UK’s national healthcare system but also demonstrate that our service and deployment capabilities have withstood the test of the international market.

Infervision’s AI-assisted diagnostic products have successively obtained medical device registration certificates from the European Union (CE), the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), China’s National Medical Products Administration (NMPA), and the United Kingdom (UKCA) since 2020. This achievement makes Infervision the first—and currently the only—Chinese AI healthcare technology company whose products have secured regulatory approvals from these five major medical markets and authoritative bodies, officially ushering in the era of “full certification across five key markets” and unlocking the global AI healthcare market. This milestone is underpinned by substantial R&D investment and serves as the strongest testament to the capabilities of Infervision’s products. Covering the world’s most significant, advanced, and stringently regulated healthcare markets, Infervision’s “five certifications” also provide a critical reference for market access in other countries and regions worldwide.

▲ Infervision AI Goes Global: Overseas Doctors Praise Chinese Enterprises

Infervision has consistently remained at the forefront of Chinese AI healthcare companies in their internationalization efforts. Since 2018, Infervision has successively established teams in Japan, North America, and Europe, earning widespread acclaim for its products globally. More importantly, Infervision is one of the few AI healthcare enterprises that maintains overseas business teams and actively engages in genuine international cooperation, continuously achieving new progress and positive developments in product registration, overseas commercialization, and the formulation of international standards.

As an international AI-driven medical innovation enterprise, Infervision has always taken it as its mission to build a community of common health for mankind. Adhering to a “one-horizontal, one-vertical” product strategy, the company implements end-to-end management from single-disease imaging to clinical practice along the “vertical” axis, while continuously exploring cutting-edge AI technologies across multiple major disease areas along the “horizontal” axis. Leveraging significant advantages in market access across five major regions, Infervision will continue to deepen collaboration with healthcare institutions worldwide, combat diseases that threaten human health, and contribute to building a community of common health for mankind.