Infervision Secures CE Certification, Launching Global Commercialization from Europe with InferRead AI Platform
It seemed that overnight, China was engulfed by the tension triggered by the COVID-19 pandemic. Infervision’s domestic team responded swiftly, urgently developing AI products targeted at COVID-19. By late January, these solutions were deployed and put into use in multiple hospitals in Wuhan, the epicenter of the outbreak, with nearly all resources dedicated to the front lines of the epidemic response.
At this very moment, Mr. Sun Yipeng, Head of Infervision’s European Division, remained in Europe. He had long since decided to forgo the Spring Festival holiday and continue working on-site, as this period marked a critical juncture for Infervision in its application for CE certification of medical devices under EU regulations. He needed to closely monitor the latest developments in the review process.
On February 24, local time, upon seeing the long-awaited certificate officially approved, Sun Yipeng finally felt relieved. He immediately announced to the company that Infervision’s AI product, InferRead, had obtained CE certification.
This marks the first EU CE certification for a chest AI product in China, signifying a substantive breakthrough for medical AI’s global expansion. It also underscores Infervision’s position as a pioneer in the internationalization of Chinese medical AI, formally launching the global market access and commercialization of its AI products.
Since the emergence of medical AI, Chinese medical AI companies have been at the forefront, whether in remote areas of Africa or in Europe, one of the central hubs of the healthcare market. This time, a company has finally succeeded in making its breakthrough.
It took Infervision more than a year to establish its European division and obtain CE certification. For Sun Yipeng and the core team at Infervision, although they were fully confident, no one dared to relax until the very last moment. Securing CE certification was tantamount to obtaining a passport to enter and penetrate the European market.
In the European market, characterized by developed economies and a severely aging population, lung cancer ranks as the third most common cancer and is the leading cause of cancer-related deaths. Furthermore, Europe constitutes the second-largest market for computed tomography (CT) scanners globally, with lung cancer accounting for nearly 20% of all cancer cases in European countries.
Clinical access systems in developed countries are highly sophisticated. The European market has long been characterized by high barriers and stringent entry requirements, resulting in a limited number of Chinese-made medical devices successfully entering the market. In Europe, there is growing attention on the application of artificial intelligence for AI-assisted lung cancer diagnosis, early disease screening, and low-radiation CT scanning.
Mr. Sun Yipeng, Head of Infervision’s European Division, stated that Europe has a population of approximately 500 million. Based on U.S. rates, there are an estimated 14 million individuals eligible for early lung cancer screening, which would generate an AI-driven lung cancer market worth approximately €1 billion. Currently, Europe is placing increasing emphasis on early lung cancer screening, as early detection and treatment can significantly reduce healthcare costs for the entire medical system.
Currently, the InferRead™️ CT Lung product assists physicians in completing nearly 50,000 clinical diagnoses per day. It enables efficient image interpretation and identification of minute nodules; provides intelligent follow-up and treatment efficacy assessment; builds an intelligent case database to offer smart references for precise clinical decision-making; generates automated structured reports; and supports customization of various personalized report templates.
On February 12, the European Society of Radiology (ESR) and the European Respiratory Society (ERS) jointly issued a statement calling for the implementation of low-dose CT lung cancer screening across Europe, and released the “Joint White Paper of the European Society of Radiology and the European Respiratory Society on Lung Cancer Screening (LCS).”
Upon obtaining CE certification, Infervision will illuminate its commercialization map in Europe. For medical AI, market access has always been a focal point, as large-scale commercialization of AI in healthcare becomes feasible only after securing market access qualifications. By breaking through the barrier of Class III medical device review and approval, medical AI will have room to explore business models and overcome bottlenecks in the development of the medical AI industry. However, whether domestically or internationally, regulatory approval for chest imaging AI remains restricted.
Infervision’s acquisition of CE certification has pioneered the commercialization of medical AI, establishing a first-mover advantage in the European market.
Infervision has endured numerous hardships and challenges to secure this CE certification, a crucial stepping stone.
In fact, the EU is currently in a transitional period between its old and new medical device regulations, leading to a backlog of application materials and significantly reduced approval efficiency. In this context, Infervision, through meticulous planning and preparation, assembled a core project team comprising members from diverse departments and professional backgrounds. The team overcame various challenges, including parallel multitasking, time zone differences, and language barriers, to become the first to obtain AI certification for chest imaging, thereby securing a competitive advantage in the European market once again.
AI’s global expansion is an adventure fraught with challenges, requiring adaptation to local regulatory policies and cultural systems. Furthermore, as a new technology, it will take prolonged effort to overcome traditional perceptions and barriers associated with Chinese products.
As early as November 2018, Sun Yipeng’s team had already initiated implementation partnerships for chest imaging AI across various European countries. This not only marked a first for Chinese AI but also placed it ahead of many local European AI products. In Europe, Infervision AI underwent a transition from skepticism to acceptance, establishing robust trust and in-depth collaboration with partner hospitals. Although most European hospitals adhere to standardized protocols and maintain high standards of care, they still regard Infervision AI as an indispensable clinical decision-support tool and a foundational platform for scientific research. With its strong technical capabilities, Infervision AI has earned the recognition of European hospitals, changing the perception of Chinese technology and products in many overseas countries.
Chen Kuan, Founder & CEO of Infervision, believes that the successful approval of the CE certification reflects Infervision’s comprehensive strength: on one hand, it is due to Infervision’s profound accumulation of product technology, with products developed based on real clinical needs; on the other hand, it is attributed to the exceptional execution capability of the Infervision team.
Currently, Tuixiang AI has been deployed in more than ten medical institutions across Germany, France, Switzerland, and Spain, including top-tier hospitals in both clinical care and scientific research. Notable examples include the University Hospital Zurich, one of Switzerland’s largest hospitals with 48 departments, and the University Medical Center of Mainz in Germany, a globally leading institution in oncology with 1,500 beds.
Amid an uncertain domestic market, unclear business models, and intensifying competition during a capital winter in the medical AI sector, Infervision has defied the headwinds to launch its global commercialization of AI.
Infervision recognizes that healthcare is a long-cycle industry, requiring strategic planning 3–5 years in advance. Therefore, Infervision has proactively expanded into overseas markets and pursued medical AI regulatory approvals in multiple countries, while continuously leveraging the experience and product insights gained from international implementation to benefit the domestic market.
Globalization, in essence, is glocalization. The value propositions of medical AI vary across different markets. Infervision believes that the core healthcare demand in developed countries lies in leveraging AI technology to control or even reduce healthcare costs, whereas the primary challenge in developing countries is the scarcity of medical resources and talent.
Infervision has established a presence in multiple countries. Through its global AI initiatives, Infervision has emerged as a pioneer in advancing medical AI into North America, Europe, and Africa.
Undoubtedly, North America, Europe, and Japan represent the pinnacle of the global healthcare industry, as well as the world’s largest healthcare and medical AI markets. For Infervision, a Chinese AI company with global ambitions, CE marking is merely the first step. Chen Kuan revealed that Infervision is simultaneously advancing market access for its medical AI products in overseas regions, particularly in these key markets.
In Africa, the Ethiopian Ministry of Innovation and Technology has signed an agreement with Infervision to advance cooperation in areas such as artificial intelligence infrastructure, algorithm research, data applications, multi-scenario development, and scientific research incubation, thereby introducing AI multi-scenario application technologies to Ethiopia and the broader African continent.
Unlike other “fast-paced” industries, Infervision has, since its inception, undergone the same lengthy cycles and substantial investments as other medical companies to refine its high-quality products through rigorous iteration. The approval of medical regulatory clearances will transform these significant upfront investments into competitive barriers and entry thresholds, granting the company a substantial advantage.
The commercialization of medical AI is about to begin, not only in China but around the world.