Definition of AI Medical Device
As defined by FDA, software as a medical device is any software that meets the legal definition of a medical device and includes one or more software components, parts, accessories or instruments consisting solely of software.
As defined by the EU, medical device software provides information processing for one or more of the medical purposes listed in the intended use of a medical device, such as diagnosis, prevention, monitoring, quality, or mitigation of disease, and Artificial Intelligence (AI) medical device software applies to software that provides diagnosis or treatment on its own as well as software that only provides information intended to inform professionals in making a final diagnostic or treatment decision.
In March 2022, China's National Medical Products Administration formally characterized AI medical devices as those rooted in medical device data and utilizing AI technology to fulfill their intended purposes.
Medical device data encompasses objective information generated by medical devices for medical applications, including medical image data from imaging devices, physiological parameter data from electronic devices, and in vitro diagnostic data from diagnostic devices.
The development of AI Medical Device in China
The swift evolution of the Internet, big data, cloud computing, and other emerging technologies has led to the widespread adoption of AI in clinical assistance, diagnosis, and treatment within imaging and pathology. Serving as a crucial pillar of modern medicine, the imperative integration of AI with laboratory medicine is evident.
The AI medical device market in China, though initially slow to emerge, has witnessed rapid development in recent years, transitioning from its early stages. From 2019 to 2022, the market experienced substantial growth, surging from $124.7 million to $1,155.6 million at an impressive Compound Annual Growth Rate (CAGR) of 110.1%. Projections indicate a continued expansion, reaching an estimated $75,568.8 million by 2030, albeit with a moderated CAGR of 39.2%, signaling a deceleration in market growth.
A recent update on the Chinese government website highlights a strategic emphasis on advancing the future health industry. Pivotal to this effort are innovative initiatives in areas like AI and technology-driven novel medical services, as well as the research and development of sophisticated medical equipment integrating advanced technologies such as digital twin brain-computer interaction.
As of 5 July 2023, NMPA has granted approval for 70 Class III certificates for AI medical imaging. These certificates span two distinct categories, covering both assisted diagnosis and treatment processes. Assisted diagnosis encompasses conditions like coronary arteries, pulmonary nodules, bone fractures/osteopathy, and fundus evaluations. Meanwhile, assisted treatment primarily involves products related to radiation therapy.
Data unveiled at the 2022 Medical Artificial Intelligence Conference indicates a prevalent adoption of AI products, with 74% of tertiary hospitals, 32.5% of secondary hospitals, and approximately 10% of primary institutions incorporating these technologies.
Notably, between 31 August 2022, and 31 October 2023, the medical AI sector witnessed a total of 170 financing rounds, amassing a substantial funding amount of RMB 16.124 billion.
Strategic integration of AI by leading medical device companies
Major medical device companies are actively venturing into the realm of AI integration.
Mindray, since 2009, has been strategically exploring the fusion of AI across its three primary product lines encompassing medical imaging, in-vitro diagnostics, and life information and support. The company has progressively introduced more intelligent functionalities aimed at supporting hospitals and healthcare professionals in achieving precise diagnosis, efficient treatment, and streamlined management through advanced information technology applications.
On 6 September 2023, Roche China announced its official partnership with Deep Informatics. Together, they will introduce an AI-assisted interpretation algorithm product tailored for pathology. This collaboration is poised to advance the digitization and intelligent transformation of pathology diagnosis in China, offering robust support for the evolution of personalized precision diagnosis and treatment.
On the evening of 9 January 2024, iFLYTEK made a formal announcement regarding the spin-off of its medical device company for listing on the Hong Kong stock market. The company initiated projects such as the Smart Medical Assistant¡ªa diagnostic and treatment robot¡ªand the AI-assisted diagnosis and treatment platform. These initiatives aim to seamlessly integrate AI technology with the medical industry.
