Lianxin Medical's AI-Powered Cloud Contouring System Receives NMPA Class III Certification, Accelerating Nationwide Commercial Rollout
“AiContour, the intelligent cloud-based contouring system independently developed by Lianxin Medical, obtained Class III medical device registration certification from the National Medical Products Administration (NMPA) at the end of August. As the first intelligent cloud-based contouring system to receive Class III certification, AiContour has been deployed in more than 50 hospitals, serving over 2,000 patients weekly. Since obtaining the certification, the product has entered the bidding processes of multiple hospitals and is undergoing cooperation negotiations with distributors across various regions in China. It is expected that the product will soon be rolled out to nearly 1,000 hospitals nationwide.。”
As the first intelligent cloud-based contouring system to receive Class III certification, Zhang Hua, founder and CEO of Defiled Medical, expressed strong confidence when discussing the company’s commercial progress following the product’s approval.
It is well known that high-quality medical services in China have consistently failed to meet patient demand. This is particularly evident in the field of radiation therapy, where, despite over one million patients requiring treatment annually, there were only 15,841 radiation oncologists and 3,294 medical physicists in China in 2015 (data source: Survey on the Basic Status of Radiation Therapy in Mainland China, 2015), far insufficient to meet patient needs.
Moreover, in radiotherapy, the accuracy of target volume delineation is a decisive factor determining the quality of the treatment plan. However, due to a shortage of skilled professionals, few physicians are proficient in performing precise target delineation, and each treatment plan requires 3–5 hours for this process.
Therefore, with technological advancements, multiple companies are developing intelligent contouring systems to “replicate” the capabilities of expert radiation oncologists, thereby reducing treatment time for patients and enabling hospitals to provide more radiotherapy services.
Currently, intelligent target volume delineation tools on the market do provide significant assistance to physicians; however, existing products still have many shortcomings. The first issue concerns compatibility and ease of use. Many current intelligent target volume delineation solutions are standalone workstations that require installation on physicians’ terminals, leading to certain compatibility and operational convenience issues.
Second, as a standalone system, it poses challenges for collaboration among hospitals and departments. Particularly in the current context of strengthening primary healthcare, if seamless coordination cannot be achieved, specialists from tertiary hospitals will find it difficult to provide services to primary care institutions through the system.。
Furthermore, in the field of radiation therapy, physicians currently operate in a fragmented manner when delineating target volumes. Although expert guidelines exist, quality control remains a significant and long-term challenge.
Addressing the current pain points and deficiencies, Defiled Medical has taken the lead in achieving a breakthrough by developing an intelligent target delineation system based on internet and cloud platforms. By migrating the intelligent target delineation product to the cloud, it not only resolves issues related to compatibility, convenience, and collaboration but also significantly advances radiotherapy quality control efforts, thereby enhancing the precision of radiotherapy across China.
Radiotherapy Workflow and Quality Control
The product certified as a Class III medical device by Defiled Medical is named “Radiotherapy Contouring Software.” According to the registration certificate, this product is primarily used for contouring tumors and related organs and tissues prior to radiotherapy planning.
Product Features include two components: (1) Server: Computer scheduling service, DICOM transmission management service, Web service, data storage and management. (2) Client: System login, device management, quality control management, hospital information, user management, department management, role management, DICOM service, image viewing, target delineation, dose display.
In China, the market is not short of target delineation products due to a long-standing shortage of skilled radiation oncologists. Zhang Hua told VCBeat that, compared with previous intelligent target delineation systems, AiContour has its own unique advantages:
First,This product enables remote delineation of target volumes via the Internet and cloud platforms, allowing physicians to perform remote delineation without installing any dedicated software.。
Previous intelligent target volume delineation systems were mostly standalone workstations that could only be used on fixed computers. Defiled Medical’s product leverages an internet-based cloud platform to enable intelligent delineation, allowing physicians to access the system’s functions anytime, anywhere, and across platforms. Regardless of the computer brand or operating system used, physicians can log in and utilize the system’s features as long as they have a web browser.
Second,Intelligentization enhances physicians' contouring efficiency, offering greater potential for their professional development.。
AiContour reduces the time required for target volume delineation from several hours to under 20 minutes. This is not merely a matter of improving efficiency; it liberates physicians from tedious, repetitive tasks. With this freed-up time, doctors can engage in patient support, education, and scientific research, allowing them to fully unleash their professional potential rather than being bogged down by monotonous, routine work.
The Significance of Automatic OAR Delineation
Third,Good compatibility facilitates extensive clinical adoption and data accumulation.On the physician side, doctors can access this system simply by installing a web browser on their computers, regardless of whether they are running Microsoft Windows or Apple macOS. On the equipment and IT infrastructure side, Lianxin Medical’s system is compatible with imaging devices and linear accelerators from various manufacturers.
Prior to obtaining its Class III medical device certification, Defiled Medical’s system had already established clinical collaborations with more than 50 hospitals across China and had long achieved compatibility with their respective equipment and information systems.Furthermore, leveraging over 26,000 data points accumulated through collaborations with various hospitals, and incorporating extensive feedback from physicians during these partnerships to rigorously refine the product, we have ensured its seamless integration into clinical workflows.。
Currently, more than 2,000 patient radiotherapy target delineations per week are completed with the assistance of this system from Defiled Medical.
Jia Yongshi, Director of the Department of Radiation Oncology at Zhejiang Provincial People's Hospital, uses the intelligent cloud contouring system AiContour in clinical practice.
In addition to improving physicians' work efficiency and the accuracy of target volume delineation,The significance of intelligent system-based delineation lies in establishing a consensus on delineation, ultimately constructing a high-quality and generalizable standard for intelligent delineation.
As a leading enterprise in the field of AI for radiotherapy, Defiled Medical is actively promoting the development of AI-based standardized contouring in radiotherapy.This includes collaborating with partner hospitals to provide corresponding data for scientific research, and developing an expert consensus on standard radiotherapy target delineation based on expert experience. Relying on this expert consensus, the data are processed in a standardized manner to train models, ultimately establishing a set of standards.
Zhang Hua stated that there is indeed an expert consensus in clinical practice regarding the delineation of target volumes for organs. However, the original expert consensus was presented in textual descriptions.
Lianxin Medical transforms textual descriptions into tens of thousands of actual physician-annotated results, converting the original imprecise, non-quantitative text-based expert consensus into a quantifiable and computable image-based expert consensus.
Zhang Hua told VCBeat,The development of this “image-based” expert consensus and contouring standards holds significance far beyond that of a single product. The establishment and promotion of these standards will greatly advance the standardization of normal tissue and organ contouring in radiotherapy across China. The radiotherapy contouring software recently approved for market entry will provide technical support for this consensus and the associated standards. Furthermore, Defiled Medical welcomes peers to actively join efforts to accelerate the implementation of AI-driven standardized contouring projects. Meanwhile, Defiled Medical will compliantly and legally open up a portion of its data for research by scientists worldwide.。
Prior to obtaining Class III certification, Lianxin Medical’s business profitability model was still in the exploratory phase. With the certification secured, the vision has become a reality. Zhang Hua stated,Currently, Defiled Medical's revenue model consists of two types.：
The first type,Direct sales of approved radiotherapy contouring software to Grade 3A hospitals will constitute the core revenue stream for Lianxin Medical. The product has currently entered the hospital tendering process.。
Regarding the sales model, Zhang Hua told VCBeat,The company team will maintain a small-scale sales team., primarily serving hospitals with research needs and refining products through in-depth collaboration with these institutions.Nationwide product sales will be conducted in collaboration with professional channel companies.. After all, specialization matters; Defiled Medical’s vision is to harness artificial intelligence for the benefit of humanity, enabling safer and more efficient tumor radiotherapy.
The second type,Remote Radiotherapy Collaboration Services. Based on its independently developed AiTeam Oncology Collaboration Platform, Defiled Medical will collaborate with radiation oncology experts or third-party radiotherapy centers to provide services to primary-care hospitals at the county and municipal levels, thereby establishing specialized oncology medical consortia. This initiative aims to assist primary-care hospitals in enhancing their radiotherapy capabilities and to promote the implementation and practical application of the tiered diagnosis and treatment system.
After primary-care hospitals join the AiTeam Oncology Collaboration Platform, patient imaging data can be directly uploaded to the server for intelligent automatic delineation. Expert physicians are responsible for confirmation and review, and the reviewed target volume delineation images, along with the treatment plan, are then transmitted back to the primary-care hospitals.
Through remote radiotherapy collaboration, we can not only help primary-care physicians improve their diagnostic and treatment capabilities, but also enable cancer patients to access high-quality radiotherapy services without leaving their counties. Currently, the AiTeam Oncology Collaboration Platform serves more than 200 patients per month; with product approval, it will be rolled out across China more rapidly.
It should be emphasized that remote collaboration in radiotherapy services can only be achieved through the internet and cloud platforms.
In the final remarks, Zhang Hua emphasized: “The approval of the AiContour intelligent contouring system has injected confidence into the commercialization path that medical AI companies have been exploring for years, validating prior commercialization hypotheses. We believe that the efforts made over the years will gradually yield returns.” [Note: This NMPA certificate is not an AI-class medical device certificate.]