VoxelCloud Accelerates Commercialization with NMPA Class III Approval for Chest CT AI and Files IPO Prospectus
On November 23, 2021, the National Medical Products Administration (NMPA) officially approved the Class III medical device registration for Suzhou Tisu Information Technology Co., Ltd. (hereinafter referred to as “Tisu Tech”)’s “CT Imaging Auxiliary Triage Software for Pulmonary Nodules,” which is based on deep learning technology. Tisu Tech became the fourth medical AI company in China to obtain regulatory approval for an AI-based pulmonary nodule detection solution.
Image source: National Medical Products Administration
Founded in 2016, VoxelCloud is among the first batch of medical imaging AI companies in China. Since its inception, the company has recognized that the value of AI-assisted diagnostic systems in healthcare lies in two key areas: first, empowering basic screening and diagnosis in straightforward scenarios, such as health check-ups and primary care support; second, tackling tasks that are difficult for humans to perform, such as precise quantification of lesions and anatomical structures, simulation modeling, and insurance cost containment leveraging big data. By 2019, the company had already developed a multi-disease solution matrix covering multiple body sites, including the lungs, eyes, and skin, and simultaneously initiated commercialization in both domestic and international markets.
Obtaining AI registration for pulmonary nodules is of great significance to VoxelCloud, as it means that VoxelCloud’s pulmonary nodule product can be officially used in clinical practice, and it also lays the foundation for the regulatory approval and registration of its expanding product portfolio.
In recent years, the rising health awareness among residents has driven up the demand for medical checkups, leading to an increase in the volume of medical imaging. Healthcare institutions must meet the growing patient demand while maintaining the quality of each examination. In this process, AI can play a significant role in standardization.
VoxelTech has not lagged in its deployment within health checkup centers. It is reported that VoxelTech entered into a strategic partnership with iKang Healthcare Group in mid-October 2021, with its technical solutions to be implemented in over one hundred iKang health checkup centers nationwide. Currently, VoxelTech’s AI product for pulmonary nodule detection, specifically developed for health checkup scenarios, has been officially launched and is operational on iKang’s Imaging Cloud System. Meanwhile, its multi-organ, multi-disease auxiliary detection product for chest CT imaging is undergoing trial operations. By analyzing extensive health checkup report data, VoxelTech has identified 14 common pathological conditions—including pulmonary nodules, fractures, bullae, hepatic cysts, and gallstones—as key areas for technological breakthroughs. Its products cover lesions in multiple organs such as the lungs, liver, gallbladder, and kidneys, effectively detecting 92.6% of lesion types encountered in health checkup settings.
In response, Dr. Wang Zhaohui, Vice President of Product at iKang Guobin Group, stated: “iKang Guobin is committed to the quality and scientific rigor of its health examination services. By leveraging Tisu Technology’s AI-assisted diagnostic system for pulmonary nodules, we aim to enable our physicians to detect every pulmonary abnormality in patients more quickly and accurately, while effectively optimizing their workflow experience.”
In recent years, Voxel Technology’s other product portfolios have been adopted by more than 850 hospitals in China, with its internet-based services reaching over 20 million users. The company has also entered into partnerships with the two largest vertical health maintenance organizations (HMOs) in the United States to deploy risk assessment and cost-containment systems for major diseases affecting the heart, brain, kidneys, and lungs.