Xiamen Manteia Data Technology Secures FDA Approval for AI-Powered Radiotherapy Imaging Workstation AccuContour

Recently, VCBeat learned that AccuContour, an AI-based radiotherapy imaging workstation independently developed by Xiamen Manteia Data Technology Co., Ltd. (“Manteia”), has recently received approval from the U.S. FDA.This is the first AI-based radiotherapy imaging workstation and auto-segmentation software from China to receive FDA clearance.

As the first AI software in the field of radiation therapy to receive FDA clearance in China, what clinical problems does it primarily address? What are the key considerations for regulatory approval abroad? In response to these questions, Zhou Qichao, Founder and CEO of Manteia, sat down for an exclusive interview with VCBeat.

Approved Product: AccuContour

The newly approved product, AccuContour, is an AI-powered radiotherapy imaging workstation and a critical tool for treatment planning design, serving as an effective complement to current planning systems. Its core functionality is the automatic delineation of target volumes based on multimodal imaging (CT/MR), which reduces the delineation time from 1–3 hours to mere seconds. It enables automatic delineation of over 70 organs at risk (OARs) and six tumor regions, achieving a Dice similarity coefficient of 0.85–0.95. Upon completion of delineation, the system performs automated quality assurance (QA) and automatic correction of the results.

Furthermore, AccuContour incorporates a registration module that overcomes the accuracy and speed limitations of existing algorithms. It allows users to select target volumes, organs, or custom regions for different registration modes based on clinical needs, with deformable registration completed in 3–5 seconds. To meet the demands of clinical research, AccuContour is equipped with powerful image analysis tools, along with radiomics analysis and statistical functions. With the implementation of novel algorithms and enhanced automation, AccuContour also features automated unattended operation and control capabilities, freeing physicians from being tethered to their workstations.

CEO Zhou Qichao told VCBeat that the primary value of AccuContour lies in, first,Provide efficient and precise tools for radiation therapy planning, enhancing clinical workflow efficiency by reducing the time required for target volume delineation from hours to minutes or even seconds. Secondly, it facilitates the standardization and uniformity of radiotherapy target volumes.。

Manteia’s current main product lines include the “Automatic Target Delineation System,” “Safety and Quality Control System,” “Online Adaptive Radiotherapy Planning System,” and “Information and Control System.” The objective is to enable real-time adjustment of treatment plans in response to changes in the patient’s target volume during radiotherapy—caused by various positional variations such as physiological motion, setup errors, weight fluctuations, and tumor response—thereby achieving adaptive radiotherapy.

The U.S. Food and Drug Administration (FDA) is widely recognized as having the world’s most stringent standards and most comprehensive regulatory framework, with its product reviews placing near-rigorous emphasis on software safety and clinical effectiveness.

AccuContour is the first AI-based radiotherapy product in China to undergo regulatory submission for classification, facing challenges such as unclear review standards and ambiguous definitions of testing requirements.To secure approval, the company began by gaining a thorough understanding of the U.S. FDA regulatory framework and preparing the necessary documentation. Through dozens of communications with reviewers and experts, it continuously refined and optimized its product and testing processes. In collaboration with five partner hospitals, the company successfully completed data collection, model training, and testing for hundreds of cases. The outstanding results earned clinical recognition and ultimately led to regulatory approval.

Zhou Qichao stated that AccuContour is undergoing simultaneous regulatory reviews in the United States, China, and Europe. Securing FDA approval first serves as a significant encouragement to the company’s development and represents a solid step forward in its globalization strategy.

Manteia is a research and development company specializing in radiation therapy systems, leveraging deep learning and traditional algorithmic research.Secured tens of millions in seed funding from Fosun Group in 2018, and successfully completed Series A financing in 2019.. The R&D team comprises 10 PhDs and 11 Master’s degree holders, hailing from renowned domestic and international institutions as well as the Adaptive Radiation Therapy Research Group at the Medical College of Wisconsin. It has established joint R&D collaborations with dozens of leading research institutions both in China and abroad, including the Medical College of Wisconsin, Mayo Clinic, University of Chicago Medicine, Chinese PLA General Hospital, and Peking Union Medical College Hospital. The team has participated in more than 10 international collaborative projects and over 60 clinical trials, and holds two international patents related to adaptive technology.

In recent years, with the rapid advancement of data and algorithm technologies, the integration of healthcare and technology has become increasingly close, with products progressively achieving intelligence and automation. Additionally, driven by the rapid growth of the radiotherapy market, the Chinese government has successively introduced plans and policies to encourage the development of the radiotherapy industry, vigorously promote technological innovation, and accelerate the substitution of imported medical devices with domestically produced alternatives. Against this backdrop, numerous outstanding enterprises have emerged in China.

Zhou Qichao stated that as a medical company, it is essential to remain grounded and rigorous while holding science in high regard. While commercial value is important, we must recognize that the responsibility entrusted to us by patients’ lives carries immense weight. By leveraging technology to infuse warmth into both commerce and healthcare, staying true to our original mission, and forging ahead with determination, we can look forward to a promising future.