World’s First Class III Approval for a Breakthrough Medical Imaging AI: Diagens AI AutoVision®

World’s First Class III Approval for a Breakthrough Medical Imaging AI: Diagens AI AutoVision® Passes Highest-Level Regulatory Validation, Strengthening Its Technological Moat

HANGZHOU, China, May 27, 2026 (GLOBE NEWSWIRE) -- On May 22, Hangzhou Diagens Biotechnology Co., Ltd. announced that its proprietary AI AutoVision® Chromosome Karyotype Assisted Diagnosis Software has officially obtained a Class III Medical Device Registration Certificate from China’s National Medical Products Administration (NMPA). This marks one of the fastest approvals globally for a pioneering medical imaging AI product in fields such as birth defect prevention and assisted reproduction, and represents validation under China’s highest-level medical device regulatory framework.

Class III certification is the highest regulatory approval level for medical devices in China, with the strictest approval standards and the highest clinical validation requirements, often regarded as the “highest-level pass” for AI medical devices. AI AutoVision® had previously entered the Innovative Medical Device Special Review Channel (“Green Channel”), recognized by the NMPA as an innovative product. Its formal approval signifies that the product has completed full regulatory validation from “innovation recognition” to “compliant market approval.”

For investors, the value of this certification lies in three dimensions of scarcity: global first-of-its-kind status, highest-level regulatory access, and the first regulatory validation of a foundation model — an unprecedented combination among Hong Kong-listed companies.

“Global First”: An Undervalued Entry Point into a New Market

AI AutoVision® operates in the chromosome karyotype analysis sector, a foundational diagnostic step in birth defect prevention and assisted reproduction, directly linked to prenatal diagnosis and infertility treatment.

However, this field has long faced structural supply bottlenecks: Under traditional workflows, clinicians must manually identify, count, and arrange 46 chromosomes under a microscope, with each case taking approximately 34 minutes on average and report cycles reaching approximately 30 days. Training a qualified karyotype analyst requires 3–5 years, resulting in a persistent shortage of specialized personnel.

Powered by Diagens’ iMedImage® medical imaging foundation model and proprietary AI algorithms, AI AutoVision® enables one-click chromosome segmentation, counting, arrangement, and case-level abnormality detection, upgrading the workflow from “manual interpretation” to “AI automated analysis + physician review.” A 1,734-case multicenter prospective clinical trial demonstrated: sensitivity and specificity of 100% for numerical abnormality detection; sensitivity of 94.31% and specificity of 100% for structural abnormality detection; average analysis time reduced from 34.42 minutes to 11.19 minutes; report turnaround time reduced from approximately 30 days to 4–7 days; and automated analysis accuracy exceeding 99%.

This is one of the largest multicenter clinical trials in chromosome karyotype AI diagnostics globally. In terms of scope and sample size, it is rare among AI medical device approvals. The dual 100% results for sensitivity and specificity in numerical abnormality detection mean that, on this core metric, AI has achieved performance equivalent to or even better than senior analysts — representing not incremental improvement, but a fundamental substitution of the service model.

“Highest-Level Approval”: Regulatory Barriers as Competitive Moats

The difference between Class III and Class II certification is not only hierarchical, but also reflects a significant difference in market access barriers.

Class III certification requires rigorous multicenter clinical trials to demonstrate safety and effectiveness, with approval cycles typically measured in years. It imposes extremely high requirements on algorithm interpretability, data compliance, and cybersecurity. In contrast, Class II certification has relatively looser clinical validation requirements and shorter approval cycles.

This means that Class III-certified products gain significant first-mover advantages in market access, hospital procurement, and reimbursement pathways that Class II products cannot match. The approval of AI AutoVision® directly opens large-scale hospital deployment channels and lays the foundation for future inclusion in medical insurance payment systems.

For competitors, completing the full cycle of R&D to clinical trials to Class III approval typically requires 2–3 years, creating a substantial time-based competitive barrier for Diagens in the chromosome karyotype analysis sector.

“Foundation Model Validation”: The Value of One Certificate Extends Far Beyond a Single Product

The Class III approval of AI AutoVision® validates not only the product itself, but also the underlying iMedImage® medical imaging foundation model behind it — as one of the most comprehensive medical imaging foundation models globally, the model contains 104 billion parameters, supports 19 imaging modalities, and covers more than 90% of clinical imaging scenarios.

The core logic of a foundation model is “one validation, system-wide replication.” The approval of AI AutoVision® demonstrates that products built on iMedImage® can pass the highest level of regulatory scrutiny, transforming the foundation model from a research tool into a commercially deployable infrastructure.

Over the past six months, Diagens has partnered with 65 leading hospitals to incubate 92 cutting-edge imaging models, covering 32 human organs and 64 disease areas. With the first Class III approval, subsequent approval pathways are expected to further accelerate, with approval timelines shortening further.

Across China’s more than 3,200 and approximately 5,000 global medical imaging testing categories, this marks a shift from a “product company” to a “platform company,” fundamentally changing valuation logic.

Investment Logic: From “Selling Devices” to “Selling Capabilities”

Diagens' 2025 annual report data already shows this trend. Full-year revenue reached approximately RMB 164 million, representing year-over-year growth of approximately 134%. Technology licensing revenue reached RMB 84.3 million, surging 331.7% year-over-year and becoming the company's largest revenue source for the first time, accounting for more than 50% of total revenue.

This structural change reflects that Diagens' growth engine has upgraded from single-point "equipment + software" delivery to a higher-margin integrated model centered on "device entry points + model platform + technology licensing." The increase in licensing revenue indicates the industrialization of foundation model capabilities.

Currently, the company’s products have been deployed across more than 400 medical institutions nationwide, with leading market share in chromosome karyotype analysis — firmly ranked first in China. With the Class III approval of AI AutoVision®, the channel for large-scale hospital adoption is now open, and the revenue growth driven by this core product is expected to accelerate further.

According to Frost & Sullivan, the global AI medical imaging market is expected to grow from approximately USD 1.6 billion in 2024 to USD 9.3 billion by 2030, while China’s core AI medical imaging market is expected to expand from approximately RMB 2.4 billion to RMB 40.1 billion. As one of the first companies to successfully navigate the full chain from “foundation model Class III product licensing revenue,” Diagens stands at the starting point of this industry expansion.

Media Contact

Company: Hangzhou Diagens Biotechnology Co., Ltd.
Contact Person: Zhe Wang
Email: zhewang@diagens.com
Website: https://www.diagens.com/about?lang=en

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