Shukun Technology Secures Three Key Certifications in One Week, Signaling Maturity of the Medical AI Sector

On December 3, SHUKUN, a leading enterprise in medical artificial intelligence, obtained Class III review and approval for its AI-powered CT imaging triage and assessment software for pneumonia. Just six days later, the company secured two CE certifications for its AI-assisted diagnostic software for head and neck conditions and for pulmonary nodules. Within two weeks, SHUKUN obtained three regulatory approvals in succession.

The underlying reason is that the increasingly mature regulatory review and approval pathways for AI products, both domestically and internationally, have provided AI companies with clearer directions for product development and clinical trial design. Meanwhile, AI products themselves have reached a sufficient level of maturity through continuous daily use and recognition across thousands of hospitals.

This change has directly impacted the commercialization of AI in medical imaging.

The 2021 Medical Artificial Intelligence Report, “On the Eve of IPO: The Sprint and Shifting Landscape of Medical AI,” provides an overview of the commercial momentum behind imaging AI. Based solely on publicly available bidding data, imaging AI solutions accounted for 23.9% of all smart healthcare applications procured by hospitals.

Statistics on the Types of Medical AI Products Purchased by Hospitals (Data Source: "On the Eve of IPO,HealthcareThe Sprint and Disruption of AI》)

Nowadays,Imaging CarrierAI's Many Glorious Moments2021GoneBy year-end。The New Year，It is a continuation of past glory and ongoing development.，Still stalled at the crossroads, contemplating new directions，We may need to return to policy、Funding、Three Pillars of Technology，Search for Medical ImagingThe Next Phase of AI Development May。

Generally speaking, for an AI-based medical device product to successfully achieve large-scale commercialization, it must sequentiallyViaRegistration Access, Pricing Approval, and Medical Insurance Reimbursement Access.But inThe First Five Years of AI’s Hesitant Advance，The registration and market access overseen by the National Medical Products Administration (NMPA) has always beenThe Insurmountable Hurdle for AI Companies。

Standard、The Gradual Improvement of the Approval Process for ImagingAI Development Provides Direction and Assurance，and imagingAI itself is also becoming increasingly mature as corporate research continues to deepen.。2020Year6One Month Later，ImagingAI Obtaining NMPA Class III Certification Has Become the Norm。

After the self-registration approval process is successfully completed，Airdoc2020Annual revenue for the year increased compared to last year.5Cheng；Infervision's Annual Growth318%；SHUKUN has even doubled.32Times，revenue in the first half of the year exceeded500010,000。

In the long term，NewAIWill not be like pneumonia、Pulmonary Nodules、Diabetic Retinopathy, etc.General AI，With several years of implementation experience。After the process is successfully executed，NewAIMust pass three access approvals one by one.，to achieve commercial monetization more rapidly。

Meanwhile，Overseas markets have also become a key battleground for companies to compete for this year.。Taking SHUKUN as an example，This company was established in12Month3Acquired PneumoniaCT Imaging-Assisted Triage and Assessment Software After Class III Review and Approval，AlsoInDecember9Day Secured Head and NeckAI-Assisted Diagnostic Software and AI-Assisted Diagnostic Software for Pulmonary NodulesTwo sheetsCE Certification，First-mover entry into the European market。

Outlook2022Year。On the one hand,，ExistingAI ProductsAttempt to access the fee schedule,NewAI ProductsSustained Efforts in RegistrationMarket access will become medical imagingKey Focus Areas for AI Enterprises。Under Mature Products and Comprehensive Approval Processes，More New ImagesAI Products Poised for Faster Hospital Adoption，ImagingAI May Be Poised for a New Wave of Development。

On the other hand,，As SHUKUN and other enterprises increasinglyAI Products Gain Market Access in Overseas Markets，China ImagingAI has the potential to open a second front in developed countries such as those in Europe and the United States.，Effectively expand its addressable market。

2020: A Turning Point for the Medical AI Industry，Medical AI companies that weathered the capital winter are now ushering in an industry spring. According to data from VCBeat, medical artificial intelligenceof2020YearTotal completed97 financing rounds, with 84 disclosing the amounts raised, involving a total of RMB 16.04 billion.

2021The race track is even hotter this year。VCBeat Data Shows，As ofIn August 2021, the medical AI sector completed 108 financing rounds, with 89 of them disclosing specific amounts, totaling RMB 16.718 billion.。

The agglomeration effect of capital from2020became apparent starting in the year，This Year, certified enterprises such as SHUKUN and Keya Medical are able to secure financing multiple times a year, whereas a large number of uncertified and emerging companies struggle to obtain capital support.

Arrived.2021Year, few startups haveImagingAI forDirection: Entering the Field of Medical Artificial Intelligence.However, in terms of the head,Keya Medical、Infervision、SHUKUN and Two Other Companies Successively File Prospectuses，Deepwise Medical Acquires Yitu Healthcare，Airdoc Rings the Bell at the Hong Kong Stock Exchange...these developments all underscore the increasingly pronounced trend of industrial agglomeration.。

Some scholars have pointed out: In recent years, imagingThe Matthew Effect in AI is becoming increasingly pronounced,HeadEnterprises continue to secure substantial financing and refine their production line layouts, in stark contrast to latecomers, who face significant challenges in raising capital and experience sluggish growth.

For ImagingIn terms of the AI sector,Diagnostic services for a variety of diseases provided toEnterpriseAbundant Business Opportunities，Leading Enterprises in Rapid Market Penetration，and continuously achieve breakthroughs in large-scale commercialization, whileCapital AggregationofStrengthcan be moreEffectively accelerateThis process。

We can observe the various mature business models that have emerged during this process.，If SHUKUN willAICoveringXRadiographs,CT, MRI and other important examination scenarios, andExtensive Deployment in Hospitals，OptimizationCritical conditions such as cardiovascular and cerebrovascular diseasesDiagnostic and Treatment Model；AiiT's Diversified Layout in the Big Health Sector，With Insurance Companies、Health Checkup Centers Achieve Large-Scale Collaboration。

Amid the achievements made by numerous leading enterprises，More Explorershas gradually begunEnter ImagingAI Sector。Unlike the initial wave of startups，CurrentMost market entrants are from Fujifilm、Companies with mature businesses, such as Kayi。Thismeans，Entire ImageAI Remains Full of Innovative Vitality。

New Year，There will be more head imaging scans.AI Companies Face a Critical Juncture as They Approach IPO，More capital will flow to these enterprises.。And they，or will be in2022Delivered a Satisfactory Commercialization Performance This Year。

Policy、With Dual Capital Support，ImagingAI has gradually become an indispensable part of smart hospital development.。However, problems have also arisen.，On the one hand,，An increasing number ofAI Enters Hospitals，How Should Physicians Manage？On the other hand，Single-Point FunctionalityAI Does Not Necessarily Reduce Physicians’ Workload，HealthcareHow Should AI Companies Design AI That Aligns with Clinical Diagnostic Workflows?？

AI Platforms Are the Widely Recognized Solution at This Stage，for integrating standalone functionalitiesAI，Enabling it to emulate physicians in providing comprehensive solutions。

SHUKUNas an example, this company is based onThe “Digital Doctor” product suite developed by the “Digital Human Technology Platform,”Combining and integrating existing artificial intelligence products，enabling the emergence of capabilities not found in standalone products,Provides a one-stop solution for radiology departments.。

In the past, SHUKUN’s coronary arteryCTA, One-Stop Stroke Solution, Liver MRand other productscontinuously achieving breakthroughs in specific scenarios, butTo Transcend This Era，AIIt is essential to break through the limitations of single departments and single modalities, starting from patients' physiological functions and adopting a holistic perspective to deliver more precise and convenient smart healthcare services.

Taking this as the entry point, SHUKUN has independently developed an AI-powered Digital Human technology platform to serve as the technical foundation for its Digital Doctor Platform, enablingIntegrating digital products for the “Digital Heart,” “Digital Brain,” “Digital Chest,” “Digital Abdomen,” and “Digital Musculoskeletal” systems to create a Digital Doctor portfolio platform comprising multiple “infrastructure” components. In the context of multimodal data, each infrastructure component must be capable of delivering comprehensive solutions.

Further segmented, SHUKUN's Digital Doctor portfolio platform is based on“HeartNon-contrast CT + Angiography”、“ChestPlain CT Scan”、“Head and NeckCT Plain Scan + Contrast-Enhanced Imaging”、“SkullCT Perfusion Imaging”、“LiverPlain MRI + Contrast-Enhanced MRI”Driven by imaging acquisition technologies, including cardiovascular/Cerebrovascular/Pulmonary Lesions/Hepatic Lesions/Musculoskeletal System, and Other Multi-Site Intelligent Imaging

As a hospital-level intelligent imaging platform, the Digital Doctor Suite can serve as a critical entry point for the diagnosis of major acute and chronic diseases. According to data collected by VCBeat, this platform is applicable to multiple clinical scenarios, including coronary heart disease, cerebral infarction, tumors, trauma, chest pain centers, stroke centers, and cardiology specialties. It has established a multidisciplinary diagnosis and treatment model supported by an imaging platform, ultimately forming a comprehensive, hospital-wide intelligent imaging solution.

With the most mature“DigitalBrain” as an example, this product connects SHUKUN’s previously matured products. Specifically, byNCCT、Head and NeckCTA、CTPWaitProduct integration, collectively forming“DigitalBrain“Family. After integration, SHUKUN can build diagnostic models based on multimodal data. The new models can not only meet individual needs of doctors but also provide comprehensive solutions.”，Provides a one-stop solution for the construction of stroke centers, which are currently undergoing vigorous development.。

To date, SHUKUN has spent nearlyOver the past four years, a digital human artificial intelligence technology platform has been developed, resulting in 37 products including Digital Heart, Digital Brain, Digital Chest, Digital Abdomen, and Digital Musculoskeletal systems. Although it is still some distance away from providing a complete solution, the Digital Doctor suite of platforms has already demonstrated significant value in medical institutions, as evidenced by the adoption of its single-organ products. After all, patients need only undergo a single scan of a specific organ to screen for a wide range of common conditions, which effectively reduces diagnostic and screening costs and leverages AI to realize the traditional Chinese medical principle of “superior physicians preventing disease before it arises.”

SHUKUN is not the only company leveraging a platform-based approach to simulate clinical solutions.，and provide a platformChemicalof the solutionThe multimodal diagnostic models proposed by AI companies are not limited to the aforementioned centers.。

In other words, under the combination of single-point products，ImagingAI's Scope of Impact Has Significantly Expanded。

VBInsightConducted an assessment of the market size for AI-based medical imaging diagnosis in China.，The institution is expected to2020Year－2025within the next decade，ImagingThe AI market size will grow at a compound annual growth rate147.7%the rapid growth rate of，and is expected to be in2030Annual Reach1665100 millionBeautyYuan。

Global Market Size of AI Medical Imaging: 2020–2030 (Source: CIC)

But beneath the platform, AI companies will be able to reach beyond just imaging diagnosis.