Shukun Technology Secures Both Global Liver MRI NMPA Class III Certificates, Paving the Way for IPO

On July 25, 2024, the official website of the National Medical Products Administration (NMPA) announced that the MR Image-Assisted Evaluation Software for Focal Liver Lesions, developed by SHUKUN, had officially received NMPA Class III medical device registration certification.

This product leverages deep learning technology to perform segmentation and reconstruction of the liver, liver segments, blood vessels, and lesions, as well as automatic naming of liver segments and vessels, and analysis of focal liver lesions. This is the second Class III medical device certification for liver MRI AI obtained by SHUKUN, and also the second such certification in the entire industry. Combined with the first liver MRI AI Class III certification that SHUKUN received in November 2023, SHUKUN has now secured both of the only two NMPA Class III certifications available in the field of liver MRI.

According to World Health Organization statistics, liver cancer is the sixth most common cancer globally, with over 900,000 new cases annually, and China accounts for half of the world’s liver cancer patients.

Liver cancer not only has a high mortality rate but is also extremely difficult to detect in its early stages; over 90% of patients are diagnosed at an advanced stage, resulting in a five-year survival rate of only 12%.

Liver Cancer Strikes Aggressively, Yet Diagnosis Remains Extremely Challenging.

● Difficulty in Sequence Registration: A single liver imaging examination often generates over 1,000 images with varying slice thicknesses and liver positions, requiring physicians to spend considerable time comparing and reviewing scans across different sequences.
● Difficulties in Imaging Diagnosis: The liver is a compliant organ that moves with respiration and body motion; varying imaging slice thicknesses complicate lesion registration, making differential diagnosis challenging.
● Difficulty in Precise Assessment: Liver cancer can be treated through various modalities, including surgery, interventional therapy, and targeted therapy. Preoperative assessment of the future liver remnant ratio and evaluation of the efficacy of interventional or targeted therapies require radiologists to precisely quantify the proportion of enhancement within lesions, thereby providing accurate decision support for clinical practice.

SHUKUN integrates artificial intelligence with the diagnosis of focal liver lesions, pioneering a proprietary smart liver cancer solution.

● Sequence Registration Is No Longer Difficult: Full-sequence automatic recognition technology, registering 12 sequences, enabling ultra-fast intelligent image interpretation with personalized arrangement and automatic layout within 1 second.
● Imaging Diagnosis Is No Longer Difficult: The world's first flexible registration digital subtraction technology can clearly enhance the enhancement characteristics of lesions in each phase, providing a strong basis for accurate diagnosis.
● Precise Assessment Made Easy: Features quantitative assessment capabilities, automatically and intelligently measuring quantitative lesion information to empower precision therapy.

The approval of SHUKUN’s second Class III NMPA certificate for liver MRI AI marks a milestone, demonstrating that SHUKUN’s proprietary artificial intelligence technology can assist physicians in enhancing diagnostic and therapeutic efficiency and precision for high-risk liver populations across precise screening, early diagnosis, differential diagnosis, and treatment support. Furthermore, it empowers junior doctors with the expertise of senior specialists, truly achieving standardization and homogenization of medical care quality, thereby benefiting a broad population of liver disease patients.