StrongLink Intelligence®: China's First AI-Assisted Therapeutic Software Granted Fast-Track Approval, Pioneering the Future of Medical AI

April 24, 2021, Union Strong^®The first blockbuster product, the Intracranial Aneurysm Surgical Planning Software, has been approved for a Class III registration certificate through the innovative approval green channel. This is the first AI-assisted treatment software in China to enter the National Medical Products Administration’s green channel process.

This softwareIt is an integrated solution that applies AI technology to both diagnosis and treatment, marking the evolution of medical AI from initial screening and intervention to core stages such as diagnosis and therapy. This breakthrough will set a benchmark for medical AI companies, signaling that more enterprises will expand their use of AI technology from screening and intervention to diagnosis, treatment, follow-up, and other areas in the future.

Meanwhile, the product’s approval via the green channel for innovative review of Class III medical device registration signifies that Union Strong^®The world’s first independently developed product has gained recognition from the National Medical Products Administration and clinical experts due to its innovation and urgent clinical need, and is expected to fill an international gap.

Union Strong^®states: “Intracranial Aneurysm Surgical Planning Software (hereinafter referred to as UKnow^®) As a project for the transformation of scientific research achievements under the 13th Five-Year Plan, led by Professor Gu Yuxiang’s team from Huashan Hospital Affiliated to Fudan University, Professor Zhang Hongqi’s team from Xuanwu Hospital of Capital Medical University, and Union Strong^®"The R&D team has completed the development after several years of research. It is a genuine Chinese original innovation and a global first, having already obtained multiple domestic and international invention patent authorizations."

Union Strong (Beijing) Tech. Co. Ltd. (hereinafter referred to as "Union Strong")^®) was established in September 2016, focusing on cerebrovascular diseases and committed to achieving intelligent diagnosis and treatment of cerebrovascular diseases through digital technology. Currently, Union Strong^®It has become China’s largest intelligent diagnosis and treatment platform for stroke, working in close collaboration with the nation’s top neurological clinical centers—including Xuanwu Hospital, Tiantan Hospital, Changhai Hospital, and Huashan Hospital—to provide stroke patients with intelligent, full-course services spanning screening, diagnosis, treatment, and follow-up.

According to reports, Union Strong^®Union Strong has developed a range of intelligent assistive products that cover the entire disease course of various hemorrhagic and ischemic stroke conditions.^®Chairman Qin Lan stated, “We address critical pain points in treatment and extend our solutions forward to diagnosis and screening, and backward to patient follow-up, ultimately achieving intelligent assisted diagnosis and treatment across the entire disease course. Among these, the intracranial aneurysm surgical planning software is developed by Union Strong”^®"First blockbuster product."

Clinical experts at the review panel evaluated this software as a disruptive product. The experts stated, “The intracranial aneurysm surgical planning software will transform the process by which physicians learn neurointerventional procedures, overturning the traditional master-apprentice model. Because the application of this software significantly reduces the difficulty of neurointerventional surgery, beginners are expected to perform surgeries directly with the assistance of this product.”

It is evident that intracranial aneurysm surgical planning software can significantly reduce the learning curve and operational threshold for neurointerventional procedures, meaning that an increasing number of physicians will be able to utilize UKnow^®Conducting neurointerventional surgeries independently with assistance also means that doctors in primary hospitals will acquire the skills to perform such procedures, thereby treating more patients with intracranial aneurysms.

On the other hand, as this product becomes more widely adopted, it will also help popularize neurointerventional procedures, improve the overall cure rate for cerebrovascular diseases in China, and protect the health of more people.

For renowned experts at top-tier hospitals, UKnow^®It can help improve the precision of diagnosis and surgery, simplify complex procedures, and facilitate the exploration of more challenging neurointerventional surgeries.

Meanwhile, UKnow^®Significantly reducing surgical time decreases clinicians’ radiation exposure, substantially lowers radiation doses for both physicians and patients, helps reduce postoperative complications in patients, and safeguards the health of both medical staff and patients. Furthermore, shorter surgical times enable tertiary hospitals to improve bed turnover rates, thereby increasing revenue, reducing costs, and allowing more patients with intracranial aneurysms to be treated.

For primary care hospitals, this software empowers primary care physicians, enabling them to use UKnow^®Independently perform neurointerventional procedures with assistance, providing timely treatment for patients with intracranial aneurysms, thereby enhancing diagnostic and therapeutic capabilities while increasing revenue for primary-care hospitals.

By empowering hospitals and physicians, the ultimate beneficiaries are inevitably the patients. First, an increase in the number of physicians qualified to perform neurointerventional procedures will meet the treatment needs of a large patient population. Second, with the widespread adoption of neurointerventional techniques, patients suffering from vascular rupture can seek treatment at the nearest hospital without concern about whether primary care facilities possess the necessary therapeutic capabilities. Third, supported by precise diagnosis and targeted therapy, surgical procedures become shorter, safer, and associated with fewer complications.

Overall, intracranial aneurysm surgical planning software can significantly reduce operative time, lower radiation exposure for both surgeons and patients, shorten the learning curve for physicians, and enhance diagnostic accuracy and surgical proficiency. Furthermore, this product will empower physicians at primary-care hospitals, improve the overall cure rate for cerebrovascular diseases, and optimize patient outcomes.

Intracranial Aneurysm Surgical Planning Software is designed to assist physicians in analyzing the three-dimensional morphology of intracranial aneurysms and performing automated surgical planning, ultimately facilitating the more effective execution of neurointerventional procedures.

Data indicate that China has nearly 100 million patients with intracranial aneurysms, and there are 5 million new stroke cases each year, while the number of experienced neurointerventional surgeons is significantly insufficient. It is evident that limited medical resources struggle to meet the diagnostic and treatment needs of all patients. However, once a stroke occurs, it poses severe consequences; according to data from The Lancet, stroke was the leading cause of death in China from 1990 to 2017, with an overall mortality and disability rate exceeding 60%.

Taking intracranial aneurysms as an example, the prevalence of this condition is approximately 2–3% in foreign countries, whereas it reaches as high as 7% among the adult population in China. For patients, intracranial aneurysms are asymptomatic and thus undetected unless they rupture and cause hemorrhage; however, once ruptured, the mortality rate is as high as one-third, and exceeds one-half in cases of rebleeding, rightly earning them the reputation of being a “ticking time bomb” within the brain.

Therefore, neurointerventional therapy for cerebrovascular diseases such as intracranial aneurysms has gained favor among physicians and patients due to its minimally invasive nature, safety, and efficacy, and is being progressively adopted. However, neurointerventional procedures are technically demanding; it takes 1–2 years of training and performance of hundreds of cases for a novice to become a qualified neurointerventionalist. This indicates that the learning curve is steep and the training period is prolonged, particularly for grassroots physicians, who rarely have opportunities to practice these procedures.

On the other hand, unlike traditional open surgery, neurointerventional procedures do not allow for direct visualization of the anatomical features of the lesion or the operative maneuvers. Beginners must reconstruct a three-dimensional (3D) map of the cerebral vasculature from complex two-dimensional (2D) angiographic images, identify the lesion, mentally conceptualize the optimal 3D shape of the microcatheter for treatment, and then proceed with microcatheter shaping. However, due to the intricate 3D architecture of cerebral vessels and the highly indirect nature of the intervention, beginners require extensive training to gradually adapt, which is a prolonged process.

Qin Lan stated, “Through our clinical practice observations over nearly two decades, as well as in-depth exchanges with clinical experts, we have found that the widely recognized challenges in neurointerventional surgery are microcatheter shaping and the selection of consumable models. Once these two major challenges are addressed, the difficulty of the surgery will be significantly reduced. Therefore, Union Strong^®UKnow was developed to address the aforementioned critical pain points in treatment.^®Intracranial Aneurysm Surgical Planning Software.

This software integrates patented algorithms, such as surgical simulation, to achieve microcatheter shaping through computer-aided methods. Specifically, it performs 3D reconstruction of cerebrovascular images and automatic morphological analysis of aneurysms and parent arteries. By combining these with path simulation of the microcatheter’s helical advancement, the system directly generates a shaping plan, providing the optimal solution for the 3D shape of the microcatheter tip. Furthermore, it recommends specific shaping pin protocols based on the recoil characteristics of microcatheters from different manufacturers. Through UKnow^®Assisted by the system, clinicians can visually observe a 3D visualization of the cerebral vasculature, accurately identify the lesion site, and shape the microcatheter according to the optimal solution provided by the software.

Next Step, UKnow^®It also determines the most suitable consumables for patients based on the three-dimensional morphology of cerebral blood vessels, addressing the second major pain point in neurointerventional surgery. When both pain points are resolved, the difficulty of neurointerventional procedures will be significantly reduced, enabling beginners to quickly get up to speed and perform surgeries independently. Furthermore, leveraging its precise 3D morphological analysis of lesion sites and rapid, accurate microcatheter shaping capabilities, this software can reduce neurointerventional surgery time by approximately 70%.

In the future, Union Strong^®Further development of surgical robots will be pursued to provide more robust assistance to physicians during procedures. In addition, Union Strong^®We will continue to develop new features and expand coverage to additional stroke subtypes, providing physicians with intelligent assistance across the entire disease course, including disease screening, automated diagnosis, treatment support, and patient follow-up.