led by universities and clinicians, this software has been approved for class iii medical device registration
2024-09-07
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on september 5, a reporter from the paper learned from fudan university that the research achievement "intracranial aneurysm magnetic resonance angiography image-assisted detection software (aineurysm)" developed and successfully transformed by the team of professor geng daoying, executive deputy director of the institute of biomedical engineering technology of fudan university institute of engineering and applied technology (hereinafter referred to as "itri") and academic leader of radiology of huashan hospital affiliated to fudan university, has been officially approved by the china national medical products administration (nmpa) for class iii medical device registration.
this is the first registration certificate for a class iii medical device in china for intracranial aneurysm magnetic resonance ai research and development led by a university and clinical doctors. the implementation and transformation of this achievement also marks a major original breakthrough in fudan university's full-chain innovation exploration of "integration of medicine and engineering".
aineurysm interface. image provided by the research team
driven by clinical pain points, full-chain innovation from 0 to 1 was achieved in 6 years
"the image-assisted detection software for intracranial aneurysm magnetic resonance angiography has increased the aneurysm detection rate by 10%, and the diagnostic efficiency has increased from 82% to 94%. the film reading time for each case has been shortened by 60%. not only has the diagnostic efficiency been greatly improved, but the sensitivity and specificity are also higher than those of the doctor group. in addition, the software's operating interface is simple and friendly, and conforms to the doctor's existing workflow. it only takes doctors 3 minutes to complete the training and get started quickly." geng daoying told the reporter from the paper that the effectiveness of "ai+doctor" is far greater than that of a single doctor, but ai technology itself lacks medical warmth. therefore, medical clinical practice in the future cannot rely purely on ai. doctors must combine ai to achieve interactive synergy.
according to geng daoying's team, intracranial aneurysm is a protrusion formed by abnormal bulging of the arterial wall, which is like a "time bomb" in the human brain. once ruptured, acute subarachnoid hemorrhage will occur, and even rupture into the brain substance and ventricular system. it has the "three highs" characteristics of high morbidity, high disability rate, and high mortality rate. clinical diagnosis and treatment are faced with the "three early" needs of early examination, early diagnosis, and early treatment. in the past, due to the limitations of imaging equipment and the level of imaging doctors, there were a large number of misdiagnoses and missed diagnoses of major diseases in clinical practice.
how to reduce the probability of misdiagnosis and missed diagnosis and improve the diagnosis and treatment efficiency of intracranial aneurysms? driven by doctors' discovery of problems and clinical needs, a six-year "from 0 to 1" scientific research breakthrough began.
according to geng daoying, a medical and engineering team has been formed, including management experts, doctors, and engineering experts. the doctor team annotates images, the model team develops algorithms, and the software engineering team achieves interface friendliness... each link of research and development is closely linked, and members have repeatedly run-in to break through the disciplinary barriers of "different trades are like different mountains". the product has also undergone repeated supplementary materials and model optimization. after coming out of the laboratory, the product will continue to go through the transformation of results, testing by the shanghai testing institute, pre-registration national multi-center clinical trials, submission to the national medical device review center for review, and on-site system verification by the shanghai medical device approval center.
from the project initiation in 2019 to the completion of clinical trials in july 2023, and then to the acquisition of the class iii registration certificate in 2024, after 6 years of hard work, the team has finally completed the entire chain of industry-university-research-application innovation from 0 to 1, and mastered the independently developed core artificial intelligence algorithm. as an artificial intelligence product, the intracranial aneurysm mri image-assisted detection software can assist doctors in making accurate imaging decisions, display, process, measure and analyze cranial mri images, and assist in the detection of intracranial aneurysms of 3mm and above. it can prompt patients with suspected intracranial aneurysms, help doctors conduct effective detection, and quantitatively analyze the aneurysm area and give relevant suggestions.
"i hope that with the promotion and clinical application of the product, the ability of imaging doctors in different regions to identify aneurysms will be improved, the medical burden on the country, society and families will be reduced, the difference in film reading levels among doctors in different regions and hospitals will be narrowed, and more patients will benefit." this is geng daoying's expectation for the future.
fudan university institute of engineering and applied technology. image source: fudan university
the “medical-engineering integration” platform supports the emergence of breakthrough results
starting from clinical needs, a medical-engineering team was formed to solve clinical problems with advanced technologies and finally apply them in clinical practice. with the implementation of the intracranial aneurysm mri image-assisted detection software, the intelligent imaging medical-engineering team completed a closed loop of the r&d process. in geng daoying's view, this is inseparable from the support of the "medical-engineering integration" platform of fudan university's institute of industrial technology.
"'stem cells' are called universal cells, which have the ability to differentiate in multiple directions and divide and proliferate indefinitely. itri wants to cultivate top innovative talents like 'stem cells'. we hope to give students the right and ability to grow like stem cells." gan zhongxue, deputy dean of itri of fudan university, told reporters that in recent years, fudan university has continued to lay out the construction of new engineering disciplines and established the institute of engineering and applied technology in 2017. in order to promote the intersection of medical and engineering disciplines and enhance the driving force of innovation, itri launched the "medical and engineering integration" project as soon as it was established. now itri has become an important platform that brings together clinical doctors, scientific and engineering researchers, and links scientific research experts and industrial resources in the field of medical devices.
zhang rongjun, deputy director of the industrial technology research institute, introduced that in the process of exploring the construction of the "integration of medicine and engineering" platform, the industrial technology research institute has established a series of project organization forms: implementing a dual responsibility system between affiliated hospitals and science and engineering colleges and departments, with the hospital as the first person in charge, effectively mobilizing the enthusiasm of clinical doctors and scientific researchers to participate in the project; doctors set the questions and scientific researchers take charge to ensure that the project is always closely centered on clinical needs; establishing a long-term mechanism to strengthen communication between science and engineering colleges and departments and affiliated hospitals... all institutional innovations point to the same goal - to stimulate the potential of scientific research, joint research and results transformation of the school and affiliated hospitals around the integration of medicine and engineering.
"now, the clinical doctors and science and engineering researchers who apply for medical-engineering projects every year cover almost all the affiliated hospitals and science and engineering departments of the school. the research directions include innovative medical instruments and equipment, in vitro testing, advanced medical materials, medical robots and other fields." zhang rongjun introduced that the intraoperative optical imaging equipment used to guide medical cosmetic injection fillings, the femtosecond stimulated raman pathology microscope for rapid endoscopic detection of gastric cancer, the development of intelligent auxiliary diagnosis software for stroke, the research on diabetic foot gait recognition technology based on shear force characterization, and the application research of the alveolar bone functional adaptive reconstruction model for orthodontic tooth movement evaluation... today, a batch of transformable innovative medical devices and new technologies that can be used in clinical practice are emerging one after another.
the paper reporter ju wentao
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