The committee meeting of the China Artificial Intelligence (AI) Medical Device Innovation Cooperation Platform was held on September 21, 2022.
Focusing on bio-digital integration, experts and industry leaders discussed AI technology ranging from brain-computer interface, wearable devices, bioartificial organs innovative application model of medical devices, evaluation tools for the safety and effectiveness of software and hardware framework, interactive feedback, processing algorithms to the personalized diagnosis and treatment.
Guidelines specify clinical evaluation of deep learning medical devices, identification, and assessment of cybersecurity vulnerabilities, technical requirements, and test methods in 5G-based ultrasonic diagnostic systems, robotic intervention diagnostics and treatment systems, robot-assisted laparoscopic surgery, and cervical cytopathological image standard system. Guideline listed below will be released in 2023:
- Clinical evaluation of deep learning medical devices
- Method for identification and assessment of cybersecurity vulnerabilities in medical devices
- Technical requirements and test methods of 5G-based ultrasonic diagnostic system
- Technical requirements and test methods of 5G-based robotic interventional diagnosis and treatment system
- Technical requirements and test methods for 5G-based remote robot-assisted surgery: laparoscopic surgical robot
- Technical requirements and test methods for 5G-based telemedicine private network
- Cervical cytopathological image standard database data standard system
- Medical artificial intelligence technology terms
The China AI Medical Device Innovation Cooperation Platform has 17 expert groups, two more new groups were added in 2022: Bio-digital integration for diagnostic and treatment application technical research, and digital therapy. I listed total 19 groups below for your reference.
- Technical regulations
- Data governance
- Evaluation of database establishment
- Cyber security
- Standardized Research
- Evaluation Technology Research
- Clinical evaluation
- Real world data applications
- Talent development
- International exchange
- Research on Medical Data Application Technology
- Medical AI terminology normalization
- Intelligent medical device core components
- In-depth research on high-end medical equipment
- Research on the new generation of wireless diagnosis and treatment application technology
- Research on the intelligent medical device industry development
- Evaluation on AI medical imaging diagnosis and treatment technology
- Bio-digital integration for diagnostic and treatment application technical research (new)
- Digital therapy (new)
If you have any challenge on clinical evaluation, technical requirements, or testing methods of AI innovative medical devices, feel free to comment below or email me for a chat.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------