NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by NMPA recently, after the approval of Auxiliary triage software for coronary angiography image stenosis.
This product can be used for the display, processing, measurement and analysis of chest CT images. It can automatically identify and analyze pulmonary nodules of 4mm or above and their imaging characteristics.
This product is an artificial intelligence medical device software. Based on the basic framework of deep learning technology, it can carry out the automatic detection of pulmonary nodules with the premise of ensuring the accuracy of pulmonary nodules detection to meet clinical needs, improve the detection efficiency, and reduce the workload of doctors.
NMPA issued the Technical Guideline on AI-Aided Software on June 28, 2019, It lists the four focal considerations as follows:
During the technical review, the regulators will look at how the software is intended to be used, in what scenarios it is used and what core functions it has to ensure its safety and effectiveness.
They will place emphasis on how the software controls data quality and enables generalizations that allow an algorithm to be effective across a range of inputs and applications, as well as what clinical risks may arise. The risks arising from the software, according to the regulators, can lead to late or unnecessary diagnosis and treatment.
Companies should submit clinical data that supports their software. Regarding data, clinical institutions must meet the requirements for collecting, pre-processing and labeling data, and building datasets. For example, data masking and cleansing are required.
In addition, data used by the software for trial runs must be sourced from legitimate third-party databases to ensure the data is accurate, standardized and diverse.
For imported software, developers must provide the ethnic and epidemiological variations in the data. If they cannot ensure the software’s safety and effectiveness if used in China, they must conduct clinical trials in the country to prove its reliability within China.
As for algorithm design, regulators will look at algorithm selection, training and performance assessment as well as cybersecurity to ensure its interpretability.
The guideline also clarified that any algorithm-driven software updates would be considered major ones, which will require the regulators to re-assess the algorithm performance and clinical evaluation of the software to ensure its safety and effectiveness.
For in-depth analysis on Technical Guideline on AI-Aided Software, please see here (https://chinameddevice.com/china-cfda-ai-software-guideline/).
Considering that many manufacturers will go through the Innovation Pathway, NMPA is to publish the Technical Review Guideline on AI-Aided Software for Innovation Approval this year.
According to a consulting firm Marketing to China, the domestic market for AI medical devices reached 20 billion yuan ($2.95 billion) in 2018, with the aim of world’s largest hub for AI innovation by 2030. Accelerated efforts from NMPA will compel China to be the leader of AI medical applications.