In light of the State Council's "Deepening Standardization Work Reform Plan" and the General Administration of Quality Supervision, Inspection and Quarantine and the National Standards Commission's "Guiding Opinions on Cultivating and Developing Group Standards", DPM Company (comprising Zhuhai Dipu Medical Technology Co., Ltd. and Beijing Digital Precision Medical Technology Co., Ltd.) has recently collaborated with Guangdong Medical Device Quality Supervision and Inspection Institute to formulate two group standards: "Cold light source containing near-infrared excitation light for medical endoscope functional supply device" (hereinafter referred to as "Cold light source") and "Near infrared fluorescence camera system for medical endoscope functional supply device" (hereinafter referred to as "Camera system"). These standards have been developed in accordance with the "Group Standard Management Regulations" and are primarily being released on the national group standard information platform.
The current situation of tumors in China
Malignant tumors are the leading cause of mortality among Chinese residents, as evidenced by the latest Global Cancer Burden Data 2020. In 2020, an estimated 4.57 million new cases and 3 million deaths from cancer will be reported nationwide, highlighting a substantial patient base.
Currently, surgical resection remains the primary treatment modality for primary tumors. Typically, preoperative imaging techniques such as CT, MRI, and ultrasound are utilized to determine the location of the tumor. During the operation, the surgeon relies on observation and palpation to determine the extent of surgical resection. Tumor localization is heavily dependent on the surgeon's experience, often resulting in only a rough approximation of the tumor boundary. Despite expanding the resection scope, there is still a risk of missing cancerous foci, leading to tumor recurrence and metastasis in 8% to 50% of patients post-surgery.
Therefore, surgical oncology urgently needs an intraoperative imaging device with high sensitivity and specific real-time imaging of tumor tissue cells to quickly define the tumor boundary and clarify whether the tumor is completely resected.
Market oriented near-infrared fluorescence molecular imaging technology
Traditional preoperative imaging diagnostic equipment primarily serves the imaging department or radiology department of various hospitals, offering image-based disease diagnosis and prognostic solutions. In contrast, emerging near-infrared fluorescence molecular imaging technology caters to a diverse range of surgeons, providing precise intraoperative localization of diseases for various surgical operating rooms in hospitals. This technology significantly enhances the therapeutic efficacy of surgeries and contributes significantly to improving patient outcomes.
To further promote and standardize the development of near-infrared fluorescence imaging technology, break foreign high-end medical device field monopolies, and increase benefits for both doctors and patients, the drafting unit has jointly formulated two group standards, which are being released for the first time in China.
Group standard release promotes personalized and precise development
These two group standards have been formulated with original and independent intellectual property rights, encompassing near-infrared fluorescence imaging technical indexes and test methods. This development is supported by the "near-infrared fluorescence imaging intraoperative navigation system" of the Digital Diagnostic and Treatment Equipment R&D Special Project of the Ministry of Science and Technology of the People's Republic of China, as well as the research and development efforts of the National Innovative Medical Devices and the Beijing Municipal Innovative Medical Devices. The release of these two group standards addresses the existing gaps in domestic standards within the field of fluorescence endoscopy, facilitating further research, discussion, and policy standardization. These standards will serve as a valuable reference for the establishment of industry standards, ultimately promoting the advancement of individualized precision medicine.
DPM has strong capabilities and a long way to go
DPM, a national high-tech enterprise, has been granted one American invention patent and numerous national invention patents to date. The related products and technologies have garnered significant recognition, including the Second Prize of the National Technical Invention Award, the Second Prize of the National Science and Technology Progress Award, the Gold Prize at the Geneva International Invention Fair, the Gold Prize at the International Invention Exhibition, the Gold Prize at both the 21st and 23rd National Invention Exhibitions, the First Prize for China Medical Devices Innovation and Entrepreneurship by the Ministry of Science and Technology of the People's Republic of China, the National Green Channel for Special Approval of Innovative Medical Devices, the Red Star of Design Award in China, and the First Prize for the Transformation of Scientific and Technological Achievements of CAS. These accolades reflect DPM's commitment to excellence and innovation in the field of medical technology.
Looking towards the future, DPM will persistently adhere to the principle of "precision as our purpose, innovation as our goal, and talent as our capital." We will continue to advance with precision, innovation, openness, and a win-win attitude. By integrating innovative resources from all sectors, we aim to promote the application of molecular imaging technology in the field of human healthcare and development.
On the journey towards cancer prevention and treatment, DPM stands by your side, ensuring a healthy future for you.
