A medical device enters the innovation channel

October 18, 2024  Source: drugdu 72

"/Recently, the Shanghai Medical Products Administration announced that in accordance with the requirements of the "Special Review Procedure for Class II Innovative Medical Devices in Shanghai", the Shanghai Medical Products Administration has organized relevant experts to review the special review application for Class II innovative medical devices in the city, and intends to agree to allow Shanghai Futuo Zhida Medical Technology Co., Ltd. (hereinafter referred to as "Futuo Zhida") to enter the special review procedure for its disposable pulmonary nodule three-dimensional identification positioning marker.

Developing innovative technologies with AR navigation systems
Founded in 2018, Futo Zhida is a subsidiary of Fosun Pharma, focusing on innovative medical devices and surgical development. Its team has rich experience and a global perspective in the development of image navigation algorithms, intervention consumables design, and production.

According to the Chinese Journal of Tuberculosis and Respiratory Sciences, the incidence rate and mortality of lung cancer rank first among malignant tumors in China. At present, the 5-year survival rate of lung cancer in China is 19.7%, and the 5-year survival rate of patients with stage I lung cancer can reach 77%~92%. Early diagnosis and treatment of lung cancer is the key to improve the 5-year survival rate of lung cancer and improve the prognosis of patients.

However, early detection of lung cancer is difficult, and patients almost do not feel any abnormal symptoms in the early stages, which leads to most lung cancer patients entering the middle and late stages when symptoms appear for diagnosis and treatment.

In response to the current situation, Futuo Zhida has targeted the AR navigation system and developed innovative minimally invasive surgical procedures, creating an integrated solution for early diagnosis and treatment of tumors and pulmonary nodules.

Its core products include: the world's first monocular visual augmented reality navigation system, pulmonary surgery labeling system, and minimally invasive early pulmonary nodule puncture resection system. Futuo Zhida has established multidimensional competitive barriers covering intellectual property, core algorithms, and production processes through completely independent research and development and production, and has built a global product competitiveness that combines software and hardware.

The precise and portable AR navigation puncture positioning system of Futuo Zhida is the world's first lung percutaneous puncture navigation system. Combining computer vision monocular tracking technology and AR display technology, it optimizes the positioning process while achieving precise positioning, giving more grassroots hospitals the opportunity to carry out precise thoracoscopic surgery.

The disposable three-dimensional identification and positioning marker for pulmonary nodules that has entered the special review process is also one of the innovative achievements of Futuo Zhida in the field of minimally invasive diagnosis and treatment of pulmonary nodules. It was officially approved for market on August 1st and can provide safe and effective precision minimally invasive treatment for lung cancer patients.

And this year, Futuo Zhida also has a heavyweight product - a lung specific image processing software, which was approved for sale in August. The software can display and automatically process CT images of patients' lungs, achieving intelligent 3D reconstruction. By visually displaying key medical information such as the patient's organs and lesion location, the efficiency, accuracy, and reliability of clinical diagnosis can be greatly improved.

In addition, at the SIO 2024 Scientific Conference, Futo Zhida also showcased its world's first early treatment plan for lung tumors, including an augmented reality navigation system based on monocular vision navigation, a rapid preoperative/intraoperative pulmonary nodule localization system, and a percutaneous pulmonary nodule diagnosis and resection system. As the progress continues to advance, there will be more innovative products launched by Futuo Zhida in the future.

Conclusion
For the current focus on the field of lung cancer, the ideal of Futuo Zhida is that in the near future, there will be no need to wait for small lung nodules to become larger and malignant before implementing surgical intervention. Only one day surgery is needed, guided by imaging and AR glasses, through surface puncture, opening a small incision of 2-3mm, and completely removing nodules of 8mm or below in the body, completely removing the "ticking time bomb" in the body.

Source: https://news.yaozh.com/archive/44376.html

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