Jiangsu Shitong Bio-Tech Co, a high-tech enterprise specializing in miniature diagnostic robots, recently obtained a Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA) for its self-developed "Capsule Endoscopy System for Small Intestine Imaging". The product is expected to enter mass production by the end of this year.
Established in 2019 as a talent-driven enterprise in the Nantong National High-tech Industrial Development Zone (NHIZ), Shitong Bio-Tech has achieved rapid growth through six years of development.
The newly approved system is a medical device used for capturing and viewing images of the small intestine. During the use of the "capsule", it employs Shitong's panoramic reconstruction technology to assist doctors in achieving panoramic image review, providing precise, visual, and quantifiable diagnostic support.
Class III medical devices, which are often implanted to sustain life or present critical health risks, undergo the strictest safety and efficacy evaluations. In China, registration certificates are exclusively issued by the NMPA.
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