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On August 31, the official website of the State Food and Drug Administration released the information on the approval of three innovative medical device products, namely the innovative product "Medical Adhesive" produced by Hangzhou Yahui Biotechnology Co.
"Medical Adhesives", "Magnetic Resonance Imaging Systems", "Chronic Glaucoma-like Optic Neuropathy Fundus Image-Assisted Diagnosis Software"
At present, the number of innovative drugs and devices approved by the State Food and Drug Administration has reached 176
Medical adhesive is the first adhesive medical device
During parenchymal resection, this product can be used for auxiliary sealing at the site of visceral pleura after closing the wound by conventional methods such as standard suture/nailing, and when the visceral pleura is still leaked by immersion air leakage test
The "magnetic resonance imaging system" consists
Suitable for clinical MRI diagnosis in patients weighing more than 20 kg
The core technologies are full-body clinical 5.
"Chronic glaucoma-like optic neuropathy fundus image assisted diagnosis software" consists of a server, a management platform and a clinical client, including three functional modules
It provides a quality control method that can automatically identify common fundus image quality problems in clinical practice, such as non-fundus images, large-area fouling and refractive interstitial opacity, effectively improving the accuracy and confidence of auxiliary diagnosis, and is expected to solve the problem
Provides a quality control method to effectively improve the accuracy and confidence of auxiliary diagnosis.