Medical network - October 21 October, domestic big progress again for examination and approval of innovative medical devices. A zhejiang machinery companies one to break the monopoly to import the domestic innovative PET/CT are allowed to register, Shanghai three machinery enterprise three innovative products to passage into special examination and approval.
Domestic innovative PET/CT were allowed to register
According to the website of state administration of drug safety, recently, administration after examination and approval of the MingFeng medical systems co., LTD., production of "positron emission and X-ray computed tomography (ct) imaging device".
The product by the scanning plane (including PET frame, PET detector, data acquisition system and computed tomography (CT) frame, X-ray tube assembly, high voltage generator, CT detector, limited beam splitter), diagnosis bed, power cabinets, computer image processing system and a control box.
This product combines X-ray computed tomography (CT) and positron emission computed tomography (PET) system, provide the physiological and anatomic information of registration and fusion. The product gamma photon localization precision, digital signal processing and sampling method is advanced, the generated image at the same time, including the functions of human organs and tissues or anatomical information, information can be used for tumor, brain diseases, and cardiovascular disease diagnosis, treatment and curative effect evaluation and so on.
It is reported, by zhejiang MingFeng medical research and development of the PET/CT equipment listed, will present situation mainly imports of similar products in China, also marks the Chinese large-scale high-end medical imaging equipment development and production level to a new level.
Shanghai three machinery enterprise products fitting into the fast channel
On October 18, drug safety administration of medical devices technical evaluation center "innovation medical instrument special approval to apply for review the results of the public no. 9 (2016), agreed to three innovative medical devices for project into the special examination and approval procedures.
Are:
1, the product name: dynamic glucose monitoring system
Applicant: Shanghai yu technology co., LTD
2, the product name: closure system
Applicant: Shanghai medical technology co., LTD
More than 3, the product name: renal artery electrode radiofrequency ablation catheter and multi-channel renal artery radiofrequency ablation instrument
Applicant: Shanghai anstone medical technology co., LTD
All of the above three products from Shanghai medical instrument companies, Shanghai is the big winner of the October innovation YiXie. |
