On January 3, CFDA announced the announcement of the approval of the listing of pulmonary valved tubing products of Beijing Huanren Medical Technology Co., Ltd.
According to the announcement, the product consists of a near-end-end pipe and a telecentric end pipe, and the inner diameter of each part from the inflow end to the outflow end is the same (8-17 mm). The proximal cardiac tube adopts the bovine jugular vein tissue with the native trifoliate valve. The upper edge of the valve to the distal end of the valve adopts bovine pericardium tissue, which is treated by decellularization, removal of tissue immunogenicity and series of tissue anti-calcification treatment. Bionic structure design and sewing process. The product consists of a non-stented artificial biological pulmonary valve and an artificial large biological vessel for cardiac surgery, surgical reconstruction of the right ventricular outflow tract or replacement of previously implanted dysfunctional tubing to treat patients with right ventricular outflow tract malformation or lesions. .
CFDA said that the product was first approved for marketing, filling the gap in the field of high-end artificial biological heart valves for domestic medical devices, and bringing good news to the children with complex congenital heart disease.
It is reported that this is also the 2016, CFDA will be announced separately, special to fill the gap in domestic Medical Equipment / breaking the import monopoly of the ninth product.
The following are the details of domestic heavy medical equipment approved by the State Food and Drug Administration in 2016:
Orthopedic surgery navigation and positioning system approved for listing
Released on November 24, 2016
On November 14, 2016, the State Food and Drug Administration reviewed and approved the medical device registration of the orthopedic surgery navigation and positioning system (model: TiRobot) of Beijing Tianzhihang Medical Technology Co., Ltd.
The device consists of a host, robotic arm, surgical planning and control software, optical tracking system, master trolley and navigation and positioning kit for robotic assisted surgical instruments in open or percutaneous surgery in spinal surgery and traumatic orthopedics. Or the positioning of the implant.
The orthopedic surgery navigation and positioning system adopts 6-degree-of-freedom manipulator, compatible 2D and 3D medical imaging and other patented technologies. The performance indexes reach the international level of similar products, and are suitable for the use of traumatic orthopedics with cannulated screw internal fixation and spinal screw internal fixation. The patient can effectively ensure the accuracy of screw placement, shorten the operation time, reduce X-ray radiation damage, and reduce patient damage.
Prior to the launch of domestically produced products, such products were mainly imported from the United States and Germany.
enous catheter set,central venous catheter price,central venous catheter kit,central venous catheter triple lumen
Anesthesia Medical Co., Ltd. , https://www.medicaldiverse.com