Saturday, September 23, 2023
Saturday, September 23, 2023

MicroPort Navibot Receives 510(K) Clearance for SkyWalker™, the Company’s First Robot-Assisted Platform for Orthopedic ApplicationsI

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker™ System, the company’s first robot-assisted platform for orthopedic applications. SkyWalker will initially offer a robotically assisted total knee replacement solution that is compatible with the Evolution® Medial-Pivot total knee system.

Designed based on clinical needs, MicroPort NaviBot has built a full technology research facility that has medical industry design capability, and benefits from core technological advantages of having a self-developed, high-dexterity, and lightweight mechanical arm combined with intelligent planning and navigation algorithms. SkyWalker has the technical advantages of precise operation and efficient coordination, while prioritizing safety. Prior to the actual surgery, the planning system assists surgeons in formulating personalized patient implant plans based on preoperative CT scan anatomical data as well as specific implant data. During surgery, based on actual patient alignment and anatomy, the SkyWalker system facilitates precise implant positioning to achieve the desired kinematics specific to the patient. SkyWalker then allows the surgeon to quickly proceed to resection using a high-dexterity and lightweight mechanical arm resulting in improved precision, accuracy, and efficiency.

SkyWalker is capable of providing the surgeon with information that can help to achieve the desired joint line reconstruction while providing data to optimally balance soft tissues. MicroPort Navibot is planning to develop other orthopedic applications in the near future, in conjunction with MicroPort Orthopedics, for a more comprehensive orthopedic offering.

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OTHER NEWS

FDA Grants Fast Track Designation to 9MW3011

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MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury

Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures.

Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

Annalise.ai has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program.

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