OrthoSpin Announces Its G2 System Received FDA Regulatory Clearance

Xenter, Inc. Appoints 4 Industry Leaders to Board of Directors; Closes $12M Series A

Xenter’s first product, which the company will announce shortly, is a medical device that not only combines the function of multiple existing devices but will also revolutionize the field of interventional medicine by producing valuable Physical Intelligence™ data and enabling advanced Artificial Intelligence solutions, leading to improved patient outcomes while reducing the cost, complexity and invasiveness of cardiac procedures.

Indivumed Partners with Oslo University Hospital to Advance Cancer Research

By scanning high-resolution images of haematoxylin and eosin-stained tumor section slides for all IndivuType cases, Indivumed will be able to leverage an entirely new dimension of data in the coming months.

Harold Hill Joins NeuX Technologies as Director of Corporate Accounts

Harold Hill is a retired Special Forces Medic, serving 26 years, and led the medical department for a Special Missions Unit within the United States Special Operations Command

January 25, 2021

OrthoSpin Ltd. (“OrthoSpin”), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its second generation, robotic, digitally-enabled external fixation system for orthopedic treatments – G2 System.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities. Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges. Currently, effective treatment necessitates that patients manually adjust fixation devices daily, requiring complicated patient training. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.

The Company has completed initial clinical cases in the U.S. and Israel with the FDA-cleared OrthoSpin Generation 1 system which makes pre-programmed adjustments automatically without the need for patient involvement. Integrated software enables physicians to chart patient progress and, when required, immediately adjust treatment programs. The second-generation system represents a technological leap forward as it is more user friendly, covers all strut range sizes, and is lighter by 20%.

“We are very excited to launch the Generation 2 OrthoSpin system,” said Dr Assaf Dekel, Active Chairman of OrthoSpin. “We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation.”

Future applications, such as the ability to follow and modify treatment plans via smart phones and cloud-based AI algorithms treatment plans based on computerized historical data, have the potential to play an increasingly prominent role in medicine and healthcare.

The OrthoSpin G2 system is approved in Israel and-cleared for use in USA and can be used with the DePuy Synthes MAXFRAME™ Multi-Axial Correction System.

 

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine

Related Articles