A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

OrthoSpin Announces Its G2 System Received FDA Regulatory Clearance

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.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy