OrthoSpin receives FDA regulatory clearance for its G2 System
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.
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.