OrthoSpin receives US FDA approval for smart, robotic external fixation system for orthopaedic treatments
OrthoSpin Ltd, a portfolio company of The Trendlines Group Ltd. (Trendlines), announced that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its smart, robotic external fixation system for orthopaedic treatments.
Today, the use of external fixation is a common treatment option for orthopaedic-related problems: bone lengthening, setting complex fractures, and correcting deformities. The two main challenges associated with these systems are patient compliance and lack of real-time feedback for the physician. External fixation requires the patient to make multiple manual adjustments every day. This requires significant patient training and involvement and can lead to errors. Many times, the patient does not fully or precisely comply with the mechanical adjustments, which results in less than optimal clinical outcomes.