OrthoSpin Gains FDA Clearance for Robotic ExFix System

By Julie A. Vetalice

OrthoSpin Gains FDA Clearance for Robotic ExFix System

OrthoSpin received FDA 510(k) clearance to market its smart robotic external fixation system for orthopedic treatments.

The system addresses patient compliance and lack of real-time feedback for the physician. The robotic struts, which make automatic programmed adjustments, eliminate the need for manual involvement and improve patient compliance. The system monitors biomechanical parameters, and in the future will be able to automatically send real-time updates to physicians to track patient progress. This allows fine-tuning of the treatment regimen, including a personalized treatment plan for each patient.

The device was developed with investment support led by Johnson & Johnson Innovation - JJDC.

 

Source: OrthoSpin

Product Labels: External Fixation

Tags: 510(k) Clearance, Regulatory