Gauthier Biomedical Gains FDA Clearance for Intellitorq Electronic Torque Indicating Driver

Gauthier Biomedical received FDA 510(k) clearance to market its Intellitorq® electronic torque indicator, marking the first 510(k) clearance for such a device. The manual driver, called ITQ® for short, is designed to accurately indicate a preset torque value using LED lights and haptic feedback.

Gauthier Biomedical manufactures instruments for spine, trauma, hip, shoulder, knee, ankle and small bone surgical applications.

“Torque devices and final-tightening needs have long been a source of frustration for quality, regulatory and engineering departments,” said Michael T. Gauthier, President of Gauthier Biomedical. “This new product category of smart instrumentation creates a major market disruption…it will improve patient safety, exponentially drive value and eliminate costly recalibration programs.”

Source: Gauthier Biomedical

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