Gauthier Biomedical announces 510(k) FDA approval to market Intellitorq

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Gauthier Biomedical’s Intellitorq, a manual driver that accurately indicates a preset torque value using LED lights and haptic feedback.

Gauthier Biomedical, a manufacturer of orthopaedic instruments and medical devices, has announced that it is the first company to achieve 510(k) approval by the US Food and Drug Administration (FDA) to market an electronic torque indicating device. Intellitorq (ITQ) is a manual driver that accurately indicates a preset torque value using LED lights and haptic (tactile) feedback.

Michael T. Gauthier, president of Gauthier Biomedical, comments: “This breakthrough in handheld medical devices represents Gauthier’s long-standing commitment to providing repeatability, reliability and accuracy to medical device OEMs. Torque devices and final-tightening needs have long been a source of frustration for quality, regulatory and engineering departments.”

“This new product category of smart instrumentation creates a major market disruption the likes of which we haven’t seen in quite some time. It will improve patient safety, exponentially drive value and eliminate costly recalibration programs.”

With products for hip, knee, shoulder, trauma and spine, Gauthier Biomedical provides a range of patented technologies designed to improve surgical techniques.

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