Gauthier Biomedical receives FDA clearance for electronic torque indicating driver

Gauthier Biomedical (Grafton, Wisc.) announced that it has recently received FDA 510(k) clearance to market its electronic indicating device Intellitorq.

The Intellitorq device is a manual driver that can indicate a torque value using LED lights and haptic feedback.

“This breakthrough in handheld medical devices represents Gauthier’s long-standing commitment to providing repeatability, reliability and accuracy to medical device OEMs,” Michael T. Gauthier, president of Gauthier Biomedical, said. “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.”