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EDGe Surgical’s Innovative EDG® Ortho 65mm Depth Gauge Gains CE Mark Approval

EDGe Surgical has reached a remarkable milestone by securing CE Mark approval for its pioneering EDG® Ortho 65mm single-use electronic depth gauge. This accomplishment marks a significant advancement in orthopedic surgical tools, promising greater precision and safety during orthopedic fracture surgeries.

The EDG Ortho represents a revolutionary, sterile, single-use device designed to address a critical aspect of orthopedic surgery: determining the appropriate screw length for implantation during fracture surgeries. Ensuring the precise screw length is crucial for the success of these procedures and the patient’s overall well-being. The EDG Ortho has been meticulously crafted to provide surgeons with a dependable tool, minimizing the potential for error and elevating patient safety.

Christopher Wilson, CEO of EDGe Surgical, emphasized the significance of this approval, particularly in light of the evolving regulatory landscape within the medical device industry. He commented, “The preparations required to comply with the new Medical Device Regulation (MDR) have placed a substantial burden on large orthopedic manufacturers. Some have even had to discontinue certain products due to compliance challenges. Our EDG Ortho electronic depth gauge provides a readily available solution for manufacturers struggling with the transition from legacy metal depth gauges to meet the more stringent MDR requirements.”

The EDG Ortho 65mm single-use electronic depth gauge not only meets the stringent MDR requirements but also offers multiple advantages over traditional metal depth gauges. It eliminates the need for sterilization and reprocessing, reducing the risk of infection transmission in the operating room. Moreover, its electronic functionality ensures precise measurements, minimizing the likelihood of surgical complications.

The CE Mark approval now enables EDGe Surgical to offer this groundbreaking device to orthopedic manufacturers and healthcare providers across Europe, potentially revolutionizing orthopedic fracture surgeries by enhancing accuracy and safety in screw implantation procedures. This achievement underscores EDGe Surgical’s commitment to innovation and patient safety in the realm of orthopedic surgery, ultimately promising to improve patient outcomes and the quality of care provided.

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