DSG is a sensing technology used to secure and streamline the placement of bone implants

FDA device

The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

SpineGuard has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Dynamic Surgical Guidance (DSG) Connect platform.

DSG is a sensing technology that is designed to secure and streamline the placement of bone implants.

The FDA clearance facilitates the commercial launch of the new generation of PediGuard probes and smart screws for spine surgery in the US, and transmits their X-Ray free and real-time information with the DSG Connect module.

The signal sent by the DSG sensor will be received by a wireless tablet interface embedded with a software application and a visual rendering is added to the audio feedback to improve its exploitation in the operating room.

It will help in the data recording for the purpose of medical-legal evidence, in addition to the performance of clinical studies on the topic of bone quality.

The platform, which is already used experimentally to guide orthopaedic surgical robots, is designed for integration within robotic and navigation systems.

SpineGuard cofounder and deputy CEO Stéphane Bette said: “This FDA clearance opens the doors of the American market to our X-Ray free real time surgical guidance, from now on connected and more powerful thanks to new functionalities.

“It also affirms SpineGuard’s position as a significant player in digital surgery. DSG has the potential to be deployed throughout the entire orthopedic and dental fields, and in particular in robotic applications.”

In June last year, the company announced first surgeries with its new DSG Connect platform at the Fondation Hopale and the Centre Hospitalier Universitaire de Lille in France a few weeks after obtaining the CE mark.

The company claims that medical devices developed by it have been used in over 80,000 surgical procedures worldwide.

In February 2017, SpineGuard secured US patent to use the DSG technology in a new application called bone quality measurement.