FDA clears Spineart app for robotic-assisted spine surgery

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The FDA granted 510(k) clearance to Spineart’s Perla TL application for use with eCential Robotics’ Op.n Navigation and Robotic-Assisted Platform.

The clearance expands the application’s use with the Op.n platform to robotic-assisted workflows, according to an Aug. 26 news release. The companies previously established compatibility between Perla and the platform for navigation.

The application combines implant technology, real-time navigation and robotic assistance for open and minimally invasive spine procedures. It supports Spineart’s Perla TL Open and minimally invasive surgery pedicle screw systems.

The integration is designed to support implant placement accuracy, workflow efficiency and procedural confidence, according to the release.

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