Sira Medical has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's augmented reality preoperative surgical planning application.
The system provides clinicians with advanced imaging to assist in making key patient management decisions and address issues with patient anatomy that may be hidden by conventional imaging scans. Sira Medical highlighted its peer-reviewed studies which showed the application led to reduced operating time and a preference for using augmented reality models for surgical planning.