US Company Receives FDA Clearance for Augmented Reality Surgical Navigation in Indonesia

June 2023

US company Novarad has received approval from Indonesia’s Food and Drug Administration (FDA) for its VisAR surgical navigation system. Novarad’s VisAR uses augmented reality for intraoperative use in stereotactic spinal surgery. This technology enables surgeons to transform a patient’s imaging data into a 3D hologram, which can be projected onto the patient’s body with extreme precision. This allows surgeons to concentrate solely on the surgical objective without requiring them to look away towards a separate monitor.

The VisAR system is a comprehensive solution that includes pre-surgical planning, virtual annotations, segmentation, as well as two-way image connectivity. It also provides integrated 2D and 3D immersive navigation views and ongoing hologram-to-patient registration. VisAR has a sub-2 mm accuracy rate for pedicle screw placement in open and minimally invasive surgical procedures. With a fast a seamless set-up, VisAR enables the surgeon to view the entire or footprint with voice-controlled commands.

Novarad has collaborated with Microsoft to utilize pre-built augmented reality (AR) headset technology. With VisAR, physicians wear the wireless Microsoft HoloLens 2 visor and have no need for any other navigational equipment.

Apart from Indonesia, VisAR is currently available in the United States, with other countries expected to approve the technology in upcoming months.

(Source: Novarad Corporation)

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