The system has been approved for intraoperative use in stereotactic spinal surgery. Credit: CHUTTERSNAP on Unsplash.

Novarad has received approval from Indonesia’s Food and Drug Administration (FDA) for its VisAR surgical navigation system.

Designed to use augmented reality, the system is intended for intraoperative use in stereotactic spinal surgery.

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The surgical navigation system is precise for both open and minimally invasive surgery.

Novarad’s comprehensive solution comprises pre-surgical planning, segmentation, virtual annotations and two-way image connectivity.

Surgeons can use the technology to convert a patient’s imaging data into a 3D hologram, allowing for accurate projection onto the patient’s body.

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This enables surgeons to focus entirely on the surgical objective without the need to divert their attention towards a separate monitor, ensuring precise surgical guidance.

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The system also offers integrated 2D and 3D immersive navigation views along with ongoing hologram-to-patient registration.

Furthermore, it has a sub-2mm accuracy rate for pedicle screw placement in open and minimally invasive surgical procedures.

VisAR facilitates a seamless set-up to help surgeons access the complete operating room footprint using voice-controlled commands.

The system uses advanced technology that leverages CT fiducial markers visible in medical images for automatic registration.

Novarad and Microsoft have joined forces to use pre-built AR headset technology, enabling cost savings and the utilisation of forthcoming hardware advancements.

Physicians wearing the wireless Microsoft HoloLens 2 visor through VisAR eliminate the necessity for any additional navigational equipment.

Novarad CEO and VisAR co-creator Dr Wendell Gibby said: “VisAR’s FDA approval in Indonesia is a testament to its innovative design and ability to improve patient outcomes.

“This technology will enable surgeons in Indonesia to perform complex procedures with greater accuracy and less risk, ultimately benefiting patients.”