First Microsoft HoloLens Augmented Reality System FDA-Approved For Surgical Use

This week, the FDA granted the Microsoft HoloLens 510(k) clearance for use with Novarad’s OpenSight Augmented Reality System. Opensight uses AR in an application format that enables pre-operative planning. Novarad claims that OpenSight will utilize two, three, and four-dimensional images portrayed on the patients’ bodies to yield a visual representation of what surgeons may encounter while operating. This technologys is the first AR system of its kind to receive clearance from the FDA.

Novarad’s OpenSight utilizes HoloLens to give the user an optimal experience, allowing simultaneous visualization of 3D patient images in AR and the actual patient. AR differs from VR in the sense that one can still perceive what is actually present. The augmentation simply comes from adding aspects to the existing setting, whereas in VR the user is immersed in a completely virtual scenario with no traces of the true surroundings. The goal of OpenSight is to improve surgical planning and reduce the amount of time spent in the operating room by providing surgeons with a visual and interactive guide of the patient prior to operation.

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“This is transformative technology that will unite preoperative imaging with augmented reality to improve the precision, speed and safety of medical procedures,” said Dr. Wendell Gibby, Novarad CEO and co-creator of OpenSight. “This internal visualization can now be achieved without the surgeon ever making an incision, improving outcomes in a world of more precise medicine.”

Use of OpenSight in pre-operative planning allows surgeons to highlight relevant features and fatal structures to avoid. They can also use virtual positioning tools to evaluate different surgical approaches and angles to see the best way to go about operation. This can significantly reduce operation times, being that these surgical approach challenges are often tackled in real time while the operation has begun.

OpenSight also allows multiple users to use headsets to confer on the same AR experience. This aspect of the HoloLens-AR system is useful for training of early residents. The AR application also offers a teaching version of the technology for medical students, allowing them to perform virtual cadaver dissections.

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In addition to the coupling of its technology with Microsoft’s HoloLens, Novarad’s OpenSight also uses 3D processing from Nova3D+ products to generate its unique interactive experience. On Novarad’s page for OpenSight, they claim that the system, “Renders patients’ imaging studies into 3D and presents them in an interactive manner. This gives radiologists, physicians, surgeons, and students the incredible ability to interact with the imaging data as well as see these images displayed in the anatomically correct location on the patient.”

Sources: Novarad, BusinessWire, HealthImaging