FDA approves HoloLens powered AR medical imaging system

November 08, 2018 // By Rich Pell
The Food and Drug Administration (FDA) has approved an augmented reality (AR) medical solution for Microsoft HoloLens for use in pre-operative surgical planning.

The OpenSight Augmented Reality System from medical imaging company Novarad (Salt Lake City, UT) is the first solution for Microsoft HoloLens to receive 510(k) clearance by the FDA for medical use. The system renders 2D, 3D, and 4D images of patients interactively while accurately overlaying them directly onto the patient's body, allowing doctors to both see the patient and into the patient simultaneously to more accurately plan surgery.

"This is transformative technology that will unite preoperative imaging with augmented reality to improve the precision, speed, and safety of medical procedures," says 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."

The system differs from previous preoperative planning systems that used virtual reality (VR). Unlike such systems, says the company, the HoloLens headset not only allows the user to simultaneously view both the 3D patient images (in AR) and the patient (reality), augmented reality also allows the user to see their complete real-world surroundings, avoiding the disorientation of virtual reality.

In addition, says the company, because the images are co-localized to the patient, augmented reality allows a much better understanding of anatomic relationships. Pre-operative planning with OpenSight makes it possible to highlight relevant anatomy and critical structures to avoid, as well as positioning virtual tools and guidance systems to more accurately plan a surgical approach.

Multiple headsets can also be shared among users, improving the training of less experienced residents. A teaching version of the software is also available that allows medical students to perform virtual dissections on cadavers.

Novarad

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