FDA Finds ImmersiveTouch’s 3D Virtual Reality Software Wasn’t Validated

ImmersiveTouch failed to validate its software for creating 3D virtual reality models from a patient’s computed tomography and magnetic resonance imaging data, the FDA found in an inspection of the company’s Chicago facility.

The ImmersiveTouch software, which enables clinicians to visualize the patient’s anatomy in three dimensions, is classified as a Class II device.

The agency said design input and output requirements weren’t reviewed and approved for version 2.0 of the software.