Device Name: VR Medical Imaging Platform
Author(s): Dahlia M. Kenawy, MD MS
Avatar Medical Software V1 (AMS V1) is a class II medical device that received FDA approval on May 24, 2023.
The AMS V1 is a software-only medical device that is designed to assist medical professionals with preoperative surgical planning through imaging processing and analysis.
This device consists of two components: a desktop and virtual reality (VR) interface, which require a compatible off-the-shelf desktop workstation and VR headset for use. DICOM compatible or PACS (picture archiving communication system) CT or MRI images are then uploaded and processed into 2D or 3D reconstructions, with the ability to measure, annotate, and apply filters in either a desktop or virtual reality (VR) interface. The desktop interface can also be streamed to other workstations within the local area network.
In addition to preoperative surgical planning, the software can also be used for surgical teaching. It is not approved for use in sterile environments, though the software can be used both inside and outside the operating room. The imaging software is not intended for patient viewing.
According to the FDA, the device is substantially equivalent to predicate devices. Unlike Ceevra Reveal 2.0, AMS V1 provides users with the ability to measure, add filters, and annotate images, in addition to remote streaming.
Resources: