Michael Mrochen, Chairman of the Board of Directors of Vivior, comments: "We are very pleased with the confirmation of our regulatory strategy by the Food and Drug Administration that will allow us to support patients and surgeons in the US market within the next months."
Paul Soye, Member of the Board of Directors of Vivior, adds: “Currently, cataract and refractive surgeons, as well as optometrists, rely on personal information about visual needs communicated by patients either verbally or in written form. The information provided through these surveys can be misleading due to what is known in psychology as Memory Bias.”
Pavel Zakharov, Chief Technology Officer of Vivior, explains: “The Vivior Monitor consists of sensors measuring distance, ambient light and color, an accelerometer, a gyroscope, and a magnetometer. The Vivior Monitor does not include a camera or any other sensors which might infringe the privacy of the patient or other people. The recorded data are uploaded to the cloud when the system is returned for processing and analysis. Sensor data are converted into patient behavioral data using state-of-the-art artificial intelligence algorithms and provided to the surgeon in the form of intuitive visuals.”
Vance Thomson, MD, Member of the Medical Advisory Board of Vivior, adds: “The system also provides the surgeon with a patient report so that the surgeon can educate the patient during the pre-op planning discussion.”