Vivior Clears Key Regulatory Hurdle in Advance of U.S. Launch


ZURICH—The U.S. Food and Drug Administration’s (FDA) has approved the regulatory strategy for the Vivior Monitor, a device that collects patient data used in cataract and refractive surgery. The move helps pave the way for Vivior’s U.S. launch of the Monitor, a wearable device that tracks and records the patient's behavioral data prior to vision correction interventions. The system collects daily activity data from patients, processes the data in the cloud, and patient's lifestyle patterns using machine-learning algorithms. It provides the surgeon with a patient report so that the surgeon can educate the patient during the pre-op planning discussion.

"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 which can be misleading due to what is known in psychology as memory bias," said Paul Soye, a member of the board of directors for Vivior, based here. “The Vivior Monitor consists of sensors measuring distance, ambient light and color, an accelerometer, a gyroscope, and a magnetometer.”

Pavel Zakharov, chief technology officer of Vivior, noted, “The Vivior Monitor does not have 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 is converted into patient behavioral data using state-of-the-art artificial intelligence algorithms and provided to the surgeon in the form of intuitive visuals."

Vivior is a Swiss digital health start-up founded in 2017 by a group of experienced eyecare professionals.