Yesterday, Zynex, Inc. announced that its new blood volume monitor medical device would be entering its first clinical evaluation, to be performed by OmniaVicinit, Llc. The device is being developed by Zynex Monitoring Solutions, a subsidiary.
Zynex is a provider of pain management systems and electrotherapy products for medical patients with functional disability. The company engineers, manufactures, markets and sells its own design of medical devices under three subsidiaries: Zynex Medical, Zynex Monitoring Solutions, and Zynex NeuroDiagnostic. The Zynex product line is FDA approved and is intended to improve quality of life for sufferers of strokes, spinal cord injuries and chronic pain.
The Zynex blood volume monitor is a device intended to detect blood loss during surgery and any internal bleeding during the recovery process. Zynex sees the device as fulfilling an unmet need in the medical industry, and believes it will lead to safer surgery and recovery monitoring. OmniaVicinit, the organization performing the product’s evaluation, facilitates development of clinical research programs, non-traditional clinical studies, as well as investigative site quality support.
Zynex’s CEO, Thomas Sandgaard, said, “We are very excited about the development and prototyping of our cardiac monitor for blood volume. We are starting the next phase of collecting data to further validate the algorithm used to non-invasively determine changes in central blood volume. We expect to use the data for defining further clinical studies, as well as to provide substantiation for FDA submission and international regulatory clearance.”