KNoW Biological makes a wearable monitor, the VoLI, that can alert people who have epilepsy to seizures as much as 40 minutes before they happen. More than 65 million people in the world have epilepsy; nearly 4 million in the United States. Thirty-five percent of people who have epilepsy have seizures that cannot be controlled. These people live in constant fear, never knowing when their next seizure will occur. VoLI provides critical early warning, allowing users time to get somewhere safe and communicate with family, friends, or healthcare providers.

As part of the Breakthrough Device evaluation process, the FDA reviewed initial limited clinical trials, investigative science, and preliminary research. Since the inception of the program, only a small number of neurological devices have been granted this status. With Breakthrough Device designation, full-scale clinical trials for the VoLI can begin along with seeking a second round of investor funding to facilitate ongoing development of the multi-patented device.