
Control Bionics (ASX:CBL) has registered its NeuroStrip wearable device with the US FDA under listing number D605008.
While not required for sports performance, the listing establishes formal regulatory standing in the United States healthcare market.
"This registration builds on our 25 year plus legacy and supports our growth strategy," said Control Bionics CEO Jeremy Steele.
The company stated that pending regulatory applications include Australia's TGA, European CE marking, and United Kingdom MDR framework.
Following the announcement, the Control Bionics share price was up 4.62% at $0.066.
Control Bionics historically focused on non-invasive surface electromyography technology to assist individuals with assistive communication.