Control Bionics (ASX:CBL) has successfully registered and listed its NeuroStrip surface EMG wearable platform with the US Food and Drug Administration (FDA) as a medical device.

FDA establishment registration and device listing is a formal step that places a manufacturer and its product on the agency's registry. It is distinct from 510(k) clearance or premarket approval, which apply to higher-risk devices requiring evidence of safety and effectiveness. For companies targeting clinical research and rehabilitation markets, however, registration and listing can serve as a baseline credential that institutional buyers and partners expect before engaging.

NeuroStrip uses surface electromyography — sensors placed on the skin to detect electrical signals generated by muscles — to capture movement intent and muscle activity data. The platform is designed across three application areas: sports performance, rehabilitation, and research and data, including potential human-computer interface applications.

CEO and Managing Director Jeremy Steele said the registration formally establishes NeuroStrip within the US medical device regulatory framework.

"This FDA registration is an important milestone for Control Bionics and for NeuroStrip," Mr Steele said. "It is a significant credential in its own right, and while NeuroStrip already supports sports performance and everyday rehabilitation use without requiring this level of regulatory status, formal recognition under the US medical device framework meaningfully strengthens our position in advanced clinical rehabilitation, medical research and future human-computer interface applications, where customers and partners expect a recognised regulatory foundation."

The FDA registration and listing formalises NeuroStrip's status in the US medical device market, one of the world's largest and most influential healthcare markets. Mr Steele noted that the registration is expected to support engagement with advanced clinical rehabilitation providers, medical research institutions, and future human-computer interface and medtech development partners, where formal US regulatory recognition is often a baseline requirement for engagement.

"This registration builds on our 25-year-plus legacy as an innovative medtech business and supports our strategy to accelerate growth across all three NeuroStrip application areas — performance, rehabilitation, and research and data," Mr Steele said. "Combined with our pending TGA, CE and UK MDR applications, it reflects the breadth of our regulatory strategy as we continue to scale NeuroStrip into new markets and deepen adoption with existing partners."

The company views the registration as a further building block in Control Bionics' 25-year-plus legacy as an innovative medtech business and an important step in accelerating its growth strategy across all three NeuroStrip application areas.

Control Bionics also has pending applications for TGA registration, CE marking, and UK MDR registration, reflecting the breadth and pace of its regulatory strategy as it continues to scale NeuroStrip into new markets and deepen adoption with existing partners.

CBL shares were up 4.62% at 6.8 cents, with a market capitalisation of $28.94 million.