- FDA listing establishes status within the US regulatory framework
- Reinforces NeuroStrip’s credentials as a medical-grade device
- Registration will meaningfully support NeuroStrip’s positioning for advanced clinical rehabilitation
- Applications also submitted for regulatory approval in additional key jurisdictions
Control Bionics’ (ASX:CBL) NeuroStrip surface EMG wearable platform has been successfully registered and listed with the US Food and Drug Administration (FDA) as a medical device.
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CEO and MD, Jeremy Steele, said it formally establishes NeuroStrip within the US medical device regulatory framework.
“This FDA registration is an important milestone for Control Bionics and for NeuroStrip. 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,” Mr Steele said.
“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. 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,” said Mr Steele.”
The FDA registration and listing formalises NeuroStrip’s recognised status in the US medical device market, one of the world’s largest and most influential healthcare markets.
Mr Steele said in particular, 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.
“The company views this registration as an important step in accelerating its growth strategy across all three NeuroStrip application areas – performance, rehabilitation, and research and data – and as a further building block in Control Bionics’ 25 year plus legacy as an innovative medtech business,” he said.
“Combined with the company’s pending applications for TGA registration, CE marking and UK MDR registration, this reflects the breadth and pace of Control Bionics’ regulatory strategy as it continues to scale NeuroStrip into new markets and deepen adoption with existing partners.”
CBL is up 4.62% to 6.8¢. Mkt cap $28.94M.
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