Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor

MedDevice Startups Staff · 2 days ago · 2 min read · Via TipRanks (company announcement)

Control Bionics has CE marked NeuroStrip as a Class I device under the EU Medical Device Regulation. The Australian company (ASX: CBL) can now distribute the wearable sensor across the EU, the EEA and Northern Ireland. NeuroStrip reads surface EMG and returns it to clinicians as measurement and biofeedback rather than diagnosis.

The mark closes out a sequence that started in the US. Control Bionics completed FDA establishment registration and device listing for NeuroStrip in August 2026, under listing number D605008 and registration number 3006789226. Great Britain followed. The TGA application in Australia is still open.

Class I self-certification is the cheapest door into Europe, and the non-diagnostic biofeedback claim is what keeps NeuroStrip on that side of the line. Any claim that the output informs a diagnosis would push the device up a class and put a notified body in the file.

The company is selling into rehabilitation clinics and sports science groups, and carries a market capitalization of about A$33M.

Questions & Answers

Did Control Bionics get a CE mark for NeuroStrip?

Yes. Control Bionics CE marked NeuroStrip as a Class I device under the EU Medical Device Regulation in early October 2026, clearing it for distribution in the EU, the EEA and Northern Ireland.

What is the Control Bionics NeuroStrip used for?

NeuroStrip is a wearable surface EMG sensor from Control Bionics. It measures muscle electrical activity for clinicians, rehabilitation providers, researchers and sports organizations, and the company positions it as a non-diagnostic measurement and biofeedback tool.

Where is Control Bionics NeuroStrip authorized for sale?

As of October 2026 Control Bionics holds NeuroStrip authorizations in the United States, Great Britain and Europe. An Australian TGA application is still pending.

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