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Parkinson’s Insights share our latest clinical publication and transitional journey towards Class IIa medical device certification

Charco Neurotech prepares to relaunch CUE1+ following trial findings and medical device certification.

 

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Parkinson’s UK share our latest clinical publication

Results from a clinical trial of CUE1+, a chest-mounted device, has shown it’s well tolerated by people with Parkinson’s and has the potential to help manage movement symptoms.

 

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Charco Neurotech announces publication of a pilot RCT, with data highlighting that the CUE1+ is safe, well tolerated, with encouraging signals for motor symptom relief in people with Parkinson’s

A double-blind, placebo-controlled study of 50 people with Parkinson’s, published in Parkinson’s Disease, part of the Nature Portfolio, is the first randomised sham-controlled trial of the sternum-worn therapeutic device 

CAMBRIDGE, UK, 11th August 2026 — Charco Neurotech, the Cambridge-based neurotechnology company behind the CUE1+ wearable, today welcomed the publication of an independently conducted, randomised, double-blind, placebo-controlled pilot trial of the device in people with Parkinson’s disease, published in npj Parkinson’s Disease. 

The study, led by researchers at Queen Mary University of London’s Centre for Preventive Neurology and run across Barts Health NHS Trust and Homerton Healthcare NHS Foundation Trust, is the first sham-controlled randomised trial of CUE1+, a non-invasive, sternum-worn device that uses vibrotactile stimulation to support movement in people with Parkinson’s. 

Fifty adults with idiopathic Parkinson’s disease, stable on their usual medication, were randomly assigned to wear either an active CUE1+ device or an indistinguishable sham device for eight hours a day over 12 weeks. Neither participants nor assessors knew which device each person had been given.

 

KEY FINDINGS 

The trial was designed primarily to assess usability, safety, and tolerability, and found the device performed strongly against all three measures. Alongside these primary findings, the trial also measured exploratory clinical outcomes. Participants using the active device showed a mean 11.1-point greater improvement on the MDS-UPDRS Part III motor score than the sham group (95% CI −17.3 to −4.9), and a mean 7.6-point greater improvement on the PDQ-39 quality-of-life index (95% CI −12.3 to −3.0), both assessed while participants were on their normal medication. 

 

QUOTES 

“People with Parkinson’s have limited non-invasive treatment options that can be integrated into everyday life. This trial showed that the CUE1+ device was safe, well tolerated and used consistently over 12 weeks of daily home use. While this pilot study was not designed to establish clinical efficacy, the encouraging exploratory findings in motor symptoms and quality of life provide a strong rationale for larger, adequately powered trials to determine whether wearable vibrotactile stimulation can deliver meaningful benefits alongside standard Parkinson’s care.” 

Dr Cristina Simonet, Principal Investigator, Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London. 

 

“We set out to conduct a study that would be run independently of Charco, with a real sham control, because people with Parkinson’s deserve solutions that are backed by robust clinical evidence to give them the best possible information when considering treatment for their symptoms. The team at Queen Mary, Barts Health and Homerton have delivered exactly that, and the fact that the CUE1+ came through as safe, well tolerated, and with highly encouraging efficacy signals is a truly important milestone for us. We’re working hard to make the CUE1+ available to those people who could benefit from it, and looking at what a larger, fully powered trial would involve.” 

Andrew Mullen, Chief Executive Officer, Charco Neurotech. 

 

“These findings are an important step forward in understanding the potential benefits of vibrotactile cueing devices for the Parkinson’s community. Whilst larger, longer trials are needed to further explore the potential of CUE1+, it’s encouraging to see that the device was well tolerated and saw an improvement in movement symptoms. These findings suggest that CUE1+ has potential as a complementary intervention alongside standard Parkinson’s treatments.” 

Emma Rodgers, Research Communications Manager at Parkinson’s UK. 

 

ABOUT THE STUDY 

“Sternum-worn vibrotactile device in Parkinson’s disease: a randomised, double-blind, placebo-controlled pilot trial” was published in npj Parkinson’s Disease on 3 July 2026 (DOI: 10.1038/s41531-026-01448-y). The trial is registered on ClinicalTrials.gov (NCT06174948). It was supported by a UK Research and Innovation Knowledge Transfer Partnership (2021–2022, round 4) and by Charco Neurotech Ltd, which supplied CUE1+ and sham devices. As stated in the published paper, the funders had no role in study design, data collection, analysis, interpretation, or the writing of the manuscript.  

 

The mission continues.
Move Freely. Live Fully.

Charco Neurotech Achieves ISO 13485:2016 Certification

We are proud to announce that we have achieved ISO 13485 certification, the internationally recognised quality management system standard for Medical Devices, issued by Kiwa Ltd, a UKAS-accredited certification body. This marks a pivotal step in our mission to bring CUE1+ to people with Parkinson’s through healthcare systems worldwide.

What ISO 13485 means

ISO 13485 is the global benchmark for quality management in medical device organisations. Achieving it is not a simple administrative exercise; it requires every part of an organisation to demonstrate that its processes, systems, and controls consistently meet the rigorous standards expected of a regulated medical device company, from initial design through to post-market customer support.

Certification across both of our sites confirms that Charco Neurotech operates consistently and verifiably at the level expected of a truly global medical device company from the facility where CUE1+ is designed and manufactured, to the team dedicated to delivering it into the hands of those who need it most.

Our certified sites

Importantly, this certification spans our entire international operation; both of Charco’s sites have been assessed and certified under the same standard.

What this means for the people we serve

For a company built around improving the lives of people with Parkinson’s, this means more than a compliance milestone.

  • It reinforces the care and precision that goes into every device we make.
  • For healthcare systems and clinical partners, it’s the foundation for meaningful collaboration.
  • And for global markets, it sends a clear signal: Charco Neurotech is primed for expansion.

CUE1+ is a non-invasive, drug-free wearable that uses vibrotactile stimulation to help people with Parkinson’s move more freely, reduce stiffness, and improve balance and stability. The evidence supports it. And now our quality framework verifiably matches our ambition.

“This certification confirms that Charco Neurotech operates at the standard required of a true global medical device company. It opens the door to healthcare system partnerships, clinical procurement pathways, and international market access, and ultimately means CUE1+ can reach more people with Parkinson’s, wherever they are in the world.”

Iain Strickland PhD, Chief Commercial Officer — Charco Neurotech

A step towards global healthcare access

ISO 13485 certification is a foundational requirement for engaging with regulated healthcare markets worldwide. As Charco Neurotech looks to expand access to CUE1+ through NHS procurement pathways, international regulatory frameworks, and clinical partnerships globally, this certification provides the verified quality foundation those conversations require.

CUE1+ deserves to be in the hands of every person with Parkinson’s who could benefit from it — wherever they are in the world. This milestone brings us meaningfully closer to making that a reality.

LFH Regulatory

A huge thank you to the team at LFH Regulatory, a specialist medical device regulatory consultancy, who have supported us every step of the way. Their expertise in QMS implementation made a genuinely complex journey manageable, and we couldn’t have got here without them.

Visit LFH Regulatory →

And to the entire Charco team, across Cambridge and South Korea — this achievement belongs to you.

The mission continues.
Move Freely. Live Fully.

The CUE1, created by Charco Neurotech, is being used by former BBC technology correspondent Rory Cellan-Jones

The CUE1, created by Charco Neurotech, is being used by former BBC technology correspondent Rory Cellan-Jones.

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