machineMD’s neos is aimed at evolving the diagnosis of a range of eye conditions in neuro-ophthalmology. Image credit: machineMD.

Swiss medical device company machineMD has obtained Class IIa medical device certification for its Virtual Reality (VR) headset device, Neos, for the assessment and diagnosis of ophthalmic disorders under the European Union’s (EU) revised Medical Device Directive (MDR).

Users undergoing an examination with Neos view gamified graphics via the device’s VR headset, which measures the resulting eye movements and pupillary changes of each eye, with medical technician-controlled examinations lasting between three and 12 minutes.

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Intended for use in medical settings by ophthalmologists or neurologists, the device monitors visual metrics including gaze holding, ocular alignment, pupillary function, and saccades. All of which may be signifiers of ocular diseases or the onset of neurodegenerative conditions like Parkinson’s disease.

MachineMD claims Neos has the potential to inform millions of examinations each year, providing objective quantifiable measurements that are generated into reports for clinicians that are stored on its cloud-based platform and exportable to electronic health record (EHR) systems once an examination is complete.

Neos’ Quality Management System (QMS) has also been certified as compliant with the ISO 13485:2016 standard for Medical Devices by TÜV Italia.

MachineMD CEO and co-founder, Dominic Senn, commented: “The EU-MDR Class IIa certification for Neos underscores our commitment to providing innovative devices that enhance the capabilities of healthcare professionals in neurology and ophthalmology.

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“This is a significant enabler for precision medicine, and further enables our research collaborations for people with Parkinson’s, multiple sclerosis (MS), myasthenia and other rare diseases.”

In April 2024, machineMD and Oxford, UK-based partner gaitQ received a £1m grant from Innovate UK to initiate an 18-month study on movement in Parkinson’s disease patients.

MachineMD has recently also forged partnerships with VR/XR hardware and software developer Varjo for the early diagnosis of brain disorders, and digital health expert Evoleen.

In June 2024, research presented at the European Neuro-Ophthalmology Society (EUNOS) meeting in Rotterdam, the Netherlands, demonstrated the potential of machineMD’s neos to visualise different phenomena of oculomotor impairment and symptoms of muscular fatigue of eye movements in patients with rare eye muscle weakness condition Myasthenia Gravis (MG).

Due to the challenges in meeting the requirements of the EU MDR, some observers have branded the new regulation a “disaster”.