machineMD’s neos receives EU-MDR Class IIa Certification to advance neuro-ophthalmic diagnostics

machineMD has received EU-MDR Class IIa certification for its neos™ neuro-ophthalmic diagnostic device, setting a new standard for eye movement and pupil function assessment in neurology and ophthalmology.

Bern-based medical device company machineMD has announced that its innovative device, neos™, has been certified as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This certification, granted by TÜV SÜD Danmark, represents a significant milestone in neuro-ophthalmic diagnostics, as neos™ is the first device to comprehensively assess eye movements, pupillary function, and visual fields using advanced technology.

neos™ is already being used by healthcare professionals in Switzerland and the US, where it is transforming clinical practice. The device supports the diagnosis and monitoring of neuro-ophthalmic conditions such as double vision and vision loss by providing objective, quantifiable measurements through a virtual reality (VR) headset. With examination sequences lasting as little as three minutes, neos™ improves the efficiency of clinical workflows and can be operated by medical assistants or technicians.

Bringing precision medicine closer to everyday clinical practice

The development of neos™ began at the University Hospital of Bern, Inselspital, and was supported by collaborations with CSEM and Helbling Technik, co-funded by Innosuisse. The device builds on decades of clinical research in neuro-ophthalmology and offers healthcare professionals a state-of-the-art tool for functional vision assessment, particularly in primary and secondary care.

In addition to achieving EU-MDR certification, machineMD’s Quality Management System has been certified as compliant with the ISO 13485:2016 standard, further demonstrating the company’s commitment to excellence in medical device development.

“Receiving the EU-MDR Class IIa certification for neos™ is a testament to our dedication to providing innovative solutions that enhance the capabilities of healthcare professionals,” said Dominic Senn, CEO and co-founder of machineMD. “This achievement will further enable our research collaborations in the areas of Parkinson’s, Multiple Sclerosis, and other neurological diseases.”