{"id":27387,"date":"2024-10-14T10:45:54","date_gmt":"2024-10-14T08:45:54","guid":{"rendered":"https:\/\/ggba.swiss\/?p=27387"},"modified":"2024-10-14T10:46:29","modified_gmt":"2024-10-14T08:46:29","slug":"machinemds-neos-receives-eu-mdr-class-iia-certification-to-advance-neuro-ophthalmic-diagnostics","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/en\/machinemds-neos-receives-eu-mdr-class-iia-certification-to-advance-neuro-ophthalmic-diagnostics\/","title":{"rendered":"machineMD\u2019s neos receives EU-MDR Class IIa Certification to advance neuro-ophthalmic diagnostics"},"content":{"rendered":"\n

Bern-based medical device company <\/em>machineMD<\/a> has announced that its innovative device, neos\u2122, has been certified as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This certification, granted by T\u00dcV S\u00dcD Danmark, represents a significant milestone in neuro-ophthalmic diagnostics, as neos\u2122 is the first device to comprehensively assess eye movements, pupillary function, and visual fields using advanced technology.<\/p>\n\n\n\n

neos\u2122 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\u2122 improves the efficiency of clinical workflows and can be operated by medical assistants or technicians.<\/p>\n\n\n\n

Bringing precision medicine closer to everyday clinical practice<\/h4>\n\n\n\n

The development of neos\u2122 began at the University Hospital of Bern, Inselspital<\/a>, and was supported by collaborations with CSEM<\/a> 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.<\/p>\n\n\n\n

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\u2019s commitment to excellence in medical device development.<\/p>\n\n\n\n

“Receiving the EU-MDR Class IIa certification for neos\u2122 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\u2019s, Multiple Sclerosis, and other neurological diseases.”<\/p>\n\n\n\n

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