Regulatory approval for MachineMD and Positrigo’s devices

Based in Bern with an office in Boston, machineMD, a medtech startup at the intersection of neuroscience and ophthalmology, is proud to announce its visionary medical device, neos, is certified as a Class IIa medical device under the European Union Medical Device Regulation. This certification sets a new standard in the fields of neurology and ophthalmology, making neos the first EU-MDR medical device that comprehensively assesses eye movements, pupillary function, and visual fields, supporting the diagnosis and monitoring of neuro-ophthalmic conditions such as double vision and vision loss. The neos examination enables patients to watch an intuitive sequence of gamified graphics via an industry-leading VR headset, which measures the resulting eye movements and pupillary changes of each eye. With examination sequences as short as three minutes, and operable by a medical assistant or technician, neos is poised to bring significant efficiency gains to clinical workflows. It is already in use by neurologists, ophthalmologists, and optometrists in Switzerland and the USA, and is making a significant impact in clinical practice.

In addition to the certification of neos, machineMD announced that the company’s Quality Management System has been certified as compliant with the ISO 13485:2016 standard for Medical Devices by TÜV Italia. This certification covers the design and development, manufacturing, and placing on the market of active non-implantable devices, further demonstrating machineMD's dedication to quality and excellence in the fields of neurology and ophthalmology monitoring and diagnosis.

First Startup with Two Approvals
Positrigo, the developer of nuclear medical imaging devices to advance functional brain imaging, has received the CE Mark in Europe for its dedicated brain Positron Emission Tomography (PET) system NeuroLF. The NeuroLF system is the first device of its kind that received market clearance in Europe and in the US. NeuroLF is an ultra-compact and affordable device that assists in diagnosing and monitoring brain-related disorders like Alzheimer’s disease, brain tumors, epilepsy, Parkinson’s disease, and others. These two market approvals are important milestones for commercial opportunities in other parts of the world. As such, Positrigo plans to sell its novel technology in Europe by leveraging a network of established companies in selected countries.

“The CE mark of the NeuroLF system is another important milestone in the development of this dedicated brain PET system and represents a significant advance in the availability of brain PET imaging, allowing nuclear medicine physicians in Europe to offer a dedicated imaging modality to diagnose and monitor patients with brain-related disorders,” says Prof. Dr. med. Osama Sabri, Director and Chairman of the Department of Nuclear Medicine at the University of Leipzig Medical Center. This version includes all suggested corrections for improved clarity and consistency.

(Press release/RAN)