Press

RadiusXR Achieves ISO 13485 and MDSAP Certifications, Announces Expansion into Canadian Market

RadiusXR

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3 June 2024

PLEASANTON, Calif.‐‐ RadiusXR, a leading innovator in digital health technology, is proud to announce that it has received ISO 13485 certification and the enhanced Medical Device Single Audit Program (MDSAP) certification. These prestigious certifications mark a significant milestone in RadiusXR’s commitment to delivering the highest quality standards and regulatory compliance in the medical device industry.

With the attainment of these certifications, RadiusXR is excited to announce its entry into Canada, one of the most requested markets.

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Expansion into North American Market

With the attainment of these certifications, RadiusXR is excited to announce its entry into Canada, one of the most requested markets. This strategic expansion allows RadiusXR to bring its cutting-edge glaucoma management and virtual reality perimetry (VRP) solutions to a broader audience of clinicians and patients.

Clinical Validation and NOVA Clinical Trial Results

RadiusXR’s platform is clinically validated and peer-reviewed, featuring groundbreaking advances in glaucoma management and VRP. Recently published in Translational Vision Science & Technology (TVST), the NOVA Clinical Trial demonstrated the exceptional accuracy and reliability of RadiusXR’s solutions. Key findings from the trial include:

A remarkable 0.94% correlation in mean deviation confirms the precision of RadiusXR’s measurements.
Statistical non-inferiority to traditional methods when staging glaucoma using Medicare definitions.
Unique photopic range measurement, consistent with industry standards, ensuring reliable clinical comparisons.

Innovative Features and Technology

RadiusXR’s innovative platform includes several unique features that set it apart from other solutions on the market:

Custom-Built Headset: The VRP is designed and manufactured specifically for ophthalmology, featuring micro-display, broad dynamic range, and all-day battery life.
Radius In-Live®: Real-time patient exam monitoring with gaze tracking and reliability indications, providing instant alerts and detailed exam progress views.
EHR Integration: Seamlessly integrates with existing Electronic Health Records systems, adhering to DICOM conformance standards and supporting FHIR connect HL7 and DICOM Modality Worklist (DMDL).
EYEVIA®: An immersive patient education and practice efficiency portal that allows clinicians to create and replay custom educational content, enhancing patient adherence and education.
Quick Orders: Streamlines the order creation process by bypassing repetitive configuration steps, improving workflow efficiency.

About RadiusXR

The RadiusXR platform is a revolutionary portable vision testing and patient engagement system. It combines advanced vision assessment tools, business management resources, and patient education features within a wearable spatial computing device. The RadiusExam® software and proprietary algorithms deliver reliable visual field data consistent with established clinical methods. This comprehensive hardware and software system empowers medical professionals to efficiently assess visual function, enhance patient engagement, and optimize clinical workflow. It enables patients to perform self-guided vision exams with minimal supervision, supporting the growth, flow, and efficiency of eye care practices.