RadiusXR has achieved ISO 13485 certification and obtained Medical Device Single Audit Program (MDSAP) certification. Consequently, the company is expanding into the Canadian market, broadening the clientele for RadiusXR's glaucoma management and virtual reality perimetry (VRP) solutions.
RadiusXR’s platform is clinically validated and peer-reviewed, featuring 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 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.
RadiusXR's 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 microdisplay, 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.
The Radius XR platform is a portable vision diagnostic and patient engagement system. It combines medical-grade diagnostics, business management tools, and patient education resources within a wearable spatial computing device. The RadiusExam and proprietary algorithms provide diagnostic testing results equivalent to current gold standards demonstrated through a clinical trial that shows statistical noninferiority of estimated sensitivities compared to SITA-Standard. This digital health platform combines proprietary hardware and software to empower medical professionals to diagnose patients accurately, enhance patient engagement, and reduce staff workload.