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

PLEASANTON, Calif.–(BUSINESS WIRE)–#Ophthalmology—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.

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 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.

More About Radius XR:

The Radius XR (www.RadiusXR.com) platform is a revolutionary 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 comprehensive digital health platform combines proprietary hardware and software to empower medical professionals to diagnose patients accurately, enhance patient engagement, and reduce staff workload. It enables patients to perform self-guided vision exams with minimal supervision, thereby aiding in the growth of eye care practices.

For more information about RadiusXR and its revolutionary solutions, please visit RadiusXR.com.

Contacts

Media:
John Trefethen, MFA

Chief of Product

Media Kit
Media@RadiusXR.com
RadiusXR.com