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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.
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:
RadiusXR’s innovative platform includes several unique features that set it apart from other solutions on the market:
The RadiusXR 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 hardware and software system empowers 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, flow and efficiency of eye care practices.
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