— Clinical Accuracy Data
Accuracy parity. Zero ISF lag. Validated.
Controlled validation studies confirm optical MARD performance at clinical parity with cleared enzymatic CGM systems — without the physiological inference delay that introduces treatment-decision risk.
+ FDA Regulatory Pathway
Mapped milestones, not aspirations
Pre-submission meetings with FDA completed. De Novo classification pathway identified for the optical CGM category. Bench tested and biocompatibile
▸ Independent Validation
Clinical evidence available under NDA
Full study datasets, reference methodology, and comparative analysis against cleared enzymatic CGMs are packaged for diligence review. Regulatory counsel and clinical strategy teams receive complete documentation on first contact.