A New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical Devices
- PMID: 29901411
- DOI: 10.1089/dia.2018.0142
A New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical Devices
Keywords: 10-day CGM; Clinical accuracy; Continuous glucose monitoring; Factory-calibrated; Glucose sensor; MARD; no calibration; stand-alone.
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