Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Continuous Glucose Monitor Informed Insulin Dose Calculator

FDA product code QRX · 6 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1358
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-01-27 – 2026-09-08

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

↑