Laboratory_medicine
DreaMed Advisor Pro
DreaMed Diabetes Ltd
FDA-cleared AI medical device
An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.
FDA Submission Metadata
- Submission number
- K191370
- Decision date
- July 2019
- FDA panel
- Clinical Chemistry
- Product code
- QCC
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.