Tidepool's diabetes management tool receives 510k clearance
The Tidepool Loop app connects to compatible continuous glucose monitors and pumps and helps Type 1 diabetes patients determine whether insulin levels should be adjusted.
Nonprofit diabetes management startup Tidepool received 510(k) clearance for its Tidepool Loop, an automated insulin dosing app that can enable insulin delivery from a compatible Apple Watch.
The app can be used with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled pumps. An algorithm helps users determine whether basal insulin delivery should be increased, decreased or suspended based on the iCGM readings and predicted glucose values.
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