Glooko Receives First-of-its-Kind FDA Clearance for Cloud-Based Insulin Dosing Platform

Glooko has received U.S. Food and Drug Administration 510(k) clearance for EndoTool IV Cloud, a cloud-based platform designed to support intravenous insulin dosing for hospitalised patients. 

According to the company, it is the first FDA-cleared cloud-based solution of its kind for patient-specific insulin dosing.

EndoTool IV Cloud is based on the existing EndoTool IV platform, which is used in hospitals to assist clinicians in managing insulin therapy for patients requiring intravenous insulin treatment. 

The new cloud-based version uses the same insulin dosing algorithm while introducing features that support remote deployment, centralised updates and easier system maintenance.
The FDA clearance marks an important step in the expansion of connected diabetes care across both inpatient and outpatient settings. 

By moving the platform to a cloud environment, hospitals may benefit from reduced reliance on on-site infrastructure and a more scalable approach to insulin management.

The software is designed to help healthcare providers deliver personalised insulin dosing while supporting glycaemic safety. 

Previous use of the EndoTool platform has been associated with improved blood glucose management, including reduced hypoglycaemia, faster achievement of target glucose levels and fewer blood glucose checks.

The development follows Glooko’s acquisition of Monarch Medical Technologies in 2025. The company plans to support existing EndoTool IV users during the transition and will provide guidance and training as the cloud-based platform becomes available.

EndoTool IV Cloud is expected to be launched commercially in the United States before the end of the year.