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FDA Grants 510(k) Clearance for Glooko’s EndoTool IV Cloud Insulin Dosing Platform

by Fred Pennic 05/15/2026 Leave a Comment

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FDA Grants 510(k) Clearance for Glooko’s EndoTool IV Cloud Insulin Dosing Platform

What You Should Know

  • Glooko has received U.S. FDA 510(k) clearance for EndoTool IV Cloud, making it the first cloud-based, patient-specific insulin dosing platform cleared for hospital use.
  • The system is the cloud-native evolution of EndoTool IV, a clinical decision support solution used to manage intravenous (IV) insulin therapy for hospitalized patients.
  • The cloud architecture is designed to reduce on-premise infrastructure requirements, streamline maintenance, and support centralized updates across health systems.
  • Clinical benefits of the underlying EndoTool algorithm include reduced hypoglycemia, faster time to target blood glucose, and improved time in range.
  • The launch is expected in the U.S. before the end of 2026, following Glooko’s September 2025 acquisition of Monarch Medical Technologies.

Managing glycemic safety in the acute care environment is a high-stakes clinical challenge. Hospitalized patients requiring IV insulin therapy often face risks of severe hypoglycemia or prolonged hyperglycemia if dosing is not precisely tailored to their changing physiology. Glooko is addressing this complexity by transitioning its proven dosing capabilities to the cloud, allowing hospitals to scale individualized care more efficiently than with legacy on-premise hardware.

Mike Alvarez, CEO of Glooko, noted that this clearance sets a new standard for how hospitals can scale glycemic safety while moving toward a more flexible, connected diabetes care model.

Preserving Clinical Rigor with Operational Agility

EndoTool IV Cloud maintains the same core insulin dosing algorithm as its on-premise predecessor, ensuring that the clinical outcomes trusted by providers are preserved during the transition to the cloud.

  • Reduced Patient Risk: The platform helps clinicians achieve faster stability in blood glucose levels with fewer required checks.
  • Infrastructure De-escalation: By removing the need for local server maintenance, IT teams can deploy the solution more rapidly across multiple sites.
  • Long-Term Innovation: The cloud-based architecture provides a foundation for future AI-driven updates and platform flexibility.

Paul Chidester, M.D., Medical Director for EndoTool, emphasized that the shift is about making a life-saving clinical tool “easier to deploy, maintain and scale” for overstretched hospital teams.

Strategic Continuity Following Acquisition

The development of EndoTool IV Cloud reflects Glooko’s continued investment in the platform after acquiring Monarch Medical Technologies in late 2025. Glooko has committed to supporting current on-premise users through a thoughtful transition strategy, providing training and resources as the cloud version becomes commercially available later this year.

This move reinforces Glooko’s position as a dominant enterprise partner for providers managing diabetes across both the inpatient and outpatient settings.

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