Glooko Wins FDA Nod for EndoTool IV Cloud

Glooko revealed that the U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance for its EndoTool IV Cloud, which is marketed as the first FDA-cleared, cloud-based, patient-specific insulin dosing platform.

The solution is the cloud-based configuration of EndoTool IV, Glooko’s clinical decision support solution for intravenous insulin dosing in the hospital setting. It’s used to support individualized insulin dosing for hospitalized patients needing intravenous insulin therapy.

The tool brings the solution’s insulin dosing capabilities into a cloud-based environment to support more scalable implementation, streamlined maintenance, and future platform innovation. The company said the clearance is an important milestone in its strategy to advance connected diabetes care across inpatient and outpatient settings.

It leverages the same core insulin dosing algorithm as the current EndoTool IV solution and introduced cloud-based functionality. This is expected to support more efficient deployment, centralized updates, and a more flexible platform architecture over time.

The cloud-based model was engineered to reduce the need for on-premise infrastructure and support a more scalable approach for hospitals adopting or expanding EndoTool IV’s use.

“FDA 510(k) clearance for EndoTool IV Cloud is an important step forward for Glooko, our hospital customers, and the future of connected diabetes care,” said Mike Alvarez, CEO of Glooko. “EndoTool IV is already a trusted solution for inpatient insulin dosing. By bringing its patient-specific dosing capabilities to a cloud-based platform, we are not just moving to the cloud—we are helping set a new standard for how hospitals scale glycemic safety and individualized care.”

The availability of this solution reflects the company’s investment in the EndoTool platform after its acquisition of Monarch Medical Technologies in September 2025. As Glooko prepares for launch, it’s working with its teams and customers to support a thoughtful transition strategy for current EndoTool IV on-premise users.

It is anticipated to launch commercially in the U.S. before the end of the year.

“EndoTool IV Cloud represents the next evolution of our inpatient insulin dosing platform,” said Rich Glenn, president, Connected Care at Glooko. “With this milestone, we are advancing EndoTool IV into a cloud-based environment designed to give hospitals a more scalable, flexible, and efficient way to deploy and manage the solution. As we prepare for commercial launch later this year, our focus is on delivering a thoughtful experience for customers while creating a stronger foundation for long-term innovation and value across health systems.”