PALO ALTO, Calif. — Glooko said the U.S. Food and Drug Administration has granted 510(k) clearance for EndoTool IV Cloud, a cloud-based insulin dosing platform designed for use in hospitalized patients who require intravenous insulin therapy.
The Palo Alto digital health company said EndoTool IV Cloud is the first FDA-cleared, cloud-based patient-specific insulin dosing platform. The product is a cloud-based version of EndoTool IV, Glooko’s clinical decision support system for intravenous insulin dosing in hospitals.
Glooko said the platform uses the same core insulin dosing algorithm as the existing EndoTool IV product, while adding cloud-based functionality intended to make deployment, maintenance and updates easier for hospital teams. The company said the cloud model is also designed to reduce the need for on-premise infrastructure and support broader adoption across health systems.
“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, Chief Executive Officer 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.”
EndoTool IV is used by hospitals to support individualized insulin dosing for patients requiring IV insulin therapy. Glooko said the cloud-based version keeps the same clinical foundation while creating a more scalable platform for future development.
“EndoTool has demonstrated strong clinical value in helping hospitals manage IV insulin therapy, including reduced hypoglycemia, faster time to target blood glucose, improved time in range, and fewer required blood glucose checks,” said Paul Chidester, M.D., Medical Director, EndoTool at Glooko. “With EndoTool IV Cloud, we are preserving the same trusted clinical foundation and insulin dosing algorithm while making the solution easier to deploy, maintain and scale for hospital teams.”
The clearance follows Glooko’s acquisition of Monarch Medical Technologies in September 2025 and reflects the company’s continued investment in the EndoTool platform.
Glooko said existing EndoTool IV customers will continue to be supported as the company prepares for the commercial launch of EndoTool IV Cloud. The company said it will provide guidance, training and transition resources for current on-premise users.
“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.”
Glooko expects to launch EndoTool IV Cloud commercially in the U.S. before the end of 2026.
