Glooko Announces FDA 510(k) Clearance for EndoTool IV Cloud

EndoTool IV Cloud is the first FDA-cleared, cloud-based patient-specific insulin dosing platform, designed to support scalable deployment

Commercial launch anticipated before the end of 2026

PALO ALTO, Calif.--(BUSINESS WIRE)--Glooko, Inc., a global digital health company focused on helping clinicians address the growing challenges of glycemic safety and diabetes management across the care continuum, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for EndoTool IV Cloud, the first FDA-cleared, cloud-based patient-specific insulin dosing platform. EndoTool IV Cloud is the cloud-based version of EndoTool IV, Glooko’s clinical decision support solution for intravenous insulin dosing in the hospital setting.

EndoTool IV is used by hospitals to support individualized insulin dosing for hospitalized patients requiring intravenous insulin therapy. Built on the same trusted clinical foundation as EndoTool IV, EndoTool IV Cloud brings the solution’s proven insulin dosing capabilities into a cloud-based environment, supporting more scalable implementation, streamlined maintenance, and future platform innovation.

The clearance marks an important milestone in Glooko’s strategy to advance connected diabetes care across the inpatient and outpatient settings.

“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 Cloud uses the same core insulin dosing algorithm as the current EndoTool IV solution, while introducing cloud-based functionality that is expected to support more efficient deployment, centralized updates, and a more flexible platform architecture over time. The cloud-based model is designed to reduce the need for on-premise infrastructure and support a more scalable approach for hospitals adopting or expanding use of EndoTool IV.

“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 availability of EndoTool IV Cloud reflects Glooko’s continued investment in the EndoTool platform following its acquisition of Monarch Medical Technologies in September 2025. As Glooko prepares for commercial launch, the company is working closely with its teams and customers to support a thoughtful transition strategy for those current EndoTool IV on-premise users. Existing EndoTool IV customers will continue to be supported, and Glooko will provide guidance, training, and transition resources as EndoTool IV Cloud becomes commercially available.

“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.”

EndoTool IV Cloud is expected to launch commercially in the U.S. before the end of the year.

About EndoTool IV

EndoTool IV is a clinical decision support solution designed to support individualized intravenous insulin dosing in the hospital setting. The solution uses patient-specific data to recommend insulin dosing adjustments and help clinicians manage glycemic control for patients requiring IV insulin therapy.

EndoTool IV Cloud brings this capability into a cloud-based environment using the same insulin dosing algorithm as the current EndoTool IV solution.

About Glooko

Glooko, Inc. is a global digital health company focused on helping clinicians address the growing challenges of glycemic safety and diabetes management across the care continuum. Glooko is uniquely positioned to be the enterprise partner of choice for healthcare providers seeking to reduce glycemic risk, improve safety, and support overburdened clinical teams with coordinated expertise across both outpatient and inpatient care settings.

EndoTool is developed and marketed by Monarch Medical Technologies, LLC, a Glooko Company, and is a separate solution from the Glooko diabetes management platform. EndoTool is an FDA-cleared Class II medical device indicated for inpatient use as described in its Instructions for Use. Recommendations are intended to assist, and not replace, clinical judgment.