PALO ALTO, Calif., May 14, 2026
Glooko, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for EndoTool IV Cloud, the first FDA-cleared cloud-based patient-specific insulin dosing platform designed for hospitalized patients requiring intravenous insulin therapy. The milestone strengthens Glooko’s growing position in connected diabetes care and hospital glycemic management while introducing a more scalable cloud infrastructure intended to improve deployment efficiency, clinical workflow integration, and long-term healthcare system flexibility.
FDA Clearance Expands Cloud-Based Diabetes Management
EndoTool IV Cloud is the cloud-enabled version of EndoTool IV, Glooko’s established clinical decision support platform used by hospitals for individualized intravenous insulin dosing. The newly cleared cloud platform retains the same insulin dosing algorithm and clinical framework already trusted in inpatient settings while adding cloud-based functionality intended to support streamlined deployment, centralized software updates, and reduced on-premise infrastructure requirements.
The FDA clearance represents a major advancement in the digital transformation of inpatient diabetes care. Hospitals managing critically ill patients often require continuous insulin dosing adjustments to maintain safe blood glucose levels and reduce complications associated with hypoglycemia or hyperglycemia. By moving the EndoTool platform into a cloud environment, Glooko aims to help healthcare providers improve scalability while simplifying ongoing maintenance and operational management.
Mike Alvarez, Chief Executive Officer of Glooko, stated that the FDA clearance marks an important step toward establishing a new standard for scalable glycemic safety and individualized diabetes management in hospitals. He emphasized that the cloud-based architecture is intended not only to modernize deployment but also to strengthen the future of connected diabetes care across healthcare systems.
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EndoTool IV Demonstrates Strong Clinical Performance
According to Glooko, EndoTool IV has already demonstrated meaningful clinical benefits in hospital environments, including reductions in hypoglycemia, faster achievement of target blood glucose levels, improved time-in-range performance, and fewer required blood glucose checks. These clinical improvements are particularly important in intensive care and acute care settings where glucose management plays a critical role in patient outcomes and operational efficiency.
Paul Chidester, M.D., Medical Director for EndoTool at Glooko, noted that EndoTool IV Cloud preserves the same proven insulin dosing algorithm while creating a more flexible and scalable deployment model for hospital systems. The company believes that the cloud transition will simplify implementation for healthcare organizations while maintaining the clinical reliability that hospitals already expect from the platform.
The cloud-based system is also expected to support more efficient enterprise-wide adoption among hospitals seeking to modernize diabetes management technology infrastructure. By reducing the need for extensive local hardware installations, healthcare providers may gain additional operational flexibility while improving access to standardized updates and centralized support.
Glooko Accelerates Connected Care Strategy
The FDA clearance follows Glooko’s acquisition of Monarch Medical Technologies in September 2025, strengthening the company’s connected inpatient and outpatient diabetes care strategy. EndoTool IV Cloud represents a central component of Glooko’s broader vision to integrate glycemic management technologies across healthcare settings while reducing clinical burden for overextended hospital teams.
Rich Glenn, President of Connected Care at Glooko, described EndoTool IV Cloud as the next evolution of the company’s inpatient insulin dosing platform. He stated that the solution is designed to give hospitals a more scalable, efficient, and flexible method for deploying insulin dosing technology while creating a stronger foundation for future innovation across healthcare systems.
Glooko confirmed that the commercial launch of EndoTool IV Cloud is expected in the United States before the end of 2026. Existing EndoTool IV customers will continue receiving support, training, and transition assistance as hospitals prepare to adopt the new cloud-based platform.
The FDA clearance highlights the growing momentum behind cloud-enabled digital health technologies aimed at improving hospital efficiency, patient safety, and individualized diabetes management through advanced clinical decision support systems.
Source: Glooko press release
