Glooko Receives FDA 510(k) Clearance for EndoTool IV Cloud Platform
Glooko, Inc., a global digital health company specializing in diabetes management and glycemic safety solutions, has announced that the U.S. Food and Drug Administration has granted 510(k) clearance for EndoTool IV Cloud, marking the first FDA-cleared cloud-based patient-specific insulin dosing platform for hospital use. The regulatory milestone represents a major advancement in hospital diabetes care and reflects the growing role of cloud-connected clinical decision support technologies in modern healthcare systems.
EndoTool IV Cloud is the cloud-based evolution of EndoTool IV, Glooko’s established intravenous insulin dosing platform used by hospitals to help clinicians manage hospitalized patients requiring IV insulin therapy. The newly cleared solution maintains the same clinically validated insulin dosing algorithm that healthcare providers have relied on in traditional on-premise deployments, while introducing a cloud-enabled infrastructure designed to support scalability, centralized management, streamlined updates, and future innovation.
The FDA clearance is a significant achievement not only for Glooko but also for the broader digital health industry, as hospitals increasingly seek technology solutions capable of improving patient safety, operational efficiency, and individualized treatment approaches. Cloud-based healthcare technologies have become a major area of investment across the healthcare ecosystem, particularly as providers continue modernizing infrastructure and adopting more connected care models.
According to Mike Alvarez, the FDA’s decision marks an important moment for the company’s long-term strategy to connect diabetes care across inpatient and outpatient settings. Alvarez stated that EndoTool IV has already established itself as a trusted platform for inpatient insulin dosing, and transitioning the technology into a cloud-based environment creates opportunities to improve how hospitals deploy and scale glycemic management programs.
He emphasized that the launch of EndoTool IV Cloud is not simply a technology migration to cloud infrastructure, but rather an effort to help establish a new standard for individualized insulin management and glycemic safety in hospitals. The company believes cloud-based deployment can significantly improve accessibility, operational flexibility, and long-term innovation opportunities for healthcare systems managing large populations of patients with diabetes or acute glycemic instability.
Intravenous insulin therapy is commonly used in hospitals for critically ill patients, surgical patients, and individuals experiencing severe hyperglycemia or other metabolic complications. Maintaining appropriate blood glucose levels in these settings is often challenging, requiring continuous monitoring and individualized dosing adjustments to reduce the risk of complications such as hypoglycemia or uncontrolled hyperglycemia.
Clinical decision support platforms like EndoTool IV are designed to assist healthcare providers by using patient-specific data and advanced insulin dosing algorithms to recommend insulin adjustments tailored to individual needs. Hospitals increasingly rely on such systems to improve consistency in insulin management while reducing variability in care.
EndoTool IV Cloud continues to use the same core insulin dosing algorithm that underpins the current EndoTool IV platform. However, the cloud-based architecture introduces several operational and technical advantages that may help hospitals improve implementation and maintenance processes over time.
Among the key anticipated benefits of the cloud-based platform are centralized software updates, reduced dependence on local server infrastructure, improved deployment flexibility, and more scalable system management. Traditional on-premise healthcare software often requires significant IT resources and hardware investments, while cloud-based models can reduce administrative complexity and simplify future upgrades.
The shift toward cloud-enabled healthcare platforms has accelerated across the industry in recent years as providers seek solutions capable of supporting larger networks, multiple facilities, and increasingly data-driven care environments. Cloud technologies are also viewed as important enablers for future interoperability, analytics integration, and remote management capabilities.
Paul Chidester highlighted the clinical value that EndoTool has already demonstrated in hospital settings. According to Chidester, the platform has been associated with several important clinical improvements, including reductions in hypoglycemia events, faster achievement of target blood glucose levels, improved time in target range, and fewer required blood glucose checks for hospitalized patients.
These clinical outcomes are particularly significant because poor glycemic control in hospitals is associated with increased risks of infection, longer hospital stays, higher treatment costs, and poorer overall outcomes. Healthcare systems continue to prioritize technologies that can help standardize glycemic management while reducing burdens on nursing staff and clinicians.
Chidester noted that EndoTool IV Cloud preserves the same trusted insulin dosing foundation while making the system easier for hospitals to deploy, maintain, and scale. By retaining the validated dosing algorithm while modernizing infrastructure delivery, Glooko aims to provide continuity for current users while improving operational efficiency for healthcare organizations.
The FDA clearance also reflects Glooko’s broader strategic expansion into inpatient diabetes management. Historically recognized for outpatient diabetes data management and remote patient monitoring solutions, the company has increasingly expanded its footprint across the full continuum of diabetes care.
A major step in that expansion occurred in September 2025 when Glooko acquired Monarch Medical Technologies, the original developer of the EndoTool platform. The acquisition strengthened Glooko’s position in the inpatient glycemic management market and expanded its capabilities in hospital-based insulin dosing technologies.
Since completing the acquisition, Glooko has continued investing in the EndoTool platform to support innovation, modernization, and broader integration opportunities across healthcare systems. The launch of EndoTool IV Cloud is viewed as one of the first major outcomes of that investment strategy.
As the company prepares for commercial launch later this year, Glooko stated that it is working closely with hospitals and healthcare teams currently using on-premise versions of EndoTool IV to ensure a smooth transition process. Existing users of the platform will continue receiving support, while the company plans to provide training, migration guidance, and transition resources as healthcare systems evaluate adoption of the cloud-based version.
Rich Glenn described EndoTool IV Cloud as the next stage in the evolution of Glooko’s inpatient insulin dosing platform. Glenn explained that the transition to cloud infrastructure is intended to give hospitals a more scalable and efficient framework for deploying and managing glycemic management solutions across health systems.
He added that the company’s immediate focus is on ensuring a thoughtful customer experience during commercialization while also building a stronger technological foundation capable of supporting future innovation. The cloud environment may eventually enable expanded integration opportunities, more sophisticated analytics, and additional clinical workflow enhancements.
The introduction of cloud-based insulin dosing technology comes at a time when hospitals face increasing pressure to improve operational efficiency while enhancing patient safety outcomes. Diabetes prevalence continues to rise globally, and healthcare providers are managing growing numbers of hospitalized patients with diabetes or stress-related hyperglycemia.
At the same time, hospitals are increasingly investing in digital transformation initiatives aimed at improving clinical workflows, reducing administrative burdens, and leveraging data-driven decision support tools. Technologies that combine automation, predictive analytics, and personalized treatment support are becoming increasingly important components of modern healthcare delivery.
The FDA’s clearance of EndoTool IV Cloud may also signal broader regulatory acceptance of cloud-based clinical decision support technologies in critical care environments. As healthcare software platforms evolve toward more connected and interoperable ecosystems, cloud-enabled solutions are expected to play a larger role in both inpatient and outpatient disease management.
For Glooko, the regulatory approval reinforces its ambition to become a more comprehensive diabetes management platform spanning home care, ambulatory settings, and acute hospital care. By integrating inpatient glycemic management with broader connected diabetes care capabilities, the company aims to support more continuous and coordinated patient management across the healthcare continuum.
EndoTool IV Cloud is expected to launch commercially in the United States before the end of the year, further expanding Glooko’s portfolio of digital health solutions designed to improve diabetes care, glycemic safety, and clinical decision-making for healthcare providers and patients alike.
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.
