FDA Clears EndoTool IV Cloud for Inpatient IV Insulin Dosing Support

On May 14, 2026, the US Food and Drug Administration (FDA) cleared the EndoTool IV Cloud, a cloud-based version of parent company Glooko’s inpatient intravenous insulin dosing decision-support platform, through the 510(k) pathway.1

According to the company, the newly cleared product uses the same insulin-dosing algorithm as the existing EndoTool IV system and is expected to launch commercially in the US before the end of 2026.1

“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,” Paul Chidester, MD, medical director of EndoTool at Glooko, said in a statement. “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.”1

FDA 510(k) clearance covers a cloud-based EndoTool IV

The EndoTool IV is an FDA-cleared class II clinical decision-support device intended to assist individualized intravenous insulin dosing in hospitalized patients, according to the company. EndoTool IV Cloud is a cloud-based version of the same platform, built around the existing patient-specific insulin dosing algorithm used in the current on-premise product. The company framed the update primarily as an operational and deployment change, citing reduced need for on-premise infrastructure, centralized software updates, and potentially broader scalability across health systems.1

A 510(k) clearance indicates the FDA found a device substantially equivalent to a legally marketed predicate, rather than establishing de novo evidence of clinical superiority. Evidence to support this finding has yet to be released; currently, Glooko describes the tool as having more flexible platform architecture.1

Inpatient glycemic management context and next steps for hospitals

Hospital glycemic management remains operationally complex, particularly for patients receiving IV insulin who require frequent monitoring and rapid dose adjustment. Clinical decision-support platforms have been developed in part to standardize insulin titration and reduce variability in protocol execution, but performance can depend heavily on nursing workflow, patient selection, institutional targets, and local informatics support. In that context, a move from on-premise software to a cloud-based model may interest health systems seeking centralized maintenance and version control, although those advantages are distinct from demonstrated clinical benefit.2

According to the release, Glooko will provide training, guidance, and transition resources as the EndoTool IV Cloud becomes available. In the meantime, existing EndoTool IV customers will continue to receive support. For now, the clearance marks a regulatory milestone for a software deployment model in inpatient diabetes technology, with the clinical significance likely to depend on implementation details and any further evidence the company or independent investigators release.1

“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,” Rich Glenn, president of Connected Care at Glooko, said in a statement. “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.”1

References

1. Glooko Announces FDA 510(k) Clearance for EndoTool IV Cloud. Business Wire. Published May 14, 2026. Accessed May 14, 2026. https://www.businesswire.com/news/home/20260514542969/en/Glooko-Announces-FDA-510k-Clearance-for-EndoTool-IV-Cloud

2. American Diabetes Association Professional Practice Committee. 16. Diabetes Bajaj M, McCoy RG, Balapattabi K, et al. 16. diabetes care in the hospital: Standards of care in diabetes—2026. Diabetes Care. 2025;49(Supplement_1). doi:10.2337/dc26-s016