Glooko announced today that the FDA granted 510(k) clearance for its EndoTool IV Cloud, a cloud-based, patient-specific insulin dosing platform.
Palo Alto, California-based Glooko describes the EndoTool IV Cloud as the first FDA-cleared platform of its kind. The cloud-based version of EndoTool IV, it offers a clinical decision support solution for intravenous insulin dosing in the hospital setting. It delivers proven insulin dosing capabilities in a cloud-based environment. The company said this supports more scalable implementation, streamlined maintenance and future platform innovation.
EndoTool IV Cloud uses the same core dosing algorithm as its predecessor while introducing cloud-based functionality that is expected to support more efficient deployment, centralized updates, and a more flexible platform architecture over time. The company hopes the new model reduces the need for on premises infrastructure and supports a more scalable appraoch.
Glooko added EndoTool to its portfolio of diabetes management technologies when it acquired Monarch Medical last year. It says the latest FDA clearance marks an important milestone as it looks to advance connected diabetes care across various settings.
EndoTool IV Cloud is expected to launch commercially in the U.S. before the end of the year.
Commentary from Glooko officials
Mike Alvarez, Glooko CEO, said:
“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. 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.”
Dr. Paul Chidester, medical director, EndoTool at Glooko, said:
“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. 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.”
Rich Glenn, president, Connected Care at Glooko, said:
“EndoTool IV Cloud represents the next evolution of our inpatient insulin dosing platform. 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.”
