FDA Clears Glooko's EndoTool IV Cloud for Hospital Intravenous Insulin Dosing

Glooko said on May 14 that the U.S. Food and Drug Administration has granted 510(k) clearance for EndoTool IV Cloud, a cloud-based version of its software that recommends intravenous insulin doses for hospitalized patients, according to the company's press release. The company described it as "the first FDA-cleared, cloud-based patient-specific insulin dosing platform."

EndoTool IV is a clinical decision support tool that uses patient-specific data to recommend insulin dosing adjustments for patients on IV insulin therapy. Glooko said the cloud product "uses the same core insulin dosing algorithm as the current EndoTool IV solution" and adds cloud functionality intended to support faster deployment, centralized updates and less need for on-premise hardware at hospitals.

What the clearance covers

The release did not give the 510(k) number or the indications for use for the cloud version. EndoTool is an FDA-cleared Class II device indicated for inpatient use, according to Glooko, and its recommendations are intended to assist, not replace, clinical judgment.

HCPLive noted that a 510(k) clearance means the FDA found the device substantially equivalent to a legally marketed predicate, rather than establishing new evidence of clinical superiority, and that the company framed the change mainly as an operational and deployment change. The outlet said evidence supporting the clearance had not yet been released, and listed open questions including the indications wording, changes to electronic health record integration and the product's cybersecurity approach.

"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, medical director for EndoTool at Glooko. HCPLive reported that those cited benefits lacked study-level specifics in the announcement.

Launch and transition plans

Glooko acquired the EndoTool platform when it bought Monarch Medical Technologies in September 2025. EndoTool is developed and marketed by Monarch, now a Glooko company, and is separate from Glooko's outpatient diabetes management platform.

The company said EndoTool IV Cloud is expected to launch commercially in the US before the end of the year. Existing customers of the on-premise EndoTool IV will continue to be supported, and Glooko said it will provide guidance, training and transition resources as the cloud version becomes available.

"By bringing its patient-specific dosing capabilities to a cloud-based platform, we are not just moving to the cloud," said chief executive Mike Alvarez. Rich Glenn, president of connected care, said the company's focus as it prepares for launch is "delivering a thoughtful experience for customers while creating a stronger foundation for long-term innovation and value across health systems."

Glooko did not disclose pricing for the cloud product or how many hospitals currently use EndoTool IV.