Glooko Announces FDA 510(k) Clearance for EndoTool IV Cloud

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Glooko Announces FDA 510(k) Clearance for EndoTool IV Cloud

2026-05-14 20:04 Last Updated At：20:10

PALO ALTO, Calif.--(BUSINESS WIRE)--May 14, 2026--

Glooko, Inc., a global digital health company focused on helping clinicians address the growing challenges of glycemic safety and diabetes management across the care continuum, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for EndoTool IV Cloud, the first FDA-cleared, cloud-based patient-specific insulin dosing platform. EndoTool IV Cloud is the cloud-based version of EndoTool IV, Glooko’s clinical decision support solution for intravenous insulin dosing in the hospital setting.

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EndoTool IV is used by hospitals to support individualized insulin dosing for hospitalized patients requiring intravenous insulin therapy. Built on the same trusted clinical foundation as EndoTool IV, EndoTool IV Cloud brings the solution’s proven insulin dosing capabilities into a cloud-based environment, supporting more scalable implementation, streamlined maintenance, and future platform innovation.

The clearance marks an important milestone in Glooko’s strategy to advance connected diabetes care across the inpatient and outpatient settings.

“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,” said Mike Alvarez, Chief Executive Officer of Glooko. “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.”

EndoTool IV Cloud uses the same core insulin dosing algorithm as the current EndoTool IV solution, while introducing cloud-based functionality that is expected to support more efficient deployment, centralized updates, and a more flexible platform architecture over time. The cloud-based model is designed to reduce the need for on-premise infrastructure and support a more scalable approach for hospitals adopting or expanding use of EndoTool IV.

“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, M.D., Medical Director, EndoTool at Glooko. “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.”

The availability of EndoTool IV Cloud reflects Glooko’s continued investment in the EndoTool platform following its acquisition of Monarch Medical Technologies in September 2025. As Glooko prepares for commercial launch, the company is working closely with its teams and customers to support a thoughtful transition strategy for those current EndoTool IV on-premise users. Existing EndoTool IV customers will continue to be supported, and Glooko will provide guidance, training, and transition resources as EndoTool IV Cloud becomes commercially available.

“EndoTool IV Cloud represents the next evolution of our inpatient insulin dosing platform,” said Rich Glenn, President, Connected Care at Glooko. “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.”

EndoTool IV Cloud is expected to launch commercially in the U.S. before the end of the year.

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.

EndoTool is developed and marketed by Monarch Medical Technologies, LLC, a Glooko Company, and is a separate solution from the Glooko diabetes management platform. EndoTool is an FDA-cleared Class II medical device indicated for inpatient use as described in its Instructions for Use. Recommendations are intended to assist, and not replace, clinical judgment.

UK health secretary resigns and is expected to challenge Starmer's leadership

LONDON (AP) — Health Secretary Wes Streeting quit embattled British Prime Minister Keir Starmer’s Cabinet Thursday in what is expected to be a precursor to challenging his leadership.

Streeting is the first Cabinet member to resign as Starmer faces pressure to step down after the Labour Party’s disastrous results last week in local and regional elections.

Streeting, whose political ambitions have long been known, is considered one of a handful of people who could try to unseat Starmer.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

LONDON (AP) —

Efforts to unseat British Prime Minister Keir Starmer are likely to break out into open rebellion Thursday, with one potential rival expected to announce his bid for the job and another clearing the way for her to enter any future leadership contest.

Allies of Health Secretary Wes Streeting say he will make an announcement later in the day after garnering enough support from lawmakers of the governing Labour Party to challenge Starmer for leadership of the party and the government.

Former Deputy Prime Minister Angela Rayner said Thursday that she had reached an agreement with tax authorities to clear up questions about her taxes that forced her to leave the Cabinet last September. Rayner told the Guardian newspaper that Starmer should “reflect on” his position, adding that she was ready to “play my part” in any leadership election if Streeting were to trigger a contest.

Pressure for Starmer to step aside has intensified since Labour suffered disastrous losses in local and regional elections last week, underscoring voter frustration with a government that has failed to deliver on pledges to boost economic growth and improve living standards for working people.

Labour “just had a severe beating off the electorate” and everyone in the party recognizes things have to change, Rayner told ITV News, without directly addressing calls for Starmer to resign.

“Some people are saying that, but what I’m saying is the delivery of what we promised the electorate is the most important thing that we need to be concentrating on at the moment. I’m not getting into hypotheticals about leadership at the moment.”

A stagnant economy and stubbornly high consumer price inflation have made it difficult for Starmer’s government to deliver on its promises after winning a landslide election victory less than two years ago.

Starmer has vowed to remain in office, warning lawmakers that any leadership contest would plunge the government into “chaos” at a time it should be focused on issues like the cost of living crisis and war in the Middle East.

His effort to fight off a leadership challenge was bolstered Thursday morning by a rare bit of positive economic news.

Gross domestic product, a broad measure of economic activity, grew 0.6% in the first three months of the year, compared with 0.2% in the previous quarter, the Office for National Statistics said.

Treasury chief Rachel Reeves said the figures showed that her policies were working and that renewed economic growth would allow the government to put more money into public services and programs to support those hit by the high cost of living.

“But that is only possible because of the economic stability that we have brought back to our economy,” she told the BBC. “And we shouldn’t put that at risk by plunging the country in chaos at a time when there is conflict in the world.”

There was also positive news from the National Health Service. Waiting lines for NHS appointments — one of Streeting's signature priorities – had fallen for the fifth straight month, boosting any potential candidacy.

Streeting comes from the moderate wing of the left-leaning Labour Party, as does Starmer. Rayner is a favorite of many more left-wing voters, calling on the party to do more to boost the minimum wage and raise taxes on the rich.

Under Labour Party rules, any potential challenger to the prime minister would have to have the backing of 81 of the party’s 403 members in the House of Commons. More than that number have publicly called on Starmer to quit in recent days.

But other potential candidates may enter any race for the leadership.

Greater Manchester Mayor Andy Burnham has been widely discussed as a potential candidate, though he would have to find a way back into Parliament before he could run. Allies have suggested a sitting member of the House of Commons could resign to make way for Burnham to run in a special election.

Burnham canceled his regular Thursday appearance on a local BBC radio program this week to “prioritize discussions arising from last week’s elections.”