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Revolutionary Insulin Algorithms' decision-support software for Clinicians receives FDA approval

23 June 2017 | News

It is a comprehensive dosing solution for all patients and all insulin regimens and will drive billions of dollars in healthcare savings.

Singapore - The U.S. Food & Drug Administration has cleared as a Class II medical device Insulin Algorithms' decision-support software, which helps clinicians manage every type of insulin for diabetes treatment. Culminating clinical practice and research led by renowned endocrinologist and former American Diabetes Association (ADA) President Mayer B. Davidson, MD, Insulin Algorithms' software makes it easy for a clinician to regularly analyze a patient's blood sugar measurements and quickly optimize their insulin regimen.

The software is based on algorithms that are clinically proven to lower HbA1c even in challenging patient populations, no matter what insulin regimen they are on. This makes it possible to achieve better health outcomes, save billions of dollars in annual health care spending, and reduce rates of diabetes-related complications. With FDA clearance and its previous CE registration, Insulin Algorithms' decision-support software can now be marketed and sold in both the United States and Europe.

High blood glucose in people with diabetes is the third highest risk factor for premature mortality. Over half of U.S. diabetic patients fail to reach the ADA's recommended HbA1c target, and failure rates in reaching HbA1c targets are higher in other countries. While there is significant industry focus on modifying patients' behavior with apps and self-management of insulin injections, Insulin Algorithms takes a different approach to diabetes care. "Because of the shortage of endocrinologists, 90% of patients see their primary care provider for diabetes care. This results in a six- to seven-year delay in the initiation of insulin and elevated blood sugar levels once patients are prescribed insulin. We designed our software to close this clinical care gap”, said Josh Davidson, CEO of Insulin Algorithms.

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