Hygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes.
The Michigan-based company touted its product as the first insulin management mobile app that can titrate individualized doses for all types of insulin regimens.
It’s also the first insulin-dosing app that can connect to any cloud-connected glucose meter, according to Hygieia.
“This FDA clearance is an important milestone in our mission to improve and simplify insulin management by making the d-Nav Service as convenient, simple and accessible as possible for patients and physicians who could benefit from it,” CEO Eran Bashan said in prepared remarks.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav Service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive and less costly for everyone involved,” Bashan added.
The company’s d-Nav Insulin Guidance System uses algorithms and users’ blood glucose data to provide personalized insulin adjustments.
Hygieia reported today that its system has been offered in Northern Ireland for more than six years and is available in the U.S. via Blue Cross Blue Shield of Michigan.
