Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
LIVONIA, Mich., Feb. 20, 2019 /PRNewswire/ -- Hygieia, a digital insulin enhancement company dedicated to making insulin therapy easier and more effective for everyone involved, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a phone app that will further enhance the company's d-Nav® Insulin Guidance Service. The app is cleared for use as an aid in optimizing insulin management among people with Type 2 diabetes. It is the first insulin-management phone app able to titrate individualized doses for all types of insulin regimens, delivering recommendations directly to the patient. It is also the first insulin-titration app that can connect to any glucose meter that shares data with the cloud. It is available for both iOS and Android mobile phones.
"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," said Eran Bashan, Hygieia CEO. "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 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."
The d-Nav Insulin Guidance Service combines smart cloud-based technology and a small team of healthcare professionals to support primary care physicians and help people with diabetes achieve improved health through better glycemic control. Using proprietary insulin-titration algorithms and patients' individual blood glucose readings, the d-Nav Service provides personalized insulin adjustments to enhance and simplify dosing. Patients utilizing the Service can use the phone app to enter glucose event data and receive a recommended insulin dose. d-Nav has demonstrated the ability to help patients attain and sustain hemoglobin A1c (HbA1c) reductions for at least six years while generating substantial cost savings.
The d-Nav Service has been in use for more than six years in Northern Ireland, and is currently being offered in the United States by Blue Cross Blue Shield of Michigan (BCBSM). It is available at no cost and with no co-pays to BCBSM members with Type 2 diabetes in its fully insured commercial plans, starting with at-risk populations in Southeast Michigan. BCBSM and Hygieia are exploring opportunities to make the d-Nav Service available to other populations and markets in the near future.
About Hygieia
Hygieia is a digital insulin enhancement company dedicated to making insulin therapy easier and more effective for everyone involved. The company is based in Livonia, Mich. and has a wholly owned subsidiary in Northern Ireland. More information is available at www.hygieia.com
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Michele Parisi
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SOURCE Hygieia
