Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.
The cloud-based service leverages proprietary algorithms, users’ individual blood glucose data and a small team of in-house health professionals to generate and deliver insulin dosage...
Following in the footsteps of Eli Lilly and Roche, Sanofi has quietly received FDA clearance for a smartphone app with a built-in insulin dose calculator. According to FDA documents, the app, cleared at the end of March, is called My Dose Coach. A pending trademark application gives a more in-depth description of the app, describing it as "downloadable software in the nature of a mobile...
