Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia.
The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare providers in the first half of 2017.
“This simultaneous regulatory clearance of Insulia, both in the USA and in Europe, is a unique achievement in digital health and the culmination of many years of hard work,” Voluntis Founder and CEO Pierre Leurent said in a statement. “We look forward to working hand in hand with providers and payers, as well as our business partners, to make this innovative solution widely available to patients across the globe.”
Insulia is accessible via web, iOS, Android or a tablet and offers the users dosage recommendations, educational coaching and diabetes-related data. The app can work with a variety of treatment plans and dosage guidelines based on the user’s clinician-prescribed personalized treatment plan, including their insulin prescription and blood glucose targets. Then, Insulia uses a dose-adjusting algorithm to help the user manage their diabetes and work towards their goals, and the data is automatically shared with the health care team (who can also monitor the patient’s progress toward their goal).
Voluntis, which was founded in 2001, places a strong focus on clinical trial validations and making software that is both prescribable and reimburseable, and they don't sell any apps directly to consumers. The company has developed software for diabetes, cancer, anticoagulation treatments and hemophilia. Last year, the company partnered with AstraZeneca to develop an app for women undergoing treatment for ovarian cancer.