Voluntis, a global company that develops therapeutic companion software, which empowers patients to self-manage chronic diseases, has received FDA 510(k) clearance, and CE Mark, for Insulia.
The company claims that its first-in-class global digital solution, Insulia, supports the effective management of type 2 adult diabetes in patients treated with basal insulin.
Voluntis' founder and CEO Pierre Leurent said: “With companion software, we seek to contribute to the transition to value-based care, by improving quality of care and optimizing the cost of managing chronic diseases.
“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.
“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."
About 30 million Americans and 400 million people across the globe have diabetes, and nearly 90% of the individuals have type 2 diabetes and are often treated with basal insulin.
Mayo Clinic Rochester Endocrinologist Ananda Basu said: “Type 2 diabetes is a complex condition, especially for people who have transitioned to insulin therapy.
"Indeed, self-monitoring blood glucose and self-managing insulin doses is cumbersome and challenging for a majority of patients.
“As a result, harnessing new and reliable technologies to support patients in safely managing insulin dosing while keeping in touch with healthcare team could be well received by provider and patient communities.”
Insulia Diabetes Management Companion is a prescription-only medical device, which offers patients with insulin dose recommendations and educational coaching messages in response to blood glucose values and other diabetes-related data.
It supports a wide variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice.
According to the company, Insulia will be available to patients and healthcare providers in the first half of next year.
Image: Voluntis obtains clearnce from FDA for Insulia. Photo: courtesy of Voluntis.