Insulia receives FDA 510(k) clearance

Voluntis' Insulia recently received FDA 510(k) clearance.
Voluntis' Insulia recently received FDA 510(k) clearance. | File photo
Voluntis has received FDA 510(k) clearance for Insulia, which also received the CE Mark for the treatment of Type 2 diabetes in adult patients that have had previous basal insulin treatments.
"Type 2 diabetes is a complex condition, especially for people who have transitioned to insulin therapy," Mayo Clinic (Rochester) Endocrinologist Dr. Ananda Basu said. "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."
Approximately 30 million individuals in the U.S. and 400 million individuals on a global scale have diabetes, which is a chronic condition that is associated with high blood sugar levels caused by an inappropriate production or the use of insulin.
"To make a meaningful impact on patients' daily lives as well as clinical outcomes, we need to use intelligent digital solutions that go beyond data sharing between patients and clinicians,” CERITID President Dr. Guillaume Charpentier said.
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Voluntis 1 Broadway Cambridge, MA - 02142