Fractyl Health Approved for Payment in Germany for Revita DMR System for Diabetes
Lexington, Mass.-based Fractyl Health’s type 2 diabetes treatment device Revita has been approved for reimbursement by hospitals in Germany.
Revita uses heat to resurface the lining of the upper intestine, an organ that plays an important role in metabolic regulation. The treatment is intended to improve glycemic control in patients with inadequately controlled type 2 diabetes who are on antidiabetic agents or long-acting insulin therapy.
Revita received Europe’s CE mark certification in 2016 and last year earned a Breakthrough Device designation from the FDA.