product approval introduction

FDA Grants Breakthrough Device Designation to leva System for Chronic Fecal Incontinence

The FDA has granted a breakthrough device designation to the leva Digital Therapeutic System for use as a first-line treatment in women with chronic fecal incontinence (FI) in women, according to Renovia, the developer of the device. The breakthrough device designation will expedite the development and regulatory review of this treatment system in female patients with FI. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device. Read more.

Source: Urology Times, November 1, 2021