Renovia, ObvioHealth Conclude Fully Virtual Medical Device Trial in Urogynaecology

Virtual Research Organisation (VRO) ObvioHealth may have completed the first ever fully virtual urogynaecology study, in the form of a medical device clinical trial of Renovia’s digital intravaginal device Leva for female stress urinary incontinence. Urinary incontinence is unintentional passing of urine, which affects one in four women, particularly 75% of women above the age 65 reporting urine leakage. Pelvic floor muscle training (PMFT), commonly known as Kegels, is the standard among noninvasive approaches for urinary incontinence. However, 75% of women perform the exercises incorrectly by engaging wrong muscle groups or following a wrong routine. Leva is designed to help users how to preform Kegels more effectively. Read more.

Source: Clinical Trials Arena, March 17, 2022

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