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

business buildings

Stewartville Plant Creates New Solution to an Old Problem

Automated machines quietly raise and lower trays of liquid silicone, water and a paraffin-like material in a Stewartville facility to create a new solution to an age-old medical condition that afflicts an estimated 2 percent of the world’s population. Multiple, carefully monitored dips create trays of 400 silicone inserts with a small bubble of liquid in four minutes. The inserts then move on to packaging to eventually be shipped to Minnesota Medical Technologies’ waiting customers in a growing number of countries. Designed by and created by a local team led by brothers Jim and Philip Conway, the patented myMiracle device is a small, lubricated anal insert to be used as a simple and discreet way to treat fecal incontinence.  Read more.

Source: Post-Bulletin, Rochester, Minn., August 7, 2021