women exercising

FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females.  Read more.

Source: Business Wire, November 13, 2018

product approval

URO-1’s Repris System for Injecting Botox Into Bladder

URO-1, based in Winston-Salem, North Carolina, got FDA approval for its Repris Bladder Injection System. The product is designed for delivering Botox injections into the bladder as a treatment option for overactive bladder. The device, which is supposed to make such procedures easier on the physicians and more comfortable on the patients, will be unveiled at the American Urological Association in San Francisco later this month. Read more.

Source: Medgadget, May 9, 20218

Health Canada logo

Axonics Sacral Neuromodulation System Receives Marketing Approval

Axonics Modulation Technologies, Inc. announced today that it received a Homologation d’un instrument médical (medical device approval) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.  The Health Canada license confirms that the Axonics® product meets all of the Canadian Medical Devices Regulations, Section 36, for Active Implantable Medical Devices and enables Axonics to market its r-SNM System throughout Canada. Read more.

Source: Yahoo! Finance, January 5, 2017