Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral neuromodulation therapy with Medtronic’s Interstim system.

Axonics Inc. received FDA approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for bladder and bowel dysfunction. The F15’s primary cell requires no recharging or replacement for more than 15 years with normal use or 20 years at lower energy settings and the system is compatible with 1.5T and 3.0T full body magnetic resonance imaging scans.

The FDA has approved Medtronic plc’s next-generation sacral neuromodulation (SNM) system, Interstim X, giving patients a recharge-free option with a 10-year+ lifespan. This newest member of the Interstim portfolio joins the rechargeable Interstim Micro as a treatment for overactive bladder (OAB), chronic fecal incontinence (FI) and nonobstructive urinary retention.

Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.

Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)