Zynex gets 510(k) for urinary incontinence device

Colorado's Zynex ($ZYXI) snagged 510(k) clearance for InWave, an electrotherapy device designed to treat urinary incontinence.

The ailment affects about 200 million people around the world, Zynex says, about 80% of whom are women. Zynex CEO Thomas Sandgaard said in a statement that his company has the sales force to make headway into that market, and InWave has already secured insurance reimbursement.

InWave is the latest in Zynex's line of electrotherapy devices to treat pain and muscle ailments, and the company reported a 19% increase in net revenue in the last quarter, pulling in about $10 million. Zynex is looking to expand its nascent diagnostics business, too, marketing the NeuroMove device for stroke and spinal cord injury patients. Back in March, the company acquired NeuroDyne Medical, folding that firm's intellectual property into Zynex Diagnostics.

InWave will be manufactured and marketed in-house through Zynex Medical, the company said, and the company's non-invasive treatment for urinary incontinence may well be a welcome alternative for patients and physicians wary of risky implants. Johnson & Johnson ($JNJ) has been embroiled in lawsuits over its vaginal mesh implant, designed to treat urinary incontinence, with patients claiming serious injuries resulting from the techs.

- read Zynex's release

Like what you're reading?
Click here to get more news delivered to your inbox everyday >>

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.