Renovia Earns 510(k) Clearance for Urinary Incontinence Treatment

Renovia has received 510(k) clearance from the FDA for its Ieva Pelvic Digital Therapeutic, a device used to strengthen the pelvic floor muscles and treat mild to moderate urinary incontinence in women.

The device offers real-time feedback to women performing pelvic floor muscle exercises by using a movement-based sensor.

The company plans to publish the results of its recently completed multi-center trial “in the coming months,” noting that the study found statistically better results for users of the UI treatment. A larger multi-center trial is planned to kick off in the first half of 2020, Renovia said.