Avation Medical Receives the US FDA’s 510(k) Clearance of Vivally System for Urinary Urgency and Urge Urinary Incontinence
Shots:
- The US FDA has granted 510(k) clearance to Vivally system, a patient-friendly, non-invasive, smart wearable bladder control therapy & mobile app for women & men with urinary urgency & UUI
- The system provides a new option for patients to conduct therapy at home without surgery, implants, or drugs. It is easy, comfortable, and takes only 30 minutes as little as once per week & will be available in select geographies in Q2’23
- The (FREEOAB) study results from 96 patients with overactive bladder showed that 69% of patients were responders for urinary urgency @6mos. & 63% for urge incontinence, 50% for symptom improvement or a return to normal. The Vivally system was easy to use for 98% of patients with no significant device-related AEs
Ref: PR Newswire | Image: Avation
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
