FDA clears BlueWind Medical’s enhanced wearable for urgency urinary incontinence therapy

BlueWind Medical Ltd. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for an enhanced version of its Revi wearable, a device designed to support long-term symptom relief for patients with urgency urinary incontinence.

The clearance applies to an updated wearable component of the Revi System, which the company said is designed to “deliver therapy more effectively and seamlessly support long-term symptom relief for patients.” The system is based on implantable tibial neuromodulation, a therapy approach BlueWind said it has been advancing for more than a decade.

“Since 2010, BlueWind has pioneered and advanced iTNM for UUI, evolving it from an early concept into a well-established therapeutic option supported by a strong body of clinical evidence,” the company said in a statement. It said the latest clearance “further solidifies the company’s mission to meet the needs of people with UUI to help them live their best lives.”

The updated Revi wearable features what the company described as “a streamlined, easy-to-use design with a smarter, user-friendly interface,” while maintaining “the same simple, three-button control.” The enhancements are intended to give patients “greater confidence, control, and convenience in managing their UUI,” the company said.

According to the company, clinical data show that 79% of patients using the system achieved at least a 50% reduction in urgency urinary incontinence episodes, while 97% of patients reported satisfaction with the therapy. The company also cited an “excellent safety profile,” reporting no device- or procedure-related serious adverse events, no device migrations and no device revision procedures. The system is implanted in a single, minimally invasive procedure performed under local anesthesia and does not require a trial phase, the company said.

“We are proud to lead the next generation of technology for the treatment of urgency urinary incontinence,” said Kerry Nelson, CEO of BlueWind Medical. “Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve.”

Nelson said the enhanced wearable “continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use,” adding, “All of this helps patients achieve durable symptom relief and overall satisfaction.”

Recent advances in neuromodulation for bladder control

Advances in neuromodulation have reshaped treatment options for patients with urgency urinary incontinence and other bladder control disorders, offering alternatives to medications and more invasive surgical procedures. Over the past decade, research has focused on refining how electrical stimulation is delivered, improving patient comfort, and enabling longer-term symptom management with fewer side effects.

One major trend has been the move toward targeted peripheral nerve stimulation, including approaches that modulate signals traveling between the bladder and the brain. By focusing on specific nerve pathways, these therapies aim to restore normal bladder signaling without affecting surrounding tissues. Improvements in electrode design and placement have contributed to more consistent stimulation and reduced complications.

Miniaturization has also played a key role. Implantable components are now smaller and designed to be placed using minimally invasive techniques, often under local anesthesia. This has lowered procedural risk and expanded the pool of patients who may be candidates for neuromodulation-based therapies. At the same time, wearable and external controllers have become more intuitive, allowing patients to adjust therapy parameters as symptoms change.

Another area of progress has been personalization. Modern systems increasingly allow therapy to be adjusted over time, recognizing that urinary symptoms can fluctuate due to age, activity level, and comorbid conditions. This adaptability is supported by growing clinical evidence showing that patient engagement and control are closely linked to long-term adherence and satisfaction.

Safety and durability remain central concerns, and recent studies have emphasized long-term follow-up data, tracking device stability, adverse events, and sustained symptom relief over multiple years. Regulators and clinicians alike have placed greater emphasis on real-world outcomes, including quality of life and patient-reported measures.

Together, these advances signal a broader shift toward chronic-condition management tools that blend implantable technology with user-friendly external components, aiming to provide durable relief while fitting more naturally into patients’ daily lives.