Edgecare’s wearable ultrasound for bladder monitoring wins Korea nod

Korean medtech startup Edgecare said Friday that it has received regulatory clearance from the Ministry of Food and Drug Safety (MFDS) for its wireless wearable bladder monitoring device, the EdgeFlow UW20, clearing the way for commercial rollout and broader clinical use.

The UW20 is designed to detect and manage postoperative urinary retention (POUR), a common complication after surgery that can lead to bladder overdistension, infections, and unnecessary catheterizations.

According to Edgecare, the device uses deep learning-based ultrasound analysis to continuously monitor bladder volume for up to 72 hours with a single attachment.

Traditional methods typically involve intermittent bladder checks every few hours. In contrast, Edgecare says UW20 offers real-time, hands-free monitoring and integrates with a mobile app that logs bladder volume trends, fluid intake, incontinence symptoms, and urinary urgency. The system also generates a digital voiding diary to help clinicians assess patient recovery more effectively.

Edgecare says the device may help reduce catheter-associated urinary tract infections (CAUTIs) by enabling early detection of POUR and minimizing unnecessary catheterizations. Its input-output tracking feature can also support clinicians in identifying signs of dehydration, internal bleeding, or other post-surgical complications.

“There is a growing demand across various clinical settings—general wards, ICUs, long-term care, and rehabilitation hospitals—for continuous bladder monitoring,” said CEO Yoo Yang-mo in a statement. “Yet appropriate solutions remain limited. We believe the UW20 addresses these unmet needs by enhancing both patient safety and resource efficiency.”

Edgecare said it will begin clinical trials in collaboration with the Department of Urology at Severance Hospital to validate the device’s safety and effectiveness in real-world settings. The company also plans to expand its use to chronic care applications, including patients with spinal cord injuries, spina bifida, and neurogenic bladder conditions.