[PR] Edgecare’s ‘EdgeFlow UW20’ Earns Certification in South Korea for Postoperative Bladder Monitoring > 갤러리

Edgecare’s ‘EdgeFlow UW20’ Earns Certification in South Korea for Postoperative Bladder Monitoring

Deep learning-powered wireless wearable ultrasound introduces a new paradigm in postoperative patient care

Seoul, South Korea - April 18, 2025 - Postoperative Urinary Retention (POUR) is one of the most common complications following surgery. It occurs when the bladder fails to empty properly, leading to overdistension, potential urological damage, and infections. Without accurate monitoring of voiding patterns, unnecessary indwelling catheterization may be used, increasing patient discomfort and the risk of catheter-associated urinary tract infections (CAUTIs).

Recognizing this critical clinical need, Korean med-tech startup Edgecare (CEO: Yangmo Yoo) has developed EdgeFlow UW20 (hereinafter “UW20”), a wireless wearable bladder monitoring device designed to detect and manage POUR in real-time. The company announced that the device recently received certification as a digital medical device from the Korean Ministry of Food and Drug Safety (MFDS).

The EdgeFlow UW20 is the first wireless wearable bladder monitor utilizing deep learning-based ultrasound imaging analysis to be developed and certified in Korea. Unlike conventional methods that require intermittent manual residual volume measurements every 3 to 6 hours, the UW20 enables continuous bladder volume monitoring for up to 72 hours with a single attachment, allowing clinicians to track a patient’s urinary status from immediately after surgery through discharge.

The UW20 integrates with a mobile application to record and manage comprehensive data including bladder volume trends, urinary urgency, incontinence symptoms, and fluid intake. The system automatically generates a digital voiding diary, empowering clinicians to analyze patients’ voiding patterns and detect abnormalities more effectively.

Importantly, the device helps detect POUR early, enabling timely interventions while avoiding unnecessary catheterizations. This reduces the risk of CAUTIs, mucosal injury, and other catheter-related complications. Additionally, its input-output (I&O) management functionality helps monitor for signs of dehydration, bleeding, or other post-surgical complications, enhancing the overall safety and efficiency of recovery.

With this certification, Edgecare plans to launch the UW20 in the domestic market and accelerate its entry into the global bladder monitoring market. “There is a growing demand across various clinical settings—general wards, ICUs, long-term care, and rehabilitation hospitals—for continuous bladder monitoring,” said CEO Yangmo Yoo. “Yet appropriate solutions remain limited. We believe the UW20 addresses these unmet needs by enhancing both patient safety and resource efficiency.”

Edgecare also announced plans to conduct clinical trials in collaboration with the Department of Urology at Severance Hospital to validate the UW20’s effectiveness and safety in real-world settings. The company aims to expand its application beyond postoperative monitoring to include daily management of patients with chronic urinary conditions such as spinal cord injury, spina bifida, and neurogenic bladder disorders.