FDA grants 510(k) clearance to EdgeFlow UH10 Bladder Scanner

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The EdgeFlow UH10 bladder scanner utilizes high-resolution ultrasound imaging to non-invasively measure postvoid residual urine in the bladder.

The FDA has granted 510(k) clearance to the ultrasound bladder scanner EdgeFlow UH10, announced Edgecare, the developer of the technology, in a news release.1

Edgecare plans to participate in the 2024 American Urological Association Annual Meeting in May.

Edgecare plans to participate in the 2024 American Urological Association Annual Meeting in May.

"This FDA clearance lays the foundation for Edgecare to successfully operate not only within the US but also in other international markets. We are committed to advancing monitoring solutions for escalating health concerns, contributing to the enhancement of human health and quality of life,” said Yangmo Yoo, PhD, CEO and founder of Edgecare, in the news release.1

According to Edgecare, the EdgeFlow UH10 bladder scanner utilizes high-resolution ultrasound imaging to non-invasively measure post-void residual urine in the bladder. The scanner offers a volume measurement range of 0 to 999 mL, with accuracy ± 7.5% with over 100 mL.2

Takeaways

  • EdgeFlow UH10 receives US FDA 510(k) clearance
  • The bladder scanner utilizes high-resolution ultrasound imaging to non-invasively measure bladder volume
  • Edgecare plans to participate in the 2024 AUA Annual Meeting in May

The device is equipped with DualActive probe technology to allow for scanning of the traverse and sagittal planes of the bladder simultaneously with 1 scan. Additionally, the tool incorporates deep learning AI-powered LiveContour and MaxContour technologies in order to quickly identify the bladder and provide fast calculations of accurate measurement values of maximum bladder volume.

The device also offers a lightweight and compact design to enable ease in portability. The total weight of the console and probe is 419 g.

Following the FDA 510(k) clearance, Edgecare plans to increase their sales and marketing initiatives toward US medical institutions. They also plan to further expand their market presence by offering solutions to urinary health-related issues among those in aging populations. 

The EdgeFlow UH10 Bladder Scanner was showcased earlier this year during a presentation at Arab Health 2024 in Dubai, United Arab Emirates, the largest health care exhibition in the Middle East and Africa.3 Edgecare also plans to participate in the 2024 American Urological Association Annual Meeting in San Antonio, Texas in May.

References

1. Edgecare Inc. obtains U.S. FDA clearance for ultrasound bladder scanner EdgeFlow UH10. News release. Edgecare Inc. March 7, 2024. Accessed March 20, 2024. https://www.edgecare.co.kr/bbs/board.php?bo_table=gallery&wr_id=29

2. [Product Brochure] Edgeflow UH10. Edgecare. https://www.edgecare.co.kr/bbs/board.php?bo_table=bladder

3. Edgecare showcases EdgeFlow UH10 Bladder Scanner at Arab Health 2024. News release. Edgecare Inc. February 29, 2024. Accessed March 20, 2024. https://www.edgecare.co.kr/bbs/board.php?bo_table=gallery&wr_id=28

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