The US Food and Drug Administration (FDA) has granted 510(k) clearance for Urolution Medical’s OpenFlo urinary catheter.
Cleared for adult use, the device drains the urinary tract and can remain in place for up to 30 days.
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Following the clearance, Urolution Medical is preparing comparative clinical trials to evaluate the catheter performance and patient outcomes.
The company continues to progress its manufacturing and commercial plans. To support a wider market launch, it is also seeking extra funding, strategic partnerships, and ties with established healthcare organisations.
Urolution Medical co-founder and president Weihao Qu said: “FDA clearance represents the culmination of years of work to rethink one of the most widely used medical devices in patient care.
“OpenFlo was built around a different approach to catheter architecture. With clearance achieved, our focus now shifts to clinical validation, strategic partnerships, and bringing the technology toward commercial use.”
The OpenFlo catheter combines a patented architecture that modifies fundamental mechanical characteristics of conventional Foley catheters, specifically altering the distal tip and drainage configuration.
Commercial scalability served as a core consideration during product development.
The manufacturing process relies on established silicone catheter fabrication techniques, keeping production expenses comparable to standard all-silicone Foley catheters and providing a scalable route to market without substantial cost increases.
Urolution Medical chief medical officer John Adams Jr said: “OpenFlo represents an opportunity to evaluate whether a differentiated catheter design can translate into meaningful improvements in clinical performance. FDA clearance allows us to take that next step through rigorous clinical evaluation.”
Headquartered in the US state of Minnesota, US, Urolution Medical is focused on creating differentiated technologies intended to advance urological care.
