Medical device company Urolution Medical Inc announced on Friday that it has received US Food and Drug Administration (FDA) 510(k) clearance for its OpenFlo Urinary Catheter, advancing the company toward clinical evaluation and commercialisation.

Cleared for urinary tract drainage in adults for indwelling periods of up to 30 days, OpenFlo features patented design changes to key components of conventional Foley catheters, including the distal tip and drainage configuration.

The catheter uses established silicone catheter manufacturing methods, with production costs comparable to conventional all-silicone Foley catheters, supporting scalability without substantial manufacturing cost increases, Urolution Medical said.

Following clearance, Urolution Medical is preparing clinical studies to assess comparative catheter performance and patient outcomes while advancing manufacturing and commercialisation plans.

The company is also pursuing strategic partnerships, additional capital and commercial relationships with established healthcare organisations to support broader market introduction.