Urology ·
FDA clears redesigned OpenFlo urinary catheter; Mannheim team publishes hyperspectral imaging atlas of 17 organs

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The Food and Drug Administration (FDA) cleared Urolution Medical's OpenFlo indwelling urinary catheter, which re-engineers the distal tip and drainage of the conventional Foley catheter, the company said. Researchers in Mannheim published a hyperspectral imaging atlas of 17 human organs from recordings made during 159 urological procedures.
THE DETAILS
- FDA Oct 9, 2026FDA clears Urolution's OpenFlo, a redesigned indwelling urinary catheter, for drainage up to 30 daysThe Food and Drug Administration (FDA) granted 510(k) clearance to Urolution Medical's OpenFlo Urinary Catheter for urinary tract drainage in adults for indwell periods of up to 30 days, the company said. According to Urolution, the catheter re-engineers key mechanical features of the conventional Foley catheter, including the distal tip and drainage configuration. The company said it is preparing clinical studies to compare catheter performance and patient outcomes.Sources: Urolution Medical, Urology Times
- Technology Oct 7, 2026Researchers behind the Mannheim Urology Hyperspectral Imaging Atlas (ManUSPECTRAL) acquired 1095 intraoperative hyperspectral recordings during 159 urological procedures, annotated across 17 organ classes, according to BJU International. Hyperspectral imaging captures information beyond standard red, green and blue light, and the authors said the organs showed distinct and consistent spectral fingerprints. They described the dataset as the first standardized multi-organ hyperspectral reference for human organs and a foundation for future clinical validation of intraoperative tissue characterization.
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