Jun.2024 11
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MacroLux receives FDA clearance for Single-Use Digital Flexible Cystoscope in the US (no. 4)
Introduction
MacroLux is proud to introduce urologists to their innovative single-use cystoscope, offering a seamless workflow and potential productivity advantages. The BubbleViewTM Single-Use Digital Flexible Cystoscope received 510(k) clearance from the U.S. Food and Drug Administration on June 10, 2024, and is now ready for launch in North America.
Details


We strongly believe that a single-use cystoscope empowers urologists to efficiently manage their schedules and enhance productivity. Unlike reusable cystoscopes, our single-use solution ensures consistent image quality and optimal flexibility without concerns of deterioration over time.

 

Simplified Workflow, Higher Efficiency

With the BubbleViewTM being single-use, doctors will have a brand-new scope for every procedure, eliminating the risk of cross-contamination and the need for reprocessing. This not only reduces healthcare costs associated with cleaning supplies, maintenance, and repairs but also minimizes staff exposure to reprocessing chemicals.

Moreover, the BubbleViewTM can be seamlessly integrated with MacroLux's cutting-edge monitor platform, the ViewHub® S13 Video Processor. Its portability makes it convenient for doctors to perform in-house consultations.

 

Refined Design, Superior Diagnosis

Ensuring smooth maneuverability and navigation within the urethra and bladder is of paramount importance for urologists. In light of this, we have meticulously designed the BubbleViewTM with an Easetip bullet-shaped distal end and segmented firmness, facilitating easy insertion and enhancing patient comfort. The instrument's remarkable bending angles of up to 235 degrees, coupled with flexibility down to 145 degrees, further enhance its effectiveness. Additionally, the high-definition imagery with a million pixels rivals that of reusable cystoscopes, enabling doctors to address a wide range of diagnostic requirements with confidence.

 

ABOUT US

MacroLux is a company dedicated to endoscopic diagnosis and treatment, focused on providing innovative and reliable medical solutions to healthcare professionals around the world. We are focusing on the endoscopic intervention therapy market and prioritize the development of single-use electronic endoscope products.