Aug.2024 19
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MacroLux receives FDA clearance for Single-Use Digital Hystroscope in the US (no. 5)

Introduction
We are thrilled to announce that our disposable hysteroscope SeleneView® has obtained the 510(k) clearance from the U.S. Food and Drug Administration (FDA), marking a momentous milestone for us.
Details


Committed to providing cutting-edge medical solutions that prioritize patient comfort and surgical success, the innovative SeleneView® is poised to revolutionize hysteroscopic procedures, offering numerous benefits to patients and healthcare providers.

 

Unmatched Slimness

Our SeleneView® single-use hysteroscope employs a finer endoscope, enabling surgeries without the need for cervical dilation or anesthesia, effectively reducing patient anxiety and discomfort while enhancing surgical success rates.

 

Superior Visibility

Utilizing a unique algorithm tailored for hysteroscopy, our device delivers sharper images, truer colors, and uniform brightness, ensuring a clear view for accurate diagnostics and interventions.

 

Unparalleled Efficiency

Designed for efficiency, the SeleneView® disposable hysteroscope is ready for immediate use, providing rapid uterine distension in just 5 seconds. With a 140° wide field of view for swift exploration of fallopian tube openings and compatibility with 5Fr instruments, it allows for immediate diagnostics and treatments.

 

We are excited about the positive impact our single-use hysteroscope will have on gynecology, empowering healthcare professionals with state-of-the-art tools to elevate patient care standards and treatment outcomes.

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.