AMBU LAUNCHES HD CYSTOSCOPY SOLUTION IN THE U.S.
Following the FDA clearance for the Ambu® aScope™ 5 Cysto HD solution, Ambu introduces its HD cystoscope to urologists in the USA, expanding the urology offering and meeting advanced needs for cystoscopy procedures requiring superior image quality.
Today, Ambu announces FDA clearance of its newest cystoscopy solution, the Ambu® aScope™ 5 Cysto HD, in combination with the company’s two full-HD endoscopy systems, Ambu® aView™ 2 Advance and Ambu® aBox™ 2.
The clearance grants U.S. healthcare professionals access to Ambu’s expanded urology portfolio, which now features three single-use endoscopes – Ambu® aScope™ 4 Cysto, Ambu® aScope™ 5 Uretero and Ambu® aScope™ 5 Cysto HD – fully integrated with Ambu’s portfolio of endoscopy systems.
The Ambu® aScope™ 5 Cysto HD solution is specifically designed to support urologists during procedures requiring superior imaging, such as select bladder cancer screenings and bladder tumour removals. This is supported by the solution’s high-resolution camera chip and advanced image enhancement technology.
Ambu obtained European regulatory clearance (CE mark) of the solution in October 2023. Following the recent FDA clearance, Ambu plans to engage directly in a commercial launch in the USA, the company’s biggest market. The launch includes both the HD cystoscope and Ambu’s ureteroscope, which is designed to function as an all-purpose endoscope for urologists performing both diagnostic and therapeutic ureteroscopy procedures.
The combination of Ambu® aScope™ 4 Cysto, the Ambu® aScope™ 5 Cysto HD and Ambu® aScope™ 5 Uretero now provides urologists and their staff an extensive portfolio of advanced solutions that address a wide range of patient needs in urology. From development and manufacturing to distribution and sale, Ambu owns the entire product lifecycle for its full endoscopy portfolio.
The Ambu® aScope™ 4 Cysto will continue to serve a wide range of standard cystoscopy procedures across outpatient clinics and hospitals, while the Ambu® aScope™ 5 Cysto HD will target specific procedures requiring superior image quality. It will be priced at a premium, compared to the Ambu® aScope™ 4 Cysto.
Ambu CEO, Britt Meelby Jensen, is excited about the upcoming U.S. launch of Ambu’s expanded urology offering:
"Our expanded urology portfolio underscores our commitment to meeting the evolving needs of urologists and nurses, ensuring they have the best solutions at their disposal for unlocking workflow efficiency and enhancing patient outcomes. Our expanded urology portfolio targets a wide range of needs, and I am excited about the potential it holds for transforming patient care in the field."
BRITT MEELBY JENSEN
Chief Executive Officer, Ambu
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Contacts
Anders HjortHead of Investor Relations
Tel:+45 2892 8881anhj@ambu.comTine Bjørn SchmidtHead of Corporate Communications
Tel:+45 2264 0697tisc@ambu.comDocuments
About Ambu
Since 1937, Ambu has been rethinking solutions together with healthcare professionals, to save lives and improve patient care. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia and patient monitoring solutions. Headquartered near Copenhagen in Denmark, Ambu employs around 4,900 people in Europe, North America, Latin America and Asia Pacific. For more information, please visit Ambu.com.
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