FDA grants 510(k) clearance to Ambu’s single-use ureteroscope

The FDA has granted 510(k) clearance to Ambu’s ureteroscopy solution, consisting of the single-use digital flexible ureteroscope, aScope 5 Uretero, and the full-HD endoscopy system, aBox 2, the company announced in a news release.¹

The ureteroscopy solution was granted regulatory clearance in Europe in November 2023.

In November 2023, the ureteroscopy solution was granted a CE mark for regulatory clearance in Europe.² In the US, the company plans to make the solution available in select health care centers first before initiating a full-scale global launch by the end of this financial year.

"This clearance in the US of our new ureteroscopy solution not only demonstrates a market expansion for Ambu; it is a testament to the progressive shift towards single-use solutions within the field of urology. I am confident that our continuous technology advancements will rapidly pave the way for better and more efficient patient care in the future – improving outcomes for patients, physicians, and health systems alike,” said Britt Meelby Jensen, chief executive officer for Ambu, in the news release.¹

According to the company, their ureteroscope is the first in the world to be made with bioplastics, which are “materials derived from a mix of fossil-based and second-generation feedstock, e.g., recycled food waste.” The bioplastic materials used by Ambu are called bio-attributed plastics (Bio-ABS), which, according to the company, reduce the carbon footprint of endoscope handle production with regular ABS plastics by 70%.2 Ambu plans to integrate bioplastic material into their entire endoscopic portfolio by the end of 2024.

The company also noted that the aScope 5 Uretero was developed in close collaboration with leading urology experts to gain insight on multifaceted use, versatility, and reliability.

"As an endourologist, I am excited to work with Ambu’s growing single-use endoscopy portfolio. The quality and performance of Ambu’s current aScope 4 Cysto has been an asset to my practice and the system I work in. I am confident that aScope 5 Uretero will provide similar value. The aScope 5 Uretero incorporates a variety of interesting features, including improved optics, small size, and it being the first ureteroscope manufactured with bioplastics. I look forward to testing the clinical performance of aScope 5 Uretero in a variety of endourologic procedures,” said Michael A. Palese, MD, in the news release.¹ Palese is the chair of the department of urology at Mount Sinai Health System in New York, New York.

In addition to the aScope 5 Uretero, the company also offers 2 other single-use endoscopes: aScope 4 Cysto and aScope 5 Cysto HD, which can be used with the aViewTM 2 Advance and aBox 2 systems.²

References

1. Ambu obtains FDA clearance for new ureteroscopy endoscopy solution. News release. Ambu. June 26, 2024. Accessed July 2, 2024. https://www.ambu.com/Files/Files/Ambu/Investor/News/English/2024/Ambu-obtains-FDA-clearance-for-new-ureteroscopy-endoscopy-solution.pdf

2. Ambu obtains CE mark of ureteroscopy solution. News release. Ambu. November 29, 2023. Accessed July 2, 2024. https://www.ambu.com/Files/Files/Ambu/Investor/News/English/2023/Ambu-obtains-CE-mark-of-ureteroscopy-solution.pdf