Posted by Michael Wonder on 01 Feb 2022
Applaud Medical receives FDA breakthrough device designation for the company’s acoustic enhancer for use in conjunction with ureteroscopy with laser lithotripsy for the fragmentation of calcium based kidney stones
31 January 2022 - Applaud Medical today announced that its acoustic enhancer technology has received breakthrough device designation from the U.S. FDA.
The acoustic enhancer technology is designed to be used in conjunction with ureteroscopy with laser lithotripsy for the fragmentation of calcium based urinary stones of at least 6mm and not more than 20mm in diameter that are obstructing or deemed to present a significant risk of future obstruction by a urologist or other qualified physician, which can place patients at risk of future sepsis, chronic kidney disease, or end stage renal disease.
