Applaud Medical Receives FDA Breakthrough Device Designation for the Company’s Acoustic Enhancer for Use in Conjunction With Ureteroscopy With Laser Lithotripsy (URS-LL) for the Fragmentation of Calcium-Based Kidney Stones
Retrieved on:
Monday, January 31, 2022
Research, Medical Devices, FDA, Clinical Trials, Other Health, Health, General Health, Other Science, Science, Entrepreneurship, Erosion, Risk, Kidney, Acoustic enhancement, Patient, Laser lithotripsy, Food, Dyslipidemia, Medicine, Ureteroscopy, Columbia University Vagelos College of Physicians and Surgeons, Obstruction, Technology, Chronic kidney disease, Diabetes, Prevalence, Company, Incidence, Applause, Hypertension, Columbia University Irving Medical Center, Doctor of Philosophy, Sepsis, Obesity, Physician, Columbia University College of Dental Medicine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Division, FDA, Urologic disease, Medical imaging, Pharmaceutical industry, Urology, Surgeon
Applaud Medical, Inc. (Applaud), an emerging leader in the treatment of kidney stones, today announced that its Acoustic Enhancer technology has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
Key Points:
- Applaud Medical, Inc. (Applaud), an emerging leader in the treatment of kidney stones, today announced that its Acoustic Enhancer technology has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
- The Acoustic Enhancer microparticles generate additional stone-fragmenting shockwaves when used during a laser lithotripsy procedure.
- The Company is developing the Applaud Acoustic Enhancer, an innovative technology designed to enhance URS-LL in the fragmentation of kidney stones.
- The Company is also actively conducting a prospective, multicenter, randomized, double-blind study ( NCT04563039 ) for the Acoustic Enhancer when used in conjunction with URS-LL.