BETA
Clinical-stage microbubble-assisted ultrasound technology for urinary stone treatment.
Avvio Medical, formerly Applaud Medical, develops microbubble-assisted acoustic technology for urinary stone disease. Its Microbubble SonoLithotripsy platform combines a console, treatment head, ureteral catheter and proprietary microbubbles, aiming to fragment stones with low-intensity ultrasound.
The company’s San Francisco-based leadership includes CEO Paul Molloy. Its current site explicitly states that no Avvio devices are offered for sale or distribution and that market clearance has not been obtained in the U.S. or another jurisdiction. Breakthrough Device designation and reimbursement-code announcements do not change that investigational status.
The development program includes a prospective multicenter ELS study and earlier Acoustic Enhancer research used with laser lithotripsy. Those studies evaluate related but different interventions. Company website language about older AEROLITH analysis is not fully synchronized with its later publication announcement; the profile treats the two sources as different dated observations.
Investigational device; not available for routine commercial sale. [6][5][2][3][4][8]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [10][11]
Latest recorded source review: 2026-10-20.
No routinely marketed devices established in the reviewed scope.
NCT06942949: registry status recruiting in the 2026-06-16 update; 101 participants (estimated). Study completion is estimated for 2026-09; this is not an FDA decision or commercial launch date. [14]
Low-intensity ultrasound platform, catheter and acoustic-enhancer microbubbles intended for ureteral stone fragmentation. [5][3][1]
Investigational / in developmentInvestigational only; not commercially available.
Company reported FDA Breakthrough designation for ELS. Designation is not clearance or approval. [2]
Company announced treatment of initial patients in its new ELS clinical program; investigational activity, not commercial adoption. [7]
Accessed 10/20/2026