Avvio Medical Inc, a clinical-stage medical device company developing advanced kidney stone treatment technologies, has announced that the USA Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to its Enhanced Lithotripsy System (ELS). The designation recognises the system’s potential to improve patient outcomes, minimise complications, and expand access to minimally invasive, anaesthesia-free kidney stone care for millions affected by ureteral stones each year.

The FDA’s Breakthrough Device Designation programme is designed to accelerate patient access to transformative technologies that represent a meaningful improvement in safety or effectiveness. This designation provides Avvio Medical with priority interaction and a streamlined review process, allowing closer collaboration with FDA reviewers as the company advances its clinical programme and prepares for a De Novo submission in early 2026.

“The FDA’s recognition of Avvio ELS as a breakthrough device marks a major milestone for our company and for the patients who will benefit from more accessible, less invasive treatments,” said Paul Molloy, Chief Executive Officer of Avvio Medical. “This designation validates our clinical evidence and establishes a clear, collaborative path with the FDA as we move toward De Novo submission and eventual market launch.”

The FDA also considers health equity and access in its breakthrough designations, supporting technologies that can reduce disparities in care. The Avvio ELS enables kidney stone treatments outside traditional operating rooms — in outpatient and ambulatory surgery centre (ASC) settings, and eventually in doctors’ offices — eliminating the routine need for general anaesthesia or stenting. This approach supports value-based care, lowers procedural costs, shortens recovery times, and improves access for Medicare-aged patients, who represent a large proportion of those affected by stone disease.

Avvio Medical is currently conducting its pivotal Enhanced Lithotripsy System clinical trial in the USA under an active Investigational Device Exemption (IDE), with plans for a commercial launch following FDA clearance in 2026.

The Enhanced Lithotripsy System employs microbubble-enhanced acoustic cavitation lithotripsy, enabling kidney stone treatments to shift from the operating room to more accessible outpatient environments. This single, minimally invasive therapy is suitable for Ambulatory Surgery Centres and cystoscopy suites, requiring no general anaesthesia, fluoroscopy, or high-cost capital equipment. The system delivers significant clinical and economic advantages for both patients and healthcare providers.