The IDE approval marks a pivotal milestone for Aqua Medical, allowing the company to begin enrolling patients in the U.S. RESTORE-1 pilot trial and study PIMA's potential to deliver durable metabolic ...
Patients with implanted medical devices like orthopedic joint replacements, pacemakers, and artificial heart valves run a small but significant risk that these devices get infected with bacterial ...
The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S.-based pivotal clinical trial. For more information on ...
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