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 ...
Aqua Medical has received investigational device exemption (IDE) from the FDA for its ablation device aimed at treating ...
The medical device industry demands constant innovation, with new products required to be safe, reliable, and efficient.
Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.
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