Milestone
Nov 2024
FDA pre-sub meeting
JS
Jun 5, 2025
Very positive pre-sub meeting with the device section of the FDA. They had no objections to our proposed predicate device, clinical trial plan, or regulatory path of Class I, 510(k).
Very positive pre-sub meeting with the device section of the FDA. They had no objections to our proposed predicate device, clinical trial plan, or regulatory path of Class I, 510(k).