Gradient Denervation Technologies has joined the FDA’s Total Product Life Cycle Advisory Program (TAP), which provides early regulatory guidance to speed innovation.
The Paris-based startup is developing a catheter-based system that uses ultrasound to ablate nerves around the pulmonary artery—aiming to reduce pressure and resistance in pulmonary hypertension.
The move follows FDA breakthrough device designation and supports Gradient’s push toward pivotal trials and U.S. approval.
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