Edap bails on Ablatherm PMA, to seek de novo clearance from FDA

Edap says it's bailing out on the pre-market approval bid for its Ablatherm prostate cancer device and plans to seek de novo clearance from the FDA instead.

EDAP TMS SA, Food & Drug Administration (FDA)

News Well, De Novo Clearance, Men's Health, Pre-Market Approval (PMA), Regulatory/Compliance, Urology

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