FDA to Convene Advisory Panel for Review of IceCure’s De Novo Marketing Clearance Request for ProSense®, Decision Expected Early 2025; Aligns with Commercial Readiness Plan

June 4, 2024

https://www.prnewswire.com/news-releases/fda-to-convene-advisory-panel-for-review-of-icecures-de-novo-marketing-clearance-request-for-prosense-decision-expected-early-2025-aligns-with-commercial-readiness-plan-302162960.html

CAESAREA, Israel, June 4, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration (“FDA”) will convene a Medical Device Advisory Committee for a panel meeting (the “Advisory Panel”) to obtain independent expert advice on scientific, technical, and policy matters related to ProSense® to help the FDA make a sound decision.

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