IceCure Files Appeal On FDA Denial Of De Novo Classification For ProSense

(RTTNews) - IceCure Medical Ltd. (ICCM) has filed a request for supervisory review with the FDA regarding the agency's denial of the company's De Novo Classification Request for treating patients with early-stage, low risk breast cancer. IceCure filed the De Novo request for ProSense with the FDA in October 2022. On September 20, 2023, IceCure announced that the FDA denied its De Novo request.

"We believe the appeal process allows us to work with the FDA to identify an appropriate comparator group and that a subsequent analysis of the data may support the granting of the De Novo submission and marketing authorization," said Eyal Shamir, CEO.

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