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.

IceCure Medical Ltd.（ICCM）已向FDA提交了一份监管审查请求，要求该机构拒绝该公司从头分类请求，以治疗早期低风险乳腺癌患者。IceCure于2022年10月向FDA提交了从头申请。

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.

2023年9月20日，IceCure宣布FDA否认其从头请求我们相信上诉程序允许我们与FDA合作确定适当的比较组，并且随后对数据的分析可能支持从头提交和上市许可的授予，“首席执行官Eyal Shamir说。

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