IceCure Medical Announces That A Large Number Of Public Comments Have Been Posted From Key Stakeholders Ahead Of The U.S. FDA Medical Device Advisory Committee Panel For Marketing Authorization Of ProSense Cryoablation In Early-Stage Low Risk Breast...
IceCure Medical Announces That A Large Number Of Public Comments Have Been Posted From Key Stakeholders Ahead Of The U.S. FDA Medical Device Advisory Committee Panel For Marketing Authorization Of ProSense Cryoablation In Early-Stage Low Risk Breast...
IceCure Medical Announces That A Large Number Of Public Comments Have Been Posted From Key Stakeholders Ahead Of The U.S. FDA Medical Device Advisory Committee Panel For Marketing Authorization Of ProSense Cryoablation In Early-Stage Low Risk Breast Cancer, Which Is Scheduled To Take Place On Thursday, November 7, 2024
IceCure Medical宣佈,在2024年11月7日星期四舉行的美國FDA醫療器械諮詢委員會專門討論ProSense冷消融技術獲得早期低風險乳腺癌營銷授權之前,大量關鍵利益相關方已經發表了公開評論。
- Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA website
- FDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense Cryoablation System in early-stage low risk breast cancer scheduled for November 7, 2024
- FDA網站上公開了包括醫生、護士、研究人員和乳腺癌患者在內的關鍵利益相關方的評論。
- FDA諮詢委員會將就IceCure ProSense冷消融系統在早期低風險乳腺癌De Novo營銷申請的獲益風險概況提供建議和投票,預定於2024年11月7日進行。
CAESAREA, Israel, Oct. 29, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:ICCM) ('IceCure', 'IceCure Medical' or the 'Company'), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that a large number of public comments have been posted from key stakeholders ahead of the U.S. Food and Drug Administration (the 'FDA') Medical Device Advisory Committee Panel (the 'Advisory Panel') for marketing authorization of ProSense cryoablation in early-stage low risk breast cancer, which is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel will include breast surgeons, interventional radiologists, industry representatives from the regulatory community, and other experts.
以色列,CAESAREA, 2024年10月29日 /美通社/--IceCure Medical Ltd.(納斯達克:ICCM)('IceCure','IceCure Medical'或'公司'),研發以冷凍爲基礎的微創冷凍消融技術,通過冷凍銷燬腫瘤作爲替代手術切除腫瘤的方式。今天宣佈,大量關鍵利益相關方已在美國食品藥品監督管理局('FDA')醫療器械諮詢委員會('諮詢委員會')授權ProSense冷凍消融技術在早期低風險乳腺癌治療中發表了公開評論。諮詢委員會旨在爲FDA獲取獨立的專家意見,涉及授予ProSense用於早期低風險浸潤性乳腺癌患者的冷凍消融和輔助內分泌治療的潛在市場授權。 諮詢委員會將包括乳腺外科醫生、介入放射科醫生、來自監管界的行業代表以及其他專家。
譯文內容由第三人軟體翻譯。