IceCure gets favorable FDA AdCom vote for ProSense System [Seeking Alpha]
IceCure Medical Ltd. - Ordinary Shares (ICCM)
Company Research
Source: Seeking Alpha
for its ProSense System for the destruction of early-stage breast cancer tumors using cryoablation technology. The committee voted 9 to 5 that the benefits of the system outweighed the risks. Three of the five that voted against also said that they would be in favor if the FDA applied adequate controls, according to a statement. The Israeli company is seeking to have the system approved for the treatment of early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. IceCure said it expects to make a decision on whether to authorize the product in Q1 2025. More on IceCure Medical IceCure Medical Ltd (ICCM) Q2 2024 Earnings Call Transcript FDA AdComm to discuss IceCure's ProSense on Nov. 7 Seeking Alpha's Quant Rating on IceCure Medical Historical earnings data for IceCure Medical Financial information for IceCure Medical Recommended For You Comments Recommended For You More Trending News
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News
- Breast Cancer Patients who Underwent IceCure's ProSense® Cryoablation in Japan Reported Significantly Higher Satisfaction than Patients who Underwent Standard of Care Surgery [Yahoo! Finance]Yahoo! Finance
- Breast Cancer Patients who Underwent IceCure's ProSense® Cryoablation in Japan Reported Significantly Higher Satisfaction than Patients who Underwent Standard of Care SurgeryPR Newswire
- IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel [Yahoo! Finance]Yahoo! Finance
- IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in IsraelPR Newswire
- IceCure's ProSense® in the Spotlight at Society of Interventional Oncology (SIO) Annual Meeting: Award Winning Abstract and Hands-On Training for Breast Cryoablation as Medical Community Anticipates FDA's Market Authorization DecisionPR Newswire
ICCM
Earnings
- 5/28/24 - In-Line
ICCM
Sec Filings
- 3/10/25 - Form 6-K
- 2/24/25 - Form 6-K
- 2/4/25 - Form 6-K
- ICCM's page on the SEC website