IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
IceCure Medical Ltd. - Ordinary Shares (ICCM)
Company Research
Source: PR Newswire
IceCure working in close collaboration with FDA towards De Novo decisionCAESAREA, Israel, March 20, 2025 /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 it is in continued discussions with the U.S. Food and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense® in early-stage low risk breast cancer with endocrine therapy. The Company now expects the FDA's marketing authorization decision to be reached after the first quarter of 2025."Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense® for the treatment of early-stage, low-risk breast cancer with endocrine therapy" stated IceCure's Chief Executive Officer, E
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News
- IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast CancerPR Newswire
- IceCure's ProSense® Cryoablation Featured in 4 Independent Breast Cancer Studies Presented at Radiological Society of America 2025 Annual Meeting [Yahoo! Finance]Yahoo! Finance
- IceCure's ProSense® Cryoablation Featured in 4 Independent Breast Cancer Studies Presented at Radiological Society of America 2025 Annual MeetingPR Newswire
- IceCure Receives Notice of Patent Allowance in China for a Novel Cryogen Flow Control to Optimize Patient Cryoablation Outcomes [Yahoo! Finance]Yahoo! Finance
- IceCure Receives Notice of Patent Allowance in China for a Novel Cryogen Flow Control to Optimize Patient Cryoablation OutcomesPR Newswire
ICCM
Earnings
- 8/13/25 - Miss
ICCM
Sec Filings
- 12/17/25 - Form 6-K
- 12/10/25 - Form 6-K
- 12/5/25 - Form 6-K
- ICCM's page on the SEC website