IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes [Yahoo! Finance]
IceCure Medical Ltd. - Ordinary Shares (ICCM)
Company Research
Source: Yahoo! Finance
CAESAREA, Israel April 2, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology. This new application for IceCure's next-generation single probe XSense™ with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication.
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News
- IceCure Medical (ICCM) Submits Final Cryoablation Data to FDA [Yahoo! Finance]Yahoo! Finance
- IceCure Medical Ltd (NASDAQ: ICCM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $3.00 price target on the stock.MarketBeat
- IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer [Yahoo! FinaYahoo! Fina
- IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast CancerPR Newswire
- IceCure Medical Ltd (NASDAQ:ICCM) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
ICCM
Earnings
- 5/22/23 - Beat
ICCM
Sec Filings
- 4/15/24 - Form 6-K
- 4/15/24 - Form 6-K
- 4/3/24 - Form 6-K
- ICCM's page on the SEC website