Update
$Icecure Medical(ICCM.US$ IceCure Medical Seeks FDA Clearance for Cryoablation Technology
MT Newswires· 1 min ago
IceCure Medical (ICCM) said Tuesday it filed an application with the US Food and Drug Administration for clearance of XSense, a single probe cryoablation technology.
The 501(k) submission for XSense covers all indications for which ProSense, an early iteration of the technology, is already approved, according to the company.
IceCure said this application is separate from its de novo request for breast cancer.
MT Newswires· 1 min ago
IceCure Medical (ICCM) said Tuesday it filed an application with the US Food and Drug Administration for clearance of XSense, a single probe cryoablation technology.
The 501(k) submission for XSense covers all indications for which ProSense, an early iteration of the technology, is already approved, according to the company.
IceCure said this application is separate from its de novo request for breast cancer.
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