Prosense® Kryoablation FDA Approved for Breast Cancer Treatment in Women 70+

by Grace Chen
written by Grace Chen

IceCure Medical’s Prosense® Receives FDA Market Approval for Early-Stage Breast Cancer

IceCure medical Ltd. announced today that the US Food and Drug Governance (FDA) has granted market approval for Prosense®, a minimally invasive cryoblation therapy. This approval is for the local treatment of early-stage, biologically low-risk breast cancer in women aged 70 and over – a US patient population estimated at 46,000 annually.

Key details of the approval:

  • First & Only: Prosense® is the first and only medical device FDA-approved for the local treatment of breast cancer.
  • Patient Criteria: Approval applies to patients with biologically low-risk tumors (maximum 1.5 cm) who are also receiving adjuvant endocrine therapy.
  • Biologically Low Risk Defined: Specifically, this includes unifocal tumors with a maximum size of 1.5 cm, that are ER+, PR+, Her2-, and Ki-67 positive.

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Dr Grace Chen – Health Editor

Board-certified physician and medical writer. Translates research into practical health advice and public-health coverage.

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