Devices

FDA Authorizes Cryoablation for Low-Risk Breast Cancer

FDA has granted IceCure Medical’s de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-risk breast cancer in women aged 70 years and older who are also receiving adjuvant endocrine therapy. The company says ProSense offers a minimally invasive, outpatient alternative to lumpectomy, using extreme cold to destroy tumors without removing breast tissue. The system allows physicians to insert a thin, hollow cryoprobe into the tumor under ultrasound guidance, where liquid nitrogen cools the probe to –170°C, creating an ice ball that freezes and eliminates the targeted tissue.

FDA’s decision was supported by results from the ICE3 clinical trial, which followed 194 women aged 60 and older with low-risk, early-stage disease. Only 3.1% of patients experienced local recurrence within five years after undergoing cryoablation and endocrine therapy, IceCure says. Most side effects — such as swelling, bruising, or mild pain—were minor and resolved without lasting impact.

The marketing authorization covers patients aged 70 and above with biologically low-risk tumors no larger than 1.5 cm, and no lymph node involvement. It also includes patients deemed unsuitable for surgical treatment.

As part of the approval, IceCure will conduct a post-market surveillance study involving about 400 patients across 30 sites to further evaluate the procedure’s outcomes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome