Devices

Advisors Asked for ProSense Benefits, Risks

FDA is asking members of its General and Plastic Surgery Advisory Committee to comment on the risks and benefits of IceCure Medical’s ProSense cryoblation system intended to be used in patients with early-stage, low-risk breast cancer as an alternative to breast-conserving surgery (lumpectomy). A briefing paper distributed in advance of the 11/7 committee meeting says ProSense offers a minimally invasive method of ablating localized breast tumors … in early-stage, low-risk breast cancer patients. “The treatment can be performed under local anesthesia as an alternative to the standard of care lumpectomy,” it says.

Advisory committee members were asked to comment on these questions:

the strengths and limitations of standard-of-care imaging technology to accurately characterize tumor size and extent before surgery or cryoblation treatment in early-stage, low-risk breast cancer patients;
the strengths and limitations of the single-arm, nonrandomized study design using a literature-derived performance goal for the primary endpoint;
the strengths and limitations of each analysis population and subpopulation for determining the benefit versus risk of the ProSense system for the proposed indication for use;
the overall significance of the effectiveness results in the study compared to the systematic literature review and meta-estimate results;
how the safety results inform the benefit and risk of the ProSense system;
the quality of life benefits of surgery avoidance relative to the quality of life risks of breast cancer recurrence for the intended patient population; and
the overall benefit/risk profile of the device for the proposed indication for use in the treatment of early-stage, low-risk breast cancer in lieu of lumpectomy.

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