Devices

Panel Backs Lumisight Breast Surgical Imaging

FDA’s Medical Imaging Drugs Advisory Committee has voted 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agent for use in patients with breast cancer. The combination product is intended for use with the Lumicell Direct Visualization System as an intracavity, fluorescence-guided surgical imaging tool for detecting residual cancer in real-time during a lumpectomy surgery (breast conserving surgery), according to the company.

Currently, the company says the standard of care for a lumpectomy involves breast surgeons and pathologists examining excised breast tissue post-surgery to determine whether any residual cancer remains behind in the breast cavity. “As a result, 9-36% of lumpectomies have positive margins only identified days after surgery, necessitating the patient to undergo a second surgery or reoperation to obtain clear margins or removal of all cancerous tissue,” it says.

The panel’s positive vote was based on data presented by Lumicell, including efficacy data in over 350 patients in the pivotal study and safety findings from more than 700 patients across six clinical studies, according to the company. Data from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial were published in NEJM Evidence.

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