Devices

Guided Therapeutics Study Protocol for Cervical Scan

Guided Therapeutics has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan. According to the protocol, the company says LuViva will be studied to assess its ability to help detect a significant number of the up to 40% to 50% of cervical cancer cases missed at the point of biopsy because of limitations in current imaging technology. “New national guidelines for cervical cancer management published in April of 2020 stress a risk based approach, a feature already included in LuViva’s AI based risk profile algorithms,” it says. “Because the available technology of visually examining the cervix under magnification often cannot detect the correct area to biopsy, or at times fails to detect the disease at all, there is a strong need for a more sensitive test like LuViva to identify more women with disease so treatment can begin sooner.”

The device is based on the science of biophotonics to scan cervical tissue with fluorescence and reflectance spectroscopy to detect chemical and structural changes at the cellular level. “These changes from normal conditions can indicate high-grade or moderate dysplasia as classified by pathology as cervical intraepithelial neoplasia 2 or above,” the company says. “Unlike the Pap smear, liquid-based cytology or biopsy LuViva is designed to provide a result immediately after the scan with no waiting for laboratory reports.” The scanning technology can see about 3mm below the surface of the tissue to detect disease before it may be visible to colposcopy, it says.

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