Devices

Melanoma Imaging Device Get Breakthrough Status

FDA has granted Orlucent a breakthrough device designation for the company’s Orlucent Skin Fluorescence Imaging System, a handheld point-of-care molecular-based device designed to identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults. “The Orlucent system is designed to be used by physicians, in conjunction with traditional clinical visual skin examination as well as information on the patient's skin type and medical history, to help physicians determine a clinical course of action and identify melanoma at its very earliest stages,” the company says.

To use the device for assessing an atypical lesion, a healthcare professional can apply the reagent and then use the imager to capture both white light and fluorescent images, the company says. Its image analysis software is then used to analyze and display the images as well as to provide a probability score for the presence of “tissue remodeling,” it says. “A physician can use the Orlucent system's score along with their clinical assessment in determining if they should remove the mole and send it for biopsy or continue to observe the mole with the potential to retest it with the Orlucent system in the future.”

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