Devices

FDA Clears Breast Thermography Device

FDA has cleared a Niramai Health Analytix 510(k) for its SMILE-100 System, a breast thermography device that is intended to help healthcare professionals review, measure and analyze thermally significant areas in the breast region. The device, which is designed to be used in the hospital, acute care settings, outpatient surgery settings, and healthcare practitioner facilities, is intended for use as adjunctive diagnostic imaging, the company says.

“The SMILE-100 System assists experts to visualize high thermal activity patterns clearly demarcated on thermal images as hotspots and can enable healthcare professionals to make better decisions in breast cancer screening and diagnosis,” the company says. “Another unique feature of SMILE-100 is use of their patented artificial intelligence-based algorithms to check the quality of input thermal images, which can greatly reduce the errors in thermal image capture and enable low skilled health workers to confidently perform the imaging.”

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