Devices

Hologic’s Cervical Cancer Diagnostic Cleared

FDA has cleared a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology system that the company says combines deep-learning-based artificial intelligence with volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.

Traditional screenings for cervical cancer include a Pap test, where a sample is collected at an OB-GYN office and sent to a lab for examination under a microscope, according to the company. “With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review,” it says.

Hologic also notes that the device offers the opportunity for greater collaboration across lab and other healthcare settings. “The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts,” 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