Devices

Perspectum’s Liver Cancer Support Tool Cleared

FDA has cleared a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer. The device a quantitative multiparametric MRI to provide a liver health assessment based on artificial intelligence (AI)-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat, according to the company. “Using AI to delineate the liver and calculate regional volumes saves over 20 minutes of pre-operative radiology time per case,” it says.

The clearance was based on data from a UK-based study of 143 surgical candidates which showed that by combining estimated future liver remnant with an assessment of underlying fibro-inflammation, Hepatica could effectively identify patients at risk of poor outcomes from surgery and a longer stay in hospital, Perspectum says. This information, it adds, helps tumor boards and multidisciplinary teams make more informed pre-operative decisions to improve post-operative outcomes for patients.

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

Read more

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