Devices

Cosmo AI Colonoscopy Aid Authorized

FDA has granted Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.

The authorization was based on data from a multicenter, prospective, randomized, controlled study in Italy with 700 subjects aged 40-80 years who were undergoing a colonoscopy for colorectal cancer screening and surveillance, according to a FDA news release. “The primary endpoint of the study compared how often colonoscopy plus GI Genius identified a patient with at least one lab-confirmed adenoma (precancerous tumor) or carcinoma (cancerous tumor) to how often standard colonoscopy made the same identifications,” it says. “In the study, colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1% of patients compared to identifying them in 42.0% of patients with standard colonoscopy, an observed difference of 13%.”

FDA says the device is not intended to characterize or classify a lesion, nor to replace lab sampling as a means of diagnosis. It only identifies regions of the colon within the endoscope's field of view where a colorectal polyp might be located, allowing for a more extended examination in real time during colonoscopy, 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