Devices

Fujifilm AI Colonoscopy Polyp Detector Cleared

FDA has cleared a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging. The device provides real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, supporting endoscopists in their ability to detect and remove pre-cancerous lesions, regardless of size, shape and color, according to the company. Comprising the company’s compatible expansion unit (the Fujifilm EX-1) and endoscopy support software (EW10-EC02), the device was developed using deep learning technology in Fujifilm’s Tokyo-based global AI technology center and validated in several studies using histologically confirmed polyps in clinical images obtained through Fujifilm’s endoscopy systems.

The company says the device’s technology is designed to support detection of lesions that may be easiest to miss, such as flat lesions, those at the corner of the endoscopic view, and multiple lesions present in a single frame. “When a suspicious polyp is detected by CAD EYE, the physician is automatically given both visual and auditory alerts: a ‘Detection Box’ appears, a ‘Visual Assist Circle’ illuminates in the area, and an alert is sounded, which can be adjusted per the user’s preferences,” it says. “The visual cues are overlaid on top of – but do not interfere with – clinical images in the physician’s existing workflow.”

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