Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems
Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems are connected with a VCR, the high fluoroscopy mode may not fully comply with the fluoroscopic recording provisions of FDA regulations. Philips is investigating the letter's claims and plans to issue a corrective action. In the meantime, Integris 3000 users should make sure that the VCR is recording prior to using the high fluoroscopy mode, according to the company. Philips said that the letter does not affect its newer Integris 5000 products.
Can CT-Based AI Provide Automated Detection of Colorectal Cancer?
February 14th 2025For the assessment of contrast-enhanced abdominopelvic CT exams, an artificial intelligence model demonstrated equivalent or better sensitivity than radiologist readers, and greater than 90 percent specificity for the diagnosis of colorectal cancer.
Emerging MRI Scoring System May Help Predict Recurrent and Metastatic Hepatocellular Carcinoma
February 12th 2025Preoperative use of the scoring system for gadoxetic acid-enhanced MRI demonstrated an average AUC of 85 percent and average specificity of 89 percent in external validation cohorts for pathologic features of hepatocellular carcinoma.