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Philips gets FDA warning letter
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.
MRI-Based AI Radiomics Model Offers 'Robust' Prediction of Perineural Invasion in Prostate Cancer
July 26th 2024A model that combines MRI-based deep learning radiomics and clinical factors demonstrated an 84.8 percent ROC AUC and a 92.6 percent precision-recall AUC for predicting perineural invasion in prostate cancer cases.
Breast MRI Study Examines Common Factors with False Negatives and False Positives
July 24th 2024The absence of ipsilateral breast hypervascularity is three times more likely to be associated with false-negative findings on breast MRI and non-mass enhancement lesions have a 4.5-fold likelihood of being linked to false-positive results, according to new research.
Can Polyenergetic Reconstruction Help Resolve Streak Artifacts in Photon Counting CT?
July 22nd 2024New research looking at photon-counting computed tomography (PCCT) demonstrated significantly reduced variation and tracheal air density attenuation with polyenergetic reconstruction in contrast to monoenergetic reconstruction on chest CT.
