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FDA device chief resigns
The director of the FDA Center for Devices and Radiological Health, Daniel Schultz, stepped down earlier this week amid allegations that he inappropriately exerted pressure on reviewers to approve devices for the U.S. market.
FDA device chief resigns
The director of the FDA Center for Devices and Radiological Health, Daniel Schultz, stepped down earlier this week amid allegations that he inappropriately exerted pressure on reviewers to approve devices for the U.S. market. FDA Associate Commissioner for Policy and Planning Jeff Shuren will step in as interim CDRH director.Schultz, who became CDRH director in 2004, came under fire after nine scientists wrote to the Obama administration transition team complaining they were pushed to approve faulty medical devices. In a letter to agency staffers, Daniel Schultz said he and FDA Commissioner Margaret Hamburg agreed his resignation "would be in the best interest of the center and the agency," according to the Associated Press. Hamburg was appointed by President Obama to restore the FDA’s credibility, which has suffered recently with drug recalls, such as the pain reliever Vioxx, and illnesses due to food poisoning.
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.
