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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.
AI Mammography Platform Shows Promising Results for Detecting Subclinical Breast Cancer
October 3rd 2024Mean artificial intelligence (AI) scoring for breasts developing cancer was double that of contralateral breasts at initial biennial screening and was 16 times higher at the third biennial screening, according to a study involving over 116,000 women with no prior history of breast cancer.
FDA Clears Software for Enhancing CCTA Assessment of Atherosclerosis
October 1st 2024Through analysis of coronary computed tomography angiography (CCTA) images, the PlaqueIQ software provides quantification and classification of atherosclerosis, a common cause of myocardial infarction (MI) and ischemic stroke.
