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first_img News | Artificial Intelligence | August 13, 2019 Artificial Intelligence Could Yield More Accurate Breast Cancer Diagnoses University of California Los Angeles (UCLA) researchers have developed an artificial intelligence (AI) system that… read more November 4, 2010 – The U.S. Food and Drug Administration (FDA) is easing the path to market for mammography systems that produce computerized X-ray images of the entire breast. Those devices will now be included in class II.These systems, known as full field digital (FFD) mammography systems, are an alternative to mammography systems that produce X-ray film.When first approved by the FDA in 2000, digital mammography systems were categorized as a high-risk, or class III, device. Since then, they have been well validated by studies and the benefits and risks have been well described to physicians. Class II includes medium-risk devices.“Our decision to reclassify these devices is consistent with feedback we’ve received from public discussions with appropriate medical and scientific experts as well as our stronger understanding of how these systems work,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.Companies must typically submit a pre-market approval application for a class III device, which requires proof of safety and effectiveness. Many class III devices involve new technology that has not been widely used.Class I and class II devices pose lower risk. Class II devices require submission of a pre-market notification, or 510(k), to establish that it is substantially equivalent to a device already on the market.For more information: www.fda.gov FacebookTwitterLinkedInPrint分享 News | November 04, 2010 FDA Reclassifies Certain Digital Mammography Devices News | Brachytherapy Systems | August 14, 2019 Efficacy of Isoray’s Cesium Blu Showcased in Recent Studies August 14, 2019 — Isoray announced a trio of studies recently reported at scientific meetings and published in medica read more News | Neuro Imaging | August 16, 2019 ADHD Medication May Affect Brain Development in Children A drug used to treat attention-deficit/hyperactivity disorder (ADHD) appears to affect development of the brain’s… read more News | Pediatric Imaging | August 14, 2019 Ultrasound Guidance Improves First-attempt Success in IV Access in Children August 14, 2019 – Children’s veins read more News | Radiation Therapy | August 15, 2019 First Patient Enrolled in World’s Largest Brain Cancer Clinical Trial Henry Ford Cancer Institute is first-in-the-world to enroll a glioblastoma patient in the GBM AGILE Trial (Adaptive… read more Related Content Image courtesy of Imago Systems News | Colonoscopy Systems | August 06, 2019 Rise in Early Onset Colorectal Cancer Not Aligned With Screening Trends A new study finds that trends in colonoscopy rates did not fully align with the increase in colorectal cancer (CRC) in… read more News | CT Angiography (CTA) | August 06, 2019 Artificial Intelligence Improves Heart Attack Risk Assessment When used with a common heart scan, machine learning, a type of artificial intelligence (AI), does better than… read more News | Cardiovascular Ultrasound | August 07, 2019 Contrast Use in First Transthoracic Echocardiogram for Heart Failure Reduces Repeat Testing Heart failure is the fourth most common cause for all admission to U.S. hospitals, and it is the most common reason for… read more News | Mammography | August 14, 2019 Imago Systems Announces Collaboration With Mayo Clinic for Breast Imaging Image visualization company Imago Systems announced it has signed a know-how license with Mayo Clinic. The multi-year… read more Images of regions of interest (colored lines) in the white matter skeleton representation. Data from left and right anterior thalamic radiation (ATR) were averaged. Image courtesy of C. Bouziane et al. News | Breast Imaging | August 02, 2019 Volpara to Distribute Screenpoint Medical’s Transpara AI Solution Volpara Solutions and ScreenPoint Medical BV signed an agreement under which Volpara will sell ScreenPoint’s Transpara… read morelast_img

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