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Diagnostics World News | At the 2019 Next Generation Dx Summit in August, a staff fellow with the FDA shared the agency's approach to evaluating medical devices enabled by "adaptive" artificial intelligence and machine learning—meaning they continuously learn as they're exposed to more data.
Oct 16, 2019
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Diagnostics World News | The FDA has been unusually busy over the past two years on programs and projects advancing regulatory science around in vitro diagnostics, including digital pathology.
Oct 15, 2019
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STAT | Men account for about 1% or less of all breast cancer diagnoses in the U.S., yet male breast cancer patients have a 19% higher mortality rate than their diagnosed female counterparts, according to a recent study in JAMA Oncology.
Oct 11, 2019
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Diagnostics World News | Due to opposing market forces and technology innovation in both the central lab and point-of-care diagnostics settings, overall diagnostic testing is trending more slowly toward decentralization than some might expect, according to Berkeley, California-based diagnostics consultant Lucy Hattingh.
Oct 10, 2019
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Diagnostics World News Brief | Illumina and QIAGEN announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.
Oct 9, 2019
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Diagnostics World News | Ativa Medical created buzz at last month's Next Generation Dx Summit in Washington, D.C. with a presentation about its workhorse point-of-care (POC) device being developed expressly for primary care.
Oct 8, 2019
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Diagnostics World News Brief | Researchers at The University of Texas at Austin and Baylor College of Medicine have developed a new preoperative test for thyroid cancer that is faster and about two-thirds more accurate than the diagnostic tests doctors use today.
Oct 7, 2019
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Diagnostics World News | Congenica today announced the integration of new reference data sources into its clinical decision support platform: data from DECIPHER and a partnership with Genomenon and its Mastermind solution.
Oct 2, 2019
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Diagnostics World News | September featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including FemtoDx, PGDx, Illumina, and more.
Sep 30, 2019
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Diagnostics World News Contributed Commentary | In less than 12 months, the world’s second-largest market for medical technologies will be overhauled with the implementation of the European Union’s new Medical Device Regulation, and shortly thereafter, the In Vitro Diagnostic Regulation. Medical device manufacturers will face new challenges as these regulations are introduced, and these challenges will ultimately affect the patients that need these devices.
Sep 24, 2019
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Diagnostics World News | Widespread adoption of electronic health records (EHRs) has led to some disturbing communication snafus in the pathology results reporting process that some provider organizations are actively working to mitigate.
Sep 17, 2019
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Diagnostics World News | ESN Cleer, a Melbourne-based startup, is looking to predict heart failure and other cardiac diseases using a patient's saliva.
Sep 16, 2019
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Diagnostics World News Contributed Commentary | Despite remarkable potential, microbiome research—and the diagnostics and therapeutics that will one day be developed based on these findings—is severely limited by century-old microbiology tools.
Sep 13, 2019