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Diagnostics World | Many in vitro diagnostic (IVD) and over-the-counter test makers became interested in wellness claims after the FDA’s dispute with Whoop. They hoped to avoid standard medical device requirements. According to Dan Simpson, director of regulatory affairs at DCN Dx, that path is narrower than many assume.
Nov 10, 2026
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Diagnostics World News | Development of next-generation drugs for treating systemic inflammation and cognitive impairment is ready to begin, backed by a study linking abnormalities in the cerebellum and frontal lobe regions of the brain in pulmonary hypertension patients to the same processes driving the disease in their lungs and heart.
Nov 5, 2026
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Diagnostics World News | An analysis of more than 900,000 genomes sets a baseline for what a typical human genome contains, with implications for screening, VUS reporting, and polygenic scores.
Nov 3, 2026
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Diagnostics World | Zenflow closes $52M Series D to launch its BPH implant; Arboretum launches with $30M for clinical genetic testing in common diseases; and more.
Oct 28, 2026
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Diagnostics World News | Mursla Bio publishes peer-reviewed validation of its liver-focused extracellular vesicle liquid biopsy platform; new products from GE HealthCare and Geneoscopy; and more.
Oct 27, 2026