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The team at CDRH who was in charge of reviewing Small Business Determination requests was put on administrative leave in April, leading device companies to face delays and ambiguity in qualifying for reduced user fees for premarket submissions.
The first comprehensive, data-based analysis of US spending on healthcare by condition, an ongoing project of the Institute for Health Metrics and Evaluation at the University of Washington, aims to provide a more accurate assessment of US spending per disease, with potential to inform policy, industry, insurers, and other stakeholders. It concludes, to the surprise of some, we spend the most on type 2 diabetes, followed by musculoskeletal disorders and oral dental care.
Reimbursement strategies are key to succeeding in the growing, underserved market for women’s health technologies. Excerpted from our recent feature, The Business Case for Investing in Women’s Health.