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A review of the cost-effectiveness analysis (CEA) literature has found that only around 25% of the major pre-market approved (PMA) device categories have published cost-effectiveness evidence available through PubMed, however, the researchers note that of those with data available, the devices generally offer good value for money according to commonly used cost-effectiveness thresholds. There was at least one cost-utility or comparative-effectiveness study for 88 (16%) of non-cosmetic medical devices approved by the US FDA in the study time frame, and >=1 device across 53 (26.2%) generic categories. The study, published in I Applied Health Economics and Health Policy i , searched PubMed for research reporting the incremental costs and incremental quality-adjusted life-year (QALY) gains versus previously-available treatment of PMA devices approved by the US Food and Drug Administration (FDA) (1999-2015). [Extracted from the article]