August 11, 2026 — The global High Risk IMDRF Category III & IV Software as a Medical Device market is projected to grow from USD 4.8 billion in 2026 to USD 16.9 billion by 2036, at a 13.4% CAGR, according to Fact.MR. Fact.MR also reports that the market reached USD 4.2 billion in 2025.
Demand is rising as healthcare providers use more software for diagnosis,...
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