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MedTech & AI-SaMD in 2025: Growth, Regulation, and Confidence in Innovation
HealthTech Horizons By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors As we close out 2025, a year of rapid transformation, investor recalibration, and regulatory evolution, it’s worth stepping back and assessing where MedTech, and in particular AI-enabled Software as a Medical Device (AI-SaMD), truly stands. 1) Funding: Healthy Growth — But Uneven On the funding front, the narrative for MedTech in 2025 is nuanced rather than dramatic: · Total
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Jan 254 min read
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