HomeHealthcareDiagnosticsSoftware as a Medical Device (SaMD)

Software as a Medical Device (SaMD)

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The Emerging Go-to-Market Strategy for AI/ML Healthcare Innovation

Whether driven by regulatory, reimbursement, policy, or investment tailwinds, 2026 is poised to be a pivotal year for healthcare innovation leveraging artificial intelligence and machine learning (AI/ML). This whitepaper examines why, despite this increasing regulatory flexibility for certain AI applications, pursuing FDA authorization and product-specific coding, coverage, and reimbursement can remain a highly attractive commercial path – and in some use cases, the most durable route to long-term scale.

Marwood Group
Marwood Grouphttps://www.marwoodgroup.com/
The Marwood Group is a healthcare-focused advisory and consulting firm headquartered in New York City with offices in Washington, D.C. and London. With a deep understanding of the influence policy, politics and market dynamics have on reimbursement, regulation, and business performance, Marwood Group supports their client’s investment decisions in assets across Europe and the United States. Marwood provides investors and operators with policy, regulatory, funding and reimbursement analysis, assessing the risk and opportunities that result from government action on the national or local level. A multilingual European team brings years of relevant healthcare expertise to every engagement.
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