Nicole Coustier
Nicole Coustier

Reimbursement Déjà Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry

By Nicole Coustier

Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.

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Penny Pinnock
Penny Pinnock

Unleashing AI Potential in Medical Imaging

By Penny Pinnock

Due to a shortage of radiologists and other imaging specialists, AI-enabled technologies are of significant interest—and hold particular promise—in medical imaging. In this article, Penny Pinnock of Siemens Financial Services (SFS), discusses the routes to investment available for healthcare organizations looking to acquire efficiency boosting technology while protecting their financial health.

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Artificial Intelligence Graphic
Artificial Intelligence Graphic

Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

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