Tag Archives: Real world data

Kaushik Gune

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

By MedTech Intelligence Staff
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Kaushik Gune

This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.

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Jack Cronenwett, MD
Reimbursement Report

How Real-World Evidence Helps Medical Device Manufacturers Drive Value

By Jack Cronenwett, MD
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Jack Cronenwett, MD

More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.

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