Tag Archives: Real world data

Kaushik Gune

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

By MedTech Intelligence Staff
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
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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Jordanna Jayne

Realizing the Promise of Real-World Evidence in MedTech

By Jordanna Jayne, Ph.D.
Jordanna Jayne

Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.

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