Ariel Stern Journalist Profile

Articles

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway | npj Digital Medicine

Feb 7, 2024 | nature.com | Mateo Aboy |Ariel Stern

AbstractModerate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago.
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

Feb 2, 2024 | ascpt.onlinelibrary.wiley.com | Caroline Marra |Ariel Stern

WHAT IS CURRENT KNOWLEDGE ON THE TOPIC? Digital health technologies (DHTs) can enable more patient-centric therapeutic development by increasing trial inclusiveness, lowering participation burden, and capturing aspects of health that are meaningful to patients but cannot be easily measured using traditional data collection methods. Although DHT use in clinical trials overall has grown, uncertainty remains about how often DHTs are used in product development trials in particular.

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