Ariel Stern

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.

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.

May 9, 2023 | jamanetwork.com | Alexander O. Everhart |Yi Zhu |Ariel Stern |Soumya Sen

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance—Reply In Reply Dr Rathi’s comments describe a fundamental challenge when studying 510(k) medical devices. Researchers can observe individual clearances, but when are devices actually different or new? Changes not related to device design that seem trivial ex ante could affect patient safety ex post.