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The recent glut of AI-fueled dermatology apps claiming to help consumers diagnose, track or treat skin conditions actually lack supporting evidence and don’t offer input from clinicians or dermatologists, according to a study published in JAMA Dermatology. Read More
Digital health technologies are uniquely effective tools for screening, diagnosing, and managing both type 1 and type 2 diabetes, according to stakeholders who commented in response to the FDA’s request for input on digital health technologies (DHT) for detecting prediabetes and undiagnosed type 2 diabetes. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Read More
A peer-reviewed analysis of data from a previous study of Masimo’s pulse oximetry device shows accurate measurement of oxygen saturation (SpO2) regardless of skin tones or pulse strength. Read More
AdvaMed has urged Congress to pass the Tax Relief for American Families and Workers Act of 2024 (H.R.7024) that contains a tax change that would allow businesses to deduct their research and development expenses in one year instead of over five years. Read More
This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices, drug distribution partners going all-electronic and seeking input on pulse oximeter discrepancies. Read More