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With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions. Read More
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and a half years indicate the answer is yes. Read More
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The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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