FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.
The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
Medical Device Network on MSN
FDA removes patient-identifiable RWE requirement for device submissions
The FDA’s change opens the door for RWE gleaned from de-identified data sources to be used for device submissions to the ...
FDA Commissioner Dr. Marty Makary announces the acceptance of broader real-world data in medical applications, ending ...
RejuvaCare Reports Growing Consumer Interest in At-Home Heated Knee Support as Seasonal Joint Discomfort Prompts Search for ...
For the first time, scientists have demonstrated how tanning beds cause fundamental DNA damage across almost the skin's ...
Comprehensive analysis examines the 40Hz gamma wave audio program, its neuroscience research foundation, and how it compares to supplements, brain training apps, and other cognitive wellness approache ...
Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary ...
Stockhead on MSN
Health Check: No longer sheepish, Opthea flags fresh start
After its disastrous phase III eye disease trials, Opthea will repurpose its lead asset to treat a rare lung disease the ...
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