“Study leveraged EHRs from two health systems, over 1,400 patients and was believed to be one of the first PMA label expansions based solely on EHR data”
♫
Said on FDA Watch
“Submission... restarted using a retrospective EHR and lab data set... provided longitudinal follow-up of about three years and resulted in a successful approval”
FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
Play from 14:47
14:47
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What was described
restarted a stalled in-feature diagnostic submission using a retrospective EHR and lab dataset providing ~3 years of longitudinal follow-up
3 years longitudinal follow-up
Said nearby on the same subject
“Patterns using LLM analysis… AI comes up in roughly one of five submissions”
TF
Tim Ferriss
The Tim Ferriss Show ·
“I provided in the first year, a year ago, 55 million meals, and then provide the matching funds to feed 100 million through Feeding America.”
TR
Tony Robbins
Tony Robbins Podcast Daily ·
“We use LLMs to conduct document reviews… so that all submissions include 100 percent of required criteria with no administrative errors”
♫
Said on In The Trenches
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