“Submission... restarted using a retrospective EHR and lab data set... provided longitudinal follow-up of about three years and resulted in a successful approval”
♫
Said on FDA Watch
“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”
FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
Play from 13:42
13:42
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What was described
ran a pre-market regulatory submission for a thermal ablation catheter using EHR data from two health systems covering over 1,400 patients
1,400 patients
Said nearby on the same subject
“They're using de-identified patient data, we're going to be tracking to see whether doing these whole body MRIs actually improve health outcomes down the line”
♫
Said on The Readout Loud
“We just signed our 31st health system. We're in 13 states and two countries... white-labeled... gives these health systems the same sort of tech-enabled logistics experience.”
♫
Said on Pharmacy Podcast Network
“We have a system where we have two SMEs right now, including myself. We stay on top of this to make sure that all of our regulatory requirements are aligned with what's present.”
NC
Nick Coleman
Lawyerist Podcast ·
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