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“CDRH clearance is neither necessary nor sufficient for CDER to accept a cough monitor as a trial endpoint. The two run on independent tracks.”
“CoughPro passively captured 23,445 hours of real-world cough from 206 coughers, then layered structured survey data on top.”
“An estimated ~100 million people worldwide suffer from RCC, yet no FDA-approved therapies exist. ”
“Despite the widespread use of cough-counting technologies, no system has yet received explicit FDA clearance for counting coughs.”
