Re:Launch HN: SafeBeat Rx (YC S21)- At-home ECG software to ...
by carbocation on Tuesday August 24, 2021 @05:59PM
(#28295511)
Thanks! Glad you've already considered the cardioversion workflow. If your system is good enough to do the load+monitoring safely at home, this sounds like a win-win.
Also, I didn't realize that Phase I trials didn't have to be registered on clinicaltrials.gov! But you're right, they're specifically exempted[1].
1 = https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrials...
Phase I Software validation doesn't require clinicaltrials.gov registration, but our Phase II trial will be per FDA!