[rnavara]

Yes, you get it - it's a boring hospitalization all around! For patients getting a cardioversion after their drug-load, they can fortunately come get one as an outpatient (most cardioversions are for elective outpatients, and in fact the inpatients often get bumped for the scheduled outpatients). Hospitals are particularly happy about our workflow because they don't get dinged for readmissions - whether for cardioversions or for drug dose adjustments, which also require readmission under the current standard.

Phase I Software validation doesn't require clinicaltrials.gov registration, but our Phase II trial will be per FDA!

[carbocation]

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...