[moose_ears]

This topic is addressed by Grady Hannah, co-founder and CEO of NightWare, on the June 23 edition of the DTx podcast with Eugene Borukhovich.

FDA posted a PDF summary of its decision on this product here: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200033.p...

[jhanschoo]

Samsung Health deployed less-than-reliable blood pressure features in non-US markets while waiting (and in some cases not gettign) FDA clearance. I wonder if NightWatch and Apple may consider releasing the app in laxer markets. People who really need it will then have a gray market way to get access.