I reckon CDX have been thinking it was an accessory to a class...

I reckon CDX have been thinking it was an accessory to a class II device originally, and the two ( Pulse and companion app ) would be submitted together to obtain the same clearance.

However, it may have been apparent to regulatory personnel in CDX and Andon that this may not be the case and the app may be ruled as MDDS ... a far better outcome for all future device development and FDA submissions ( such as the band, faster turnaround, easy to extend applications etc ) as they become unencumbered from the companion app. Worth taking a shot on submitting the app first at the cost of a delay to the Pulse submission

The key regulatory body has green lit the app as a non-device medical device data system (MDDS), as opposed to an accessory to a Class II medical device.

An accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. A parent device is a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.

In this case the parent device is the Pulse as the class 2 device, and the ConneQt App was thought to be the accessory.

As it turns out, the FDA ruling is that it is not an accessory device. So happy days. Now let's submit the Pulse FDA submission.

I could of course be completely wrong, but it sort of makes sense to me and gives a very valid reason for the delay