The Index BPM is FDA-cleared, which means the producer can show that the product is “essentially identical” to a similar and legal market device with either FDA clearance or the gold standard FDA approval. Concurrently, competing health business Withings revealed in 2011 its first blood pressure monitor capable of linking to an iPhone. Withings has now developed many different versions of smart blood pressure monitors, including the similarly FDA-cleared Withings BPM Connect. So, although this is Garmin’s first effort at a dedicated smart BPM gadget, it isn’t exactly breaking new ground.
