Healthcare DIVE August 7, 2023
Fall is coming – and so is regulation for digital health products. This spring, the CDC officially ended the United States’ pandemic “public health emergency,” which means that companies who received emergency exceptions for their products will have to remove them from the market if they don’t get them FDA-cleared by early November.
This is no abstract threat: earlier this summer the FDA sent a stern warning letter to iRhythm for overstating the scope of use for one of their wearable heart monitors. That action sent iRhythm’s stock price tumbling, showing that even a market leader like them will have trouble if they’re not diligent about staying in compliance.
In general, the recent digital-health explosion – from smart-trackers to decision...
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