The high-risk wellness paradox of brain-stimulation wearables
Under EU MDR, a brains-stimulation headset treating depression is Class IIa. The same headset marketed for focus or relaxation, with no medical claim at all, is Class III — the highest risk tier there is. A look at the regulation behind this inverted logic.
Wearables in the race for ovulation accuracy
While a lawsuit questions Oura's sleep-tracking claims, its ovulation-prediction accuracy is quietly outperforming expectations — and so are Apple's and Huawei's. None of them hold medical device status for it. Natural Cycles does but has not published such data. What that gap actually reveals about evidence strategy for FABMs medtech vs wellness products.
