Signal Ring just announced a $399 ring that reads blood pressure continuously with no cuff and no need to calibrate. A first — if it works. Prompted me to look at where we are with current efforts at BP on wearables from Huawei, Samsung, Hilo, and Apple. Bottom line: no cuff-less device has been validated for continuous use, including Signal Ring.

One year after analyzing FDA’s AI medical device approvals, a new dataset confirms: growth continues, but acceleration is absent. While more young companies are joining the field, older firms like GE still dominate approvals—classic sustaining innovation. And Big Tech? Still barely on the board.

FDA approvals of AI-enabled medical devices are accelerating—but not in the way you might expect. While new startups are entering the space, the real winners remain legacy giants like GE and Siemens. An analysis of the latest FDA data reveals a classic case of sustaining innovation, not disruption, as established players integrate AI to reinforce their dominance.