Sources: Apple is developing an EKG heart monitor for Apple Watch
> — AliveCor's IP — A major FDA approval process for both the software algorithm (communicating yes or no to aFib) AND hardware — High risk of false positives outside of at-risk groups (over 65 population) http://www.bloomberg.com/... Ethan Weiss / @ethanjweiss : Nice story! I'd edit/amend my comment about no reason to use in asymptomatic/healthy people. There is not now a reason, but that does not mean there won't eventually be a reason which is why the one real reason to use now in asymptomatic people is for *research* http://twitter.com/... Thanks: @atbwebb
Context & Ripple Effects
The accessory path to Watch cardiology was proven first by others: Vic Gundotra's AliveCor spent 2016 waiting on regulators for its Watch heart-monitor band, and weeks ago its Kardiaband cleared the FDA as the first approved medical device accessory for the Watch. Apple has meanwhile been running a Stanford-partnered study collecting abnormal-rhythm data from a Watch app, alongside work with telemedicine firm American Well on detecting common heart conditions.
Building the EKG in-house rather than relying on accessories puts Apple in direct competition with AliveCor — with the report flagging AliveCor's IP as a live issue — and forces Apple through the same dual approval gauntlet: the detection algorithm and the hardware itself both need FDA sign-off.
First-order effects
- AliveCor's first-mover advantage as the only FDA-approved EKG option for the Watch evaporates if Apple ships its own sensor, shifting the contest to algorithms and the IP behind them.
- Apple must win two separate FDA approvals — software algorithm and hardware — before any aFib yes/no feature can ship, making regulator timing, not engineering, the gating factor.
Second-order effects
- High false-positive risk outside the over-65 at-risk group creates demand for the clinical backstop Apple has already lined up via American Well, since flagged healthy users need somewhere to take their alerts.
- Cardiologists like Ethan Weiss push back on screening asymptomatic people, so Apple's research framing — collecting data through the Stanford study before claiming diagnostic value — becomes the political cover for broad deployment.
Third-order effects
- If the pattern holds, consumer wearables become regulated medical devices by default, and platform owners like Apple internalize the sensor-and-algorithm stack that accessory makers like AliveCor pioneered — leaving third parties to fight over IP royalties rather than device slots.
- Population-scale cardiac screening shifts medicine toward watch-first diagnosis, a direction already visible in how some doctors use the Watch to help manage patient conditions despite dedicated FDA-approved devices existing.
The trend: Consumer wearables are crossing from fitness tracking into FDA-regulated diagnostics, with platform owners absorbing the medical-device layer that startups built first.