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This $200 iPhone Case Is An FDA-Approved EKG Machine.

Most iPhone cases just protect your phone from drops. If you’re getting fancy, it may have a fisheye camera lens or a screen-printed back. But what about diagnosing coronary heart disease, arrhythmia, or congenital heart defects? The AliveCor Heart Monitor is an FDA-approved iPhone case that can be held in your hands (or dramatically pressed against your chest) to produce an EKG/ECG–the infamous green blips pulsing patient-side in hospitals everywhere.

“We think that EKG screening can be as approachable as taking blood pressure,” AliveCor President and CEO Judy Wade tells Co.Design.

There are already apps that take your heartbeat, of course. But there’s a big difference between the fast-paced standards of casual electronics and the strict sanctions of government-approved medical devices. “The heartbeat camera apps are good at wellness,” Wade admits, “but we see ourselves for use by people who want clinical-quality equipment.”

So unlike most iPhone cases that are squirted by Chinese factories at extremely high margins, AliveCor’s case has been in serious development since 2010. Aside from building the gadget itself, to become a approved for medical use by the FDA, AliveCor had to participate in two clinical trials to field test both the hardware and the accompanying app. One study investigated how its single-lead EKG compared to a traditional 12-lead device, the other examined if 54 participants could figure out how to use the case properly, with no previous medical training. The latter study was not only successful but led to the diagnosis of two serious heart problems.

Read the full article here.