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High-Tech iPhone Case Is FDA-Approved EKG Monitor

Attachable device turns the iPhone 4 or 4S into a Class II heart monitor.

John Pugh, BI
John Pugh, BI on December 21, 2012. @johnpugh

What’s the nicest iPhone case you’ve ever seen? One with a nice screen-printed graphic? Something nearly indestructible, or perhaps one with a fancy camera lens? Well think again, because this one is sure to beat them all with its bells and whistles: A fully functional, FDA-approved heart monitor.

The AliveCor Heart Monitor is a $200 app and smartphone case combo that when held in your hands or pressed against your chest produces an EKG, those famous green blips that tell us whether a patient is going to live or die on hospital shows and movies. The case communicates wirelessly with the app, doesn’t require device pairing and sends patient data to a site that safely tracks and stores all EKG readings. Although there are many camera-based heart monitor apps already available, this is the only one that is up to federal and clinical standards, hence appropriate for actual medical use rather than casual wellness awareness. In development since 2010, the system had to pass several clinical trials under the FDA, one for the app and one for the case.

But why bother with FDA approval in the first place? Besides the legitimacy boost, it makes the iPhone case marketable to doctors who can actually use it to diagnose patients. Since traditional EGK machines are very expensive and bulky, the AliveCor system looks attractive as a mobile alternative. Furthermore, FDA approval also allows doctors to prescribe it for patients to take home. Problem is, the certified version only works for the iPhone 4 and 4S. Any system for the iPhone 5 or Android would require another time-consuming round of approvals.

Eventually AliveCor wants consumers to have access to high-grade medical devices of their own, part of their overall mission to put health in the hands of consumers. This iPhone case is meant to help patients understand health alongside their doctor, not to replace any existing measurements but rather deepen their understanding and insights to their own health.

Currently only available in pre-order for US medical professionals, this device could be revolutionary if made commercially available (AliveCor indicated an announcement regarding a consumer app in January). Because of its portability, patients could have their EKGs taken right away without being shuffled around a hospital. Outside of the clinic it would be enormously helpful for EMTs and paramedics, who could take readings on the streets or in homes. If a telecommunications ability were added it could help people reach emergency services after a dangerous reading.

Despite obstacles such as the FDA approval cycle and smartphones’ frequent updates, AliveCor is taking a strong step towards empowering consumers to be more aware about their health. If more complex medical devices are made so accessible and portable, it could save untold dollars and time spent waiting at hospitals for routine readings, and will empower patients to become more involved in their own health.

AliveCor

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