FDA Clears Cardiac Designs' Apple iPhone-Based ECG

Published: Mar 14, 2013

Utah medical device startup Cardiac Designs wins over-the-counter indication for its iPhone-based ECG monitor. Utah-based Cardiac Designs is still flying under the radar after having won FDA 510(k) clearance for its iPhone-based ECG monitor. The FDA nod may represent a win for consumers who are increasingly interested in recording their own health data, but the regulatory win comes with a strange restriction - patients must obtain a physician prescription in order to view the raw wave form data captured from the heart. The device is not yet on the market and the company hasn't announced its regulatory win, and the company website has little information beyond noting that the ECG Check iPhone cardiac monitor is "coming soon."

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