Cardiac Designs, a medical device manufacturer based in Utah, received 510(k) clearance from the United States Food and Drug Administration for its iPhone ECG monitor. While this marks a positive for the company, Cardiac Designs is maintaining a low profile for now.
Many consumers have an increasing interest in recording their own heart rhythm data. While the regulatory win may benefit these consumers, the 510(k) clearance comes with an unusual caveat. To view the raw waveform data captured from their hearts, patients will be required to obtain a prescription from a physician.
As of now, the device is not yet on the market. The company’s website simply states that more information is “coming soon.”
One of the company’s rivals, AliveCor, is attempting to overturn the raw data restriction that plagues Cardiac Devices’ iPhone heart monitor. Last week, AliveCor’s AliveECG heart monitor was used by a physician during a flight to diagnose a patient experiencing abnormal heart rhythms. In 2011, the device was used during a flight for a rapid diagnosis of a patient experiencing a heart attack.
The AliveCor device has not received over-the-counter clearance from the FDA. Instead, a physician must prescribe the heart monitor for use by a patient. The company is hoping for OTC approval in the later half of 2013.