Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MIMS Today, in “Apple Watch: Fast-Tracking Medical Tech with Its Heart Rate Monitor,” by Leon Kan.

Following is an excerpt:

Finally, the Apple Watch requires FDA approval before it can be first considered to be a medical screening tool. All of this brings us back to the first hurdle regarding accuracy. Apple may include the most technologically advanced array of sensors and algorithms but, it would be all for naught if the data is not accurate. Currently, the gold standard for diagnosing heart disease is an ECG machine which measures the electrical impulses of the heart. Compared to that, the Apple Watch’s heart rate sensor has a hard time competing, as explained by Bradley Merrill Thompson, an FDA expert with the law firm Epstein Becker & Green, “A heart rate sensor would have a very difficult time demonstrating the level of reliability and accuracy necessary for a diagnostic claim.”

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