“‘We want to make the market for consumer medical products accessible to nontraditional manufacturers, or traditional technology manufacturers that haven’t before entered the medical space,’ U.S. Food and Drug Administration Commissioner Scott Gottlieb said in an interview at Bloomberg headquarters in New York on Thursday,” Tozzi reports.
“The FDA approved [Apple Watch Series 4] under a lighter-touch regulatory approach that didn’t require the agency to ‘rip apart the watch,’ Gottlieb said. Instead, the regulator focused on whether the software provided valid information to consumers,” Tozzi reports. “The FDA is talking with other companies about putting new consumer medical products on the market through the same approach, Gottlieb said.”
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MacDailyNews Take: We cannot wait to see how Apple Watch Series 4 ECG performs and if the benefits outweigh the drawbacks overall.