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This U.S. FDA approval could be a huge deal for Apple

“When Apple Inc. released the Apple Watch Series 3 earlier this year, the company’s aspirations in the field of health became increasingly clear. The Apple Watch was described as ‘an amazing health and fitness companion’ and ‘the ultimate device for a healthy life,'” Danny Vena writes for The Motley Fool. “Several other recent developments point toward a broader entry into personal health, and there’s mounting evidence that this could be Apple’s next big growth area.”

“The U.S. Food and Drug Administration has approved the first medical device accessory for the Apple Watch, the KardiaBand electrocardiogram (EKG) reader by med-tech start-up AliveCor,” Vena writes. “The KardiaBand replaces the original watchband and combines a sensor with an artificial intelligence (AI) app that can detect an abnormal heart rhythm or atrial fibrillation (AFib). This could be the first step of potentially a massive opportunity for the iPhone maker — the healthcare market.”

“The FDA has already enlisted the help of Apple as one of nine companies chosen to participate in a pilot program that seeks to accelerate the process for approving software-based devices and medical apps. The regulator has been reviewing its approach to technology as part of its Digital Health Innovation Action Plan, with plans to ‘modernize the regulatory framework’ and reduce the amount of red tape necessary for the approval of these apps and devices,” Vena writes. “This could be the start of something big.”

Read more in the full article here.

MacDailyNews Take: There’s Apple Watch, a sophisticated, secure wrist-borne computer with the backing of major hospitals, medical researchers, insurance providers, and more. And, then there’s a bunch of toy stupidwatches. The Apple Watch wannabes are roadkill.

SEE ALSO:
AliveCor’s Kardiaband EKG reader becomes first Apple Watch accessory to win FDA approval as a medical device – November 30, 2017
Apple Heart Study launches to identify irregular heart rhythms – November 30, 2017
AliveCor’s Kardiaband EKG reader becomes first Apple Watch accessory to win FDA approval as a medical device – November 30, 2017
Apple Heart Study could turn Apple Watch into a ‘must have’ for millions of patients – September 12, 2017
Apple Watch the most accurate heart rate monitor in new fitness tracker study – May 24, 2017
Apple Watch helps doctors detect the leading cause of heart failure with 97% accuracy – May 12, 2017
Apple patents advanced heart rate monitor for Apple Watch – October 6, 2016
Apple Watch heart rate data vs. Mio dedicated heart rate monitor – May 7, 2015

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