What Medtech Companies Can Learn From Apple's Virtual Clinical Study

Posted by Kate Templeton on March 21, 2019

The American College of Cardiology’s (ACC) Scientific Session and Expo, held March 16-18 in New Orleans, kicked off Saturday morning with the initial results of the much-anticipated Apple Heart Study. For those who keep pace with the fast-moving tech world, I’m sure it felt like an eternity since the study had been announced. But by healthcare standards, the study went quickly and accomplished something unthinkable: It enrolled a breathtaking 419,297 individuals in eight months using a novel, entirely virtual study design.


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Et Tu, FDA? Why Medtech Needs to Stop Feeling Betrayed by the FDA

Posted by Brian Chapman on October 31, 2018

For shame! How could the FDA approve a silly touch screen watch to do the job of serious cardiologists—and rush it through the approval process, too? How could a high-end stereo-equipment-maker suddenly become a supplier of medical devices? And then there’s the notion that this device could be fitted without the help of a qualified professional!


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The Apple Watch Wake-Up Call

Posted by Brian Chapman on September 20, 2018

By now, we’ve all heard the latest digital health news: Apple secured FDA clearance for its EKG app on the newest Apple Watch. The tech giants are coming! The end is near!


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