Apple’s COO Jeff Williams exuberantly proclaimed Apple’s Watch was the first to get FDA clearance as an over-the-counter electrocardiogram (EKG) reader during the special event at Apple headquarters on Wednesday. While Apple loves to be first to things, that statement is false.
AliveCor has held the title of first since 2014 for its KardiaMobile device, a $100 stick-like metal unit you attach to the back of a smartphone. Ironically, it also received FDA clearance for the Kardiaband, an ECG reader designed to integrate with the Apple Watch and sold at Apple stores late last year. Just this week, the FDA gave the go ahead for AliveCor’s technology to screen for blood diseases, sans blood test.
However, the Apple Watch could be the first to matter to a wider range of consumers. For one, Apple holds a firm 17 percent of the world’s wearables market, with an estimated shipment volume of 28 million units in just 2018. While we don’t know how many AliveCor Kardiaband and KardiaMobile units were sold, it’s very unlikely to be anywhere near those numbers.
For another thing, a lot of people, even those who suspect they have a heart condition, might have some hesitations around getting a separate device just to check. Automatic integration makes it easy for those curious to start monitoring without needing to purchase any extra equipment. Also, while heart disease is the number one killer in the U.S. and affects a good majority of the global population, most of us probably aren’t thinking about our heart rhythm on a daily basis. Integrating an EKG reader straight into the Watch makes monitoring seamless and could take away the fear some may have about finding out how their heart is doing.
Then there’s the Apple brand, itself. Many hospitals are now partnering with Apple to use iPads and it’s reasonable to think there could be some collaboration with the Watch.
“Doctors, hospital systems, health insurers, and self-insured employers don’t want to manage separate partnerships with each of Apple, Xiaomi, Fitbit, Huawei, Garmin, Polar, Samsung, Fossil, and every other wearable manufacturers. They need a cross-platform product that works for all of their patients,” Cardiogram founder and EKG researcher Brandon Ballinger told TechCrunch. “So if Apple becomes the Apple of healthcare, then a company like Cardiogram or AliveCor can become the Microsofts of this space.”
How does this announcement from Apple affect AliveCor? CEO Vic Gundotra shrugs it off. He tells TechCrunch the vast majority of AliveCor’s business is from KardiaMobile, not it’s Apple-integrated ECG reader. “Apple has long alluded they were building something like this into the device,” Gundotra said, “so we’ve been anticipating it.”