Apple Shoulders Into Health Landscape With Revamped Watch That Is FDA-Approved To Measure Heart Rhythms
The device will be the first electrocardiogram ever to be available over the counter. Apple's pivot toward a health care focus for the wearable comes after struggling to convince customers that they need the watches.
The Associated Press:
The Apple Watch Is Inching Toward Becoming A Medical Device
Apple is trying to turn its smartwatch from a niche gadget into a lifeline to better health by slowly evolving it into a medical device. In its fourth incarnation, called the Series 4 and due out later this month, the Apple Watch will add features that allow it to take high-quality heart readings and detect falls. It's part of Apple's long-in-the-making strategy to give people a distinct reason to buy a wrist gadget that largely does things smartphones already do. (Liedtke, 9/13)
Los Angeles Times:
Apple Unveils Big, $1,099 IPhone XS Max And Pitches Upgraded Apple Watch As Health Device
“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” FDA Commissioner Scott Gottlieb said in a statement. Healthcare products on ubiquitous devices, such as smartwatches, may help users seek treatment earlier and empower them with more information about their health, he said. (Gurman, 9/12)
Stat:
The New Apple Watch, With FDA's Blessing, Comes With An EKG App
Theirs is the first electrocardiogram ever to be available over the counter, Apple’s COO Jeff Williams said. The Apple Watch Series 4 will cost at least $399. Apple wasn’t the only one bragging about the move Wednesday. FDA Commissioner Scott Gottlieb also jumped in to tout his agency’s role in the clearance.
(Sheridan, 9/12)
The New York Times:
Apple Unveils Bigger IPhones At Higher Prices, And A Heart-Tracking Watch
Apple has long had a playbook for iPhones, its most important product: Keep rolling out bigger, faster and more expensive models. On Wednesday, it repeated that strategy by introducing another round of iPhones that are — you guessed it — bigger, faster and more expensive. ...More notable, perhaps, was how much Apple is now evolving its smart watch into a clearly health-related device. The company showed off a new Apple Watch with an electronic heart sensor approved by the Food and Drug Administration. That could lead to new implications for health care — and prove to be a major selling point for a device that has played second fiddle to the iPhone. (Chen, Nicas, Manjoo and Abelson, 9/12)
Reuters:
Apple IPhones Get Bigger And Pricier, Watch Turns To Health
It is positioning the new watch as a more comprehensive health device, able to take an electrocardiogram to detect an irregular heartbeat and start an emergency call automatically if it detects a user falling down, potentially appealing to older customers. The U.S. Food and Drug Administration said it worked with Apple to develop apps for the Apple Watch and has been taking steps to ease the regulatory pathway for companies seeking to create digital healthcare products. (9/13)
The Wall Street Journal:
Apple Adds Heart-Monitoring, Fall-Detection Features To Its Watch
The Apple Watch ECG “could be beneficial to lots of patients” by picking up intermittent rhythm problems, said C. Michael Valentine, president of the American College of Cardiology and a cardiologist with Centra Medical Group in Lynchburg, Va. Yet doctors also raised concerns about potential risks from relying on the app. Dr. John Mandrola, a cardiac electrophysiologist in Louisville, Ky., said the ECG feature could misdiagnose patients because of inaccurate readings, or lead to overtreatment of patients. The watch may also detect cases of low-risk atrial fibrillation that don’t need to be treated, said Eric Topol, a cardiologist and director of the Scripps Translational Science Institute. This could lead to unnecessary prescriptions for blood thinners that carry bleeding risks, he said. (Loftus and Mickle, 9/12)