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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)

“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)

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)

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. (Nellis and Randewich, 9/13)

The device’s new health features are sure to increase Apple’s dominance of the smart watch category — and they underscore the company’s focus. When the watch was first released, critics and consumers were confused about its utility. Over time, Apple has refined the device to focus on its health and fitness capabilities. Now the narrative is clear: Get this watch, if you want to live. (Chen, Nicas, Manjoo and Abelson, 9/12)

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)

Apple assured the audience at Wednesday's event that the data captured by the watch are encrypted, both on the device itself and in the cloud. But the ECG capability nevertheless brings up new questions about privacy, said Angela Radcliffe, general manager of clinical trial solutions for PulsePoint. For instance, consumers may one day be able to monetize their health data, she said. "Healthcare consumer data might be the next part of the gig economy." (Arndt, 9/12)

Hadeel Ayoub slips a black glove onto her hand before beginning the swish of sign language that is meaningless to the untrained observer. Then she pushes a button on her wrist, and a small speaker relays the message drawn in the air: “Let’s Dance!” “My dream is to give a voice to those who can’t speak,” says the 36-year-old inventor who is developing her BrightSign glove while working toward a Ph.D. in assistive technology at Goldsmiths, University of London. (Kirka, 9/13)