AliveCor said today it is premiering the Kardia Band EKG-equipped band for Apple‘s (NSDQ:AAPL) Apple Watch, designed to provide diagnostic-grade electrocardiogram readings through a smartphone-connected app, as well as a significant update to the company’s existing EKG-monitoring app.
The Kardia Band is a thin wrist band designed specifically for the Apple watch that returns single-lead EKG readings and diagnostics that can be viewed through its app and sent to managing physicians, CEO Vic Gundotra told MassDevice.com in an interview.
“We built an EKG machine so small it fits inside the band of a watch,” Gundotra said. “The form factor allows you to, in a very discrete way, to reach over, touch the band and do a single EKG. It’s kind of breathtaking.”
Despite the smartphone connection and wearable nature of the device, chief commercial officer Doug Biehn said the company isn’t targeting the wearable fitness tracker market, but looking to develop into a growing field of wearable medical devices.
“We are not a fitness tracker like a Fitbit. It’s not the place we live. We’re also not your classic med device solution as well. What we’re calling ourselves is more ‘Wearable Med Tech’. We’re patient friendly, convenient, personal and provide real time data over the cloud that connects the patient with the provider in a more efficient and effective way than any of the alternatives,” Biehn told MassDevice.com.
While the device won’t compare in terms of data collected to a larger, multi-lead clinical model, Gundotra said it does provide high-quality single-lead ECG data.
“A multi-lead EKG will give you more data for other kinds of issues beyond A-fib. And that’s extremely valuable,” Gundotra said. “Our device is, of course, world class at detecting the kinds of arrhythmias you can detect with a single lead device, but there’s other significant improvements as well.”
The watch band-mounted EKG also provides a functional solution to its alternatives, which are antiquated, Biehn said. Alternatives include a halter monitor that can only be worn up to 48 hours and requires multiple leads attached to the body while wearing, and a patch that is worn for 2 weeks before being mailed and processed and reported to the managing physician, but not the patient.
“We are about providing patients real time information to improve early detection and get them engaged in the health care system earlier to save lives and give them piece of mind they can’t get with other current technologies,” Biehn said in an interview.
The company is seeking the same indications for the Kardia Band that it has for its AliveCor Mobile EKG, which attaches to the back of smartphones and can be used to provide EKG readings on request.
“You can really think of the Kardia Band as our existing product, just in a new miniaturized form,” Biehn said.
The company also announced updates and rebranding of its app, previously known as AliveCor Mobile EKG, to Kardia Mobile. The updated app will allow users to record voice messages along with their EKG readings so managing physicians can receive audio updates on the users’s physical status in addition to the heart data.
The audio recording will also allow the company to develop a system that could better predict physical condition based on a wealth of data in the recording, including tone, inflection and other voice signals, Gundotra said.
“Over time, not tomorrow, but over time, we expect to be able to extract more signal out of that human voice. We’ve got a whole bunch of things we’re working on that will allow us to do some pretty extraordinary things in the future,” Gundotra told MassDevice.com. “We looked at all these activity trackers, weight trackers, all these tools designed to help you with your health, and frankly, including our own application. We realized we forgot to ask the most basic of questions. It turns out, when people tell you how they’re feeling, in that voice signal there’s a lot of data. If you think about someone you love, you can often tell their sick just by their voice, you can tell if they’ve had a bad day. And yet, all that signal in the human voice is thrown away because no one ever asks for it.”
The newly updated app will also be able to correlate the EKG readings with Apple’s baked in HealthKit. Gundotra said the addition will allow users to track relationships between multiple health metrics and EKGs, and make it easier to track events like atrial fibrillations that are correlated with physical activities and other conditions.
Gundotra said the company had spent a significant amount of time not only getting the device, but also the algorithms that determine normal sinus rhythm, cleared by the FDA.
The company’s Kardia Band has not yet won FDA 510(k) approval, but the company will be showing off the device’s functionality today.