February 25, 2019
With the addition of FDA clearances for the ECG sensor and irregular heart rate algorithm, the Apple Watch is now technically a medical device. But it is still primarily a consumer product, and its fitness features may still have the greatest impact on people’s health, according to a panel of health professionals — three doctors and celebrity trainer Jeanette Jenkins — who spoke at a recent event...
February 14, 2019
Smartphone-connected ECG maker AliveCor has officially named an interim CEO, shortly after securing $20 million in debt funding from Oxford Finance. Ira Bahr, the new interim CEO and former chief commercial officer, told MobiHealthNews that the company is gearing up for a big year in 2019.
“I think we’re going to do more in the next six months than we have in the last six years,” he said. “That...
January 17, 2019
Earlier today, Johnson & Johnson announced plans for a multi-year research program it will be launching with Apple to explore the role Apple Watches could play in senior health monitoring.
Set to kickoff later this year, the pragmatic randomized controlled trial study will be conducted in the US and enroll adults aged 65 years or older, according to a statement. Specifically, the primary...
December 18, 2018
Wearable data is becoming more integrated into clinical practice, but there is one caveat, explains Sense2beat CEO Natalia Glazkova — those devices can be contaminated by a glut of data.
Sense2beat is a Russian company working on technology that eliminates interference and analyzes ECG data.
“Data that comes from wearable devices is always contaminated by noise, which can make the analysis and...
November 12, 2018
New data from an international study of AliveCor’s smartphone app and accompanying two-wire ECG found the mobile tool to be on par with a standard 12-lead ECG among patients presenting with ST-segment elevation myocardial infarction (STEMI).
In the study — which was conducted in conjunction with AliveCor and presented this weekend at the American Heart Association’s 2018 Scientific Session in...
September 12, 2018
Well, we finally know what cardiac project Apple was talking with the FDA about two years ago. Apple Chief Operating Officer Jeff Williams announced today at Apple's special event in Cupertino that the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the company's Series 4 Apple Watch, due to start shipping September 21. ...
November 30, 2017
AliveCor has launched (and received FDA clearance for) a new ECG sensor built into an Apple Watch strap, as well as an Apple Watch app on which users can see their ECG in near real-time.
The strap, called KardiaBand, is an upgraded version of a product that launched in Europe last year. But in addition to the band, AliveCor is launching SmartRhythm, a software that continuously measures heart...
November 29, 2017
Austin, Texas-based semiconductor producer Silicon Labs has announced a new line of optical biometric sensors that promise more fleshed out heart rate monitoring and lower power consumption for consumer-grade wearables. By combining optical heart rate monitoring alongside ECG measurements within a single unit, the company says their new Si117x and Si118x sensor modules offer an easier way for...
November 13, 2017
A number of digital health devices have recieved FDA 510(k) clearance in the last month, including a number of apps and devices in the cardiac health space. Some clearances are updates to companies that have one or more existing clearances, while some are newly cleared devices. Read on for a roundup of connected ECG sensors, medical device companion apps, and wearable patches.
1. St. Jude Medical...
October 6, 2017
New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the device has the smaller on-body footprint of any wearable, multi-channel ECG with water-resistant electrodes.
“The 510(k) clearance of our Peerbridge Cor ECG monitor is an exciting milestone and the...