May 2, 2019
The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias.
According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias,...
April 25, 2019
The last couple of months saw a pair of regulatory clearances from mobile ECG maker AliveCor surface on the FDA’s 510(k) premarket notification database — the first in March for something called KardiaAI, and the latter a dual-update for the company’s existing KardiaMobile and KardiaStation platforms for consumer and point-of-care use.
With AliveCor keeping mum at the time, MobiHealthNews...
April 15, 2019
Another recent update to the FDA’s 510(k) premarket notification database suggests that AliveCor is inching closer and closer to its next volley of smartphone-connected ECG products.
According to the agency, the digital health company received clearance related to its consumer KardiaMobile platform, as well as the clinician-facing KardiaStation, on Friday. The application for the device or...
March 21, 2019
This article has been updated with a new photo and additional information from Omron.
Omron has apparently finally received FDA 510(k) clearance for its Blood Pressure Monitor + EKG device, which was originally announced in January 2018 at CES. The device was created in partnership with AliveCor. This is a separate product from Omron's HeartGuide watch, which also incorporates AliveCor ECG...
March 11, 2019
Belfast-based B-Secur has raised €4.7m (£4m) in Series A funding from existing investors Accelerated Digital Ventures and Kernel Capital. This brings their total funding to €11.7m (£10m).
What they do
B-Secur, whose HeartKey algorithms made a splash this year at CES, is looking to use ECG monitoring in a dual role: both for health and wellness purposes and for biometric identification.
March 4, 2019
A&E departments in the UK should introduce AliveCor’s KardiaMobile device into standard care, researchers have said, for patients presenting with heart palpitations or feeling lightheaded, after a study found it was five times more effective than current tests used to diagnose heart rhythm problems.
Although often harmless, if patients fully recover before getting to A&E, detecting the...
February 28, 2019
Toronto-based CardioComm, a longtime player in the handheld personal ECG space will finally make data available on consumers' smartphones with a new 510(k) clearance for its GEMS Mobile smartphone app, which works on both iOS and Android devices. The company also received clearance for a new ECG device called HeartCheck CardiBeat.
Notably, these are over the counter clearances, allowing the app...
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...