ECG

By Dave Muoio 01:08 pm September 5, 2019
RocketBody, an app for the Apple Watch that uses ECG data and machine learning to guide workouts, has raised $1 million in new funding from Gagarin Capital and AltaIR Capital. WHAT THEY DO RocketBody is the product of Kickstarter and IndieGoGo campaigns that raised roughly $70,000 for its pitch of a $109 ECG wearable back in 2018. The readings from this device would inform an artificial...
By Dave Muoio 02:31 pm September 4, 2019
Even more ECG. Electronics hardware company Asus pulled back the curtain on its latest health and fitness smartwatch today at IFA 2019 in Berlin. Engadget, TechRadar and others report that the VivoWatch SP includes a built-in ECG sensor alongside a PPG sensor, GPS tracking, an altimeter and roughly 14 days of battery life. The company is aiming for worldwide availability before the end of the...
By Dave Muoio 03:45 pm August 19, 2019
Update: This story has been updated to include additional comments from AliveCor.  Mobile ECG maker AliveCor has ended sales of KardiaBand, its FDA-cleared ECG wristband designed for use with Apple Watches, a representative of the company confirmed to MobiHealthNews today.  The company appears to have pulled down the device’s purchase page sometime after June 12, according to cached versions of...
By Dave Muoio 01:33 pm July 25, 2019
After months of treading water, mobile ECG maker AliveCor has finally named its new CEO: Priya Abani, who up until this point led the Alexa Voice Service for Amazon. Abani’s three years at Amazon as general manager for devices and enablement saw her spearheading integration efforts to integrate voice assistant with Amazon’s various connected services, as well as leading its product, engineering,...
By Dave Muoio 03:00 am July 17, 2019
Withings announced this morning that it is updating its connected blood pressure cuff product line with two new offerings: a revamped version of its existing at-home cuff, and a premium cardiac monitor with onboard ECG functionality. The former device is the Withings BPM Connect ($99.95/€99.95/£89.95), an FDA-cleared and CE-compliant consumer product for monitoring systolic pressure, diastolic...
By Dave Muoio 08:42 am May 13, 2019
Mobile consumer ECG maker AliveCor announced today that its long-teased six-lead ECG device has been cleared by the FDA and will be available to customers in June of this year. “[The KardiaMobile 6L clearance] is a big deal for us, and it’s important for patients and physicians because they will be able to get a materially improved view into patients’ hearts,” Dr. Jacqueline Shreibati, chief...
By Dave Muoio 01:37 pm 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,...
By Dave Muoio 03:21 pm 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...
By Dave Muoio 01:33 pm 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...
By Jonah Comstock 02:36 pm 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...