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...
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...
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...
Smartphone-connected ECG maker AliveCor is teaming up with the Mayo Clinic once again, this time to develop algorithms to screen for Long QT syndrome, a heart condition that can often cause sudden death, especially in children. The partnership also includes an additional, undisclosed investment in AliveCor from Mayo Clinic.
Long QT syndrome is named for the interval between the Q Wave and the T...
Personal MedSystems, a German medical device company better known by its brand name CardioSecur, has raised $5.36 million (5 million euros). KPN Ventures led the round, with additional contributions from new investors Sino-German High-Tech Fund and the NRW-Bank, and existing investors Seventure Partners and HTGF.
“The Series B financing and the strategic leverage points of our new investors will...
The ACT device paired with a previous phone.
LifeWatch, a Swiss remote cardiac monitoring company that has been connecting to mobile phones since 2009, has received FDA clearance for a new version of its Ambulatory Cardiac Telemetry (ACT) system that will run on Android devices. Currently, the system runs on Microsoft Windows phones. Patients use the mobile software to answer a couple...
It's been almost a year since AliveCor began offering its first FDA-cleared algorithm, its atrial fibrillation detection algorithm, to customers. Now the company has released some data on how customers are using the algorithm to detect atrial fibrillation.
According to AliveCor, 30 percent of AliveCor users have received a diagnosis of atrial fibrillation through the algorithm. More than half of...
Utah health system Intermountain Healthcare -- and other, as yet unknown providers -- appear to be investigating AliveCor's smartphone ECG device in a clinical context, to determine whether the iPhone version of the device is comparable with traditional 12-lead ECGs. The trial aims to test the device with 50 patients who have possible ST Elevation Myocardial Infarction (STEMI), a common type of...
Smartphone-enabled ECG medical device maker AliveCor and Greatcall, which makes a line of mobile phones and health services marketed to seniors, have partnered to bring the AliveCor device to GreatCall phones.
“Heart disease is the leading cause of death in the US, claiming about 1 million lives each year,” David Inns, CEO of GreatCall, said in a statement. “With access to an easy-to-use,...
AliveCor has received an additional FDA 510(k) clearance, this time for an algorithm that allows its smartphone ECG to detect atrial fibrillation -- an abnormal heart rhythm that isn't always detectable to the patient, but if left untreated can lead to stroke or congestive heart failure -- with high accuracy. The app is set to launch for consumers in September.
"Our pretty strong belief is that...
