AliveCor on the up with $65m investment and FDA approval

The expanded investment by OMRON into AliveCor builds on the companies’ ongoing collaboration. In 2019, OMRON worked with AliveCor to expand its blood pressure monitoring portfolio with the launch of Complete, the first blood pressure monitor with ECG capability in a single device.

Complete is currently only available for purchase in the US, but further expansion is expected in other regions globally during the company’s fourth quarter.

More than one billion adults worldwide are thought to be hypertensive, and their risk of stroke is nearly five times greater if they also suffer from atrial fibrillation. The ability to monitor both blood pressure and heart rhythm at home is essential for early detection, treatment and management of all of these conditions.

Not only are cardiovascular conditions the number one cause of deaths worldwide, they’re also known risk factors for severe Covid-19. Technologies such as those developed by OMRON and AliveCor’s partnership are thus increasingly vital as the pandemic continues.

To date, AliveCor’s products have served more than one million customers worldwide and recorded over 85 million ECGs. The company’s algorithms were previously approved for the detection of atrial fibrillation, as well as determining whether the heart is beating too fast or too slow.

Now, the company’s new 501(k) clearance authorises its Kardia AI V2 portfolio for a wide range of further indications. AliveCor plans to launch the programs commercially next year as the foundation of a new range of telehealth offerings, aiming to target both home-based care and remote monitoring as well as launching clinician-focused products.

The programs are now able to detect ectopic heartbeats within a sinus rhythm, which signal premature contractions within the ventricles or atria of the heart that are out of sync with the chambers, and can sometimes cause the organ to skip a beat.

It can also measure a sinus rhythm with supraventricular ectopy such as premature atrial contractions, heartbeats that originate in the top chamber of the heart but not in the heart’s natural pacemaker, the sinus node. Alongside this, it is able to detect sinus rhythms with wide QRS intervals of 120ms or longer, which indicate that the bottom chamber of the heart is taking longer to activate than it should.

The new suite also boasts several improvements on the pre-existing model, such as reducing the number of unclassified readings; providing greater sensitivity and specificity; and new visualisations including average heartbeat and a tachogram.