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 technology and was announced at the same time.
According to the 2018 announcement and a fact sheet on Omron's website, the Blood Pressure Monitor + EKG offering is a home monitoring device that purports to be the first to measure for both high blood pressure and atrial fibrillation, two different risk factors for stroke. Weighing just over a pound, the device displays readings on a screen and can also send them to the Omron Connect app. (According to AliveCor's website, its Kardia Mobile device can also now integrate with the Omron Connect app.)
"We’re constantly looking at the market to see what’s out there, what technologies are there, and seeing how we can combine our technology with someone [else’s] technology in pursuit of going for zero [deaths from heart disease],” Ranndy Kellogg, president and CEO of Omron Healthcare, said during the original announcement of the device at CES in 2018. “Omron is creating the first blood pressure monitor for use at home that also measures EKG. Up to 6 million people have a-fib. These people are at a five times greater risk of stroke than those without a condition. This is a partnership with AliveCor that’s led to a breakthrough, this home blood pressure monitor with EKG."
According to Omron, the product will be available for sale starting May 1, with pre-sale beginning on April 15 at OmronHealthcare.com.
AliveCor has also been busy
AliveCor also just recieved a new, and possibly related, FDA clearance for something called KardiaAI. That clearance could also be related to AliveCor's upcoming Kardia Mobile Gen 2 six-lead device. The company declined to comment.
At the American Conference of Cardiologists meeting last week, AliveCor presented a number of different research studies, including one that tested the Gen 2 device at the Mayo Clinic and found it could accurately measure the QT interval, a measure associated with sudden cardiac death. Another study looked at the effect of KardioPro, the company's new remote monitoring platform, on documentation and treatment decision-making when integrated with EPIC.
Finally, a recent RCT in the Lancet's EClinical Medicine journal showed that UK doctors using KardiaMobile increased the number of patients with palpitations and pre-syncope in whom an ECG was captured during symptoms over five-fold to more than 55 percent at 90 days.