Omron wins FDA nod for combined blood pressure monitor, EKG

Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release.
The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke.
The newly cleared device is designed to sync with the Omron Connect mobile application to store, track and share heart health data with physicians to improve outcomes, the company said in its original product release.
The combined product, under the moniker BP7900, was cleared by the FDA earlier this month after being found substantially equivalent, according to the FDA release.
Last December, Omron launched its HeartGuide wearable blood pressure monitor, touting it as the world’s first device of its kind.
The post Omron wins FDA nod for combined blood pressure monitor, EKG appeared first on MassDevice.

Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance AliveCor Omron Source Type: news