heart rate monitor
The company also has pending approvals for the device in Australia and Thailand.
The heart rate monitor, which retails for $90, is worn around the forearm, unlike the company's other chest band wearable.
The consumer app enables users to monitor their own heart rhythm round the clock.
Biobeat's connected remote monitoring device is currently available as either a wristwatch or an adhesive patch.
The announcement has drawn questions about novelty and claims of coziness with the FDA.