The Food and Drug Administration (FDA) has granted 510K clearance to BioBeat’s wearable watch and patch for continuous monitoring of blood pressure, heart rate and oxygenation.
Both the smartwatch and patch work in tandem with cloud software and a mobile app, allowing patients and clinicians to view data in real-time. Patients can use one or the other device; the watch, which is intended for long period and repeated use, is worn on the wrist, while the patch, which works continuously up to 10 days, is placed anywhere on the upper torso.
Patients can also add data such as medication usage and timing of administration. The app adheres to current HIPAA regulatory requirements.
“Remote monitoring of patient’s vital sign requires completely different technological approaches than current practice,” says Biobeat’s Chief Medical Officer Prof. Arik Eisenkraft, MD. “While blood pressure, heart rate and oxygenation are the backbones of monitoring, we will continue to work with the FDA to approve additional parameters for our devices.”
The Company presented findings from a clinical study of 1417 volunteers at the 2018 Military Health Systems Research Symposium. The study found that the wireless wearable sensor achieved a 96% to 98% level of accuracy for blood pressure measurement.
For more information visit Biobeat.cloud.