The US Food and Drug Administration (FDA) has granted 510(k) clearance to Biosign Technologies' non-invasive blood pressure measurement system, Pulsewave monitor.
The UFIT EN-10 monitor is worn on the wrist having 13.5 cm to 23 cm (5.3 in to 9.1 in) sizes and is used for measuring the systolic, diastolic blood pressure and pulse rate.
Incorporating computer controls and web services, the cuff is intended for patient use at home and by healthcare professionals in their practices, according to the company.
Biosign CEO Robert Kaul said with the FDA approval, the company can now implement its 2013 sales plan.
"With this announcement, our Pulsewave system now has regulatory approval for Canada , the European Union and the United States , which will represent a total combined market of over $1.7 billion by 2015," Kaul added.
