Biosign Technologies Inc. Receives FDA Pre-Market Clearance for Biosign Pulsewave Monitor
Published: Dec 04, 2012
The specific wording of the 510(k) clearance is as follows: "The UFIT•TEN•10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient use at home and by healthcare professionals in their respective practice. The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in)."
This critical regulatory approval clears the way for sales of the Pulsewave™ Monitor product line to both Healthcare Providers and Consumers in the world's largest market for medical devices. As a computerized blood pressure monitor, Pulsewave™ will compete with other automated, clinical grade BP monitoring products. Frost & Sullivan estimates that by 2015, the total US Market for BP monitors will exceed $1.1 billion , split between approximately $300 million in the professional market and approximately $800 million in the home market [source: "Assessment of North American and European Markets for Blood Pressure Monitoring and Telehealth" Frost & Sullivan, April 8 , 2011]. As a primarily software-driven Cloud Diagnostics™ solution, the Pulsewave™ system is uniquely positioned to compete successfully in both arenas, since results can be customized for each audience.
Biosign CEO Robert Kaul stated: "This regulatory approval is a cornerstone to our 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 [source: Frost & Sullivan, April 8, 2011 report]. Our goal now is to capitalize on our distribution relationships in all three regions to meet our corporate sales requirements in 2013 and beyond."
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SOURCE: Biosign Technologies Inc.
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Phone: (416) 218-9800 ext. 201