TORONTO, Dec. 4, 2012 /CNW/ - Biosign Technologies Inc. (TSXV: BIO) (the "Company") is very pleased to announce that it has received
official notification from the US Food & Drug Administration,
confirming that the Company's UFIT TEN-10, now branded the Biosign Pulsewave™ Monitor, has been granted Section 510(k) clearance for sale in the United
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."
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.
SOURCE: Biosign Technologies Inc.
For further information:
Biosign Contact Information
Chief Executive Officer
Phone: (416) 218-9800 ext. 201