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USCOM LIMITED — Regulatory Filings 2010
Apr 5, 2010
65979_rns_2010-04-05_79bf47ed-f99e-42b9-9707-ba7b1370b494.pdf
Regulatory Filings
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Uscom Limited ABN 35 091 028 090 Suite 1, Level 7, 10 Loftus Street Sydney NSW 2000 Australia T +612 9247 4144 F +612 9247 8157 www.uscom.com.au
M A R K E T A N N O U N C E M E N T
Canadian Regulatory Approval for USCOM
Tuesday 6th April 2010: Uscom (ASX code: UCM) today announced that it has received a Medical Device Licence for USCOM in Canada by the Medical Devices Bureau of Health Canada. This licence is a requirement for USCOM sales in Canada.
This now completes the USCOM worldwide regulatory approval programme which allows USCOM sales into the major world markets including US, China and Europe. Uscom’s marketing partner, Spacelabs, is responsible for the Canadian market and can now initiate Canadian sales activities. USCOM has been used in research activities in Canada and was evaluated by Canadian physicians at international meetings.
Rob Phillips, the Executive Chairman of Uscom and Director of Clinical Science said “Canada is a sophisticated and significant medical device market which has shown considerable interest in our technology, and this approval will allow Spacelabs to activate the regional sales process to take advantage of this interest. Additionally this approval now means we have regulatory access to the world’s major medical device markets, supporting the activities of our global marketing partners Spacelabs and Pacific Medical Systems.”
About Uscom
Uscom Limited is an Australian medical device company which was first listed on the Australian Stock Exchange in December 2003. Uscom has developed a Non Invasive Cardiac Output Monitor. The USCOM is a simple, cost-effective and non-invasive device that measures heart function, detects irregularities and guides treatment. The USCOM device has major applications in Paediatrics, Emergency Medicine, Intensive Care Units and Anesthesia, and is a tool of choice for management of adult and paediatric sepsis, and for the guidance of all fluid administration. USCOM has global regulatory approval and the technology is currently marketed in North America, South America, Europe, the Middle East, India and Australia by Spacelabs Healthcare, while in China and SE Asia USCOM is distributed by Pacific Medical Systems and in New Zealand it is distributed by MedXus.
Uscom Contacts
Rob Phillips Chief Executive Officer [email protected]
Daniel Fah Company Secretary [email protected]