USCOM gets FDA green light
Wednesday, 16 February, 2005
Sydney heart monitor firm USCOM (ASX:UCM) has received regulatory approval from the US Food and Drug Administration, allowing it to market its devices in the states.
The company had submitted its 510K application in November 2004.
USCOM chief executive Gary Davey said the company already had regulatory clearance and first sales in 11 other countries, including Australia. USCOM said its cardiac monitor uses ultrasound technology to cost-effectively and non-invasively measure blood flow across the cardiac valves.
The company raised AUD$16 million at $2.00 per share when it listed in 2003. At time of writing, its shares were up 5 per cent to $2.20.
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