Visiomed gains US FDA clearance for improved Funhaler09:24,...

Visiomed gains US FDA clearance for improved Funhaler
09:24, Friday, November 30, 2007

Sydney - Friday - November 30: (RWE Australian Business News) -
Visiomed Group Ltd (ASX:VSG) has secured FDA clearance for the 510(k)
submission of its redesigned and improved proprietary Funhaler
paediatric asthma incentive spacer.
FDA notification of pre-market clearance allows Visiomed to
market and sell the improved Funhaler into the US, the world's biggest
market for medical devices.
Improvements to the Funhaler design evaluated by the FDA
included a redesigned incentive module, a redesigned and patent-pending
low-flow valve controlling delivery of medication and a number of
improved manufacturing processes.
Chief executive Dr William Dolphin said, "The recently
introduced design changes to the Funhaler significantly improve
performance and the FDA determined that the implemented changes modify
the existing device sufficiently to warrant 510(k) submission."
Dr Dolphin noted FDA clearance of the improved device was
"extremely rapid".
"We received notification of 510(k) clearance from the FDA less
than 60 days following submission.
"We're very pleased with the rapid and positive response from
the FDA as 510(k) clearance is required for the Funhaler spacer product
to be sold into the US market."
The company recently appointed Alliance Tech Medical, a
pre-eminent distributor of respiratory products in the US healthcare
industry, as distribution partner for the US market.
"The US is the world's major market for medical products and is
a key market for Visiomed. 510(k) clearance gives us a green light to go
after this important market," said Dr Dolphin.
"With a population of over 300m there are an estimated 42m
asthmatics in the US, of which approximately 10m are under the age of
nine."