COMPUMEDICS SLEEP MONITOR APPROVED FOR CANADIAN USE
Compumedics Ltd has received regulatory approval to market its portable Somté sleep-cardiology recording system in Canada.
Australian medical technology company Compumedics Ltd (ASX:CMP) has received regulatory approval to market its portable Somté sleep-cardiology recording system in Canada.
Health Canada has issued a Medical Device Licence to enable Somté to be used in the fast growing Canadian sleep disorder market. This follows last year’s European Union, Australian and Japanese regulatory approvals. Approval to market Somté in the US$131.9million United States sleep diagnostic market is currently under consideration by the FDA.
Somté is a first of its kind, lightweight medical recorder that combines features of diagnostic sleep systems and cardiac recorders. The combination of the technologies addresses the mounting evidence of the correlation between sleep disordered breathing and cardiovascular disease. As many as 40% of the estimated 58 million Americans suffering some form of cardiovascular disease also have a sleep disorder. As the 200 gram Somté is extremely portable, the patient study can be done at home, giving a more natural setting to measure sleeping habits and eliminating the expense of hospitalisation.
Compumedics executive chairman, David Burton said, “The Canadian approval is further confirmation of the international acceptance of Somté technology. We now keenly await the US FDA decision, which if it is positive, will give us access to every major sleep disorder market in the world.”
The Canadian sleep disorder industry is still in its relative infancy with the market estimated to be around US$5 million per annum, but recent government initiatives in the area indicate that annual growth similar to the 15% experienced in other markets will be achieved.
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Compumedics Limited, founded in 1987, is a global leader in the design and manufacture of diagnostic technology for sleep disorders, neurophysiology and cardiology. Compumedics was listed on the Australian Stock Exchange in December 2000. The company has corporate headquarters in Melbourne, Australia and offices in the United States, Asia and Europe. Compumedics holds 70% of the Australian sleep diagnostic market in Australia and is fast becoming a major presence in the US marketplace for both its sleep diagnostic as well as its neuro-diagnostic products.