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Inditherm plc has been granted 510(k) clearance by the US Food and Drug
Administration ("FDA") to sell its CosyTherm neonatal warming systems in the
USA. This follows a similar clearance for the Company's patient warming products
granted in May 2006.
FDA
clearance opens the way for Inditherm to market its innovative neonatal products
in the US market. The CosyTherm system is ideally suited for use in Special Care
Baby Units (SCBU), Neonatal Intensive Care Units (NICU), post-natal wards and
delivery suites. It can also be adapted for use in transport applications.
Commenting
on the news, Nick Bettles, Medical Division Director at Inditherm, said, "We are
delighted that we can now market our full range of medical products into the
USA. Given the importance of FDA clearance, not just in terms of US legislation,
but also as reassurance to potential purchasers worldwide, this further
underpins the growth plans for our medical business."
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