LONDON (Thomson Financial) - BBI Holdings PLC said FDA clearance to market
the SensoCard Plus glucose meter in the US has been delayed, due to issues
raised by the regulator.
The company said the issues will require further investigation, and possible
additional collation of patient data.
The AIM-listed developer and manufacturer of rapid-result diagnostic tests
and reagents said it does not expect revenues in US from SensoCard Plus in
2008-09 due to this uncertainty.
BBI Holdings said the FDA's requirements on SensoCard Plus are beyond its
control, and that it will involve investment by the manufacturer, 77
Elektronika.
The SensoCard Plus talking blood glucose meter enables visually impaired and
blind diabetes patients to monitor their blood glucose levels at home.
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