Optiscan wins FDA clearance for endomicrosope

Optiscan (ASX:OIL) has won earlier-than-expected clearance from the US Food and Drug Administration (FDA) for the flexible endomicroscope it is jointly developing with Pentax.

With regulatory approval from the FDA's centre for devices and radiological health in place, Optiscan expects its Japanese marketing partner Pentax to begin to roll out the marketing process in both the US and the EU, where CE Mark approval was granted in mid-October. Marketing will include the distribution of product marketing materials and product specification information, as well as arrangements for commissioning of instruments and training programs for operators.

"Class II regulatory clearance is an important commercial step in the evolution of our products because it allows their use to image cell structures inside the body," said Optiscan CEO Matthew Barnett.

The news received a tepid response from the market -- Optiscan's shares slipped slightly slower today, hovering around AUD$0.40 at time of writing.