- Optiscan Imaging (OIL) submits a Food and Drug Administration (FDA) Pre-Market Notification (510(k)) application for the InVivage device
- InVisage is a non-invasive, instantaneous form of oral imaging that targets severe health consequences of the late-stage diagnosis of oral cancers and precancerous lesions
- CEO and Managing Director Professor Camile Farah says the submission is a key step towards strengthening the commercialisation of the device
- OIL shares were up 4.17 per cent on the market to end the day at 12.5 cents each
Optiscan Imaging (OIL) has submitted a Food and Drug Administration (FDA) Pre-Market Notification (510(k)) application for the InVivage device.
“The board is delighted by this 510(k) submission to the FDA, and looks forward to its clearance in due course,” Chairman Robert Cooke said.
“The company will pursue appropriate regulatory approval processes for other markets and will provide further updates on this at a later point in time.”
InVisage is a non-invasive, instantaneous form of oral imaging that targets severe health consequences of the late-stage diagnosis of oral cancers and precancerous lesions.
It enables real-time, 3D in-vivo imaging at the sub-cellular to provide surgeons, physicians and pathologists with high-resolution microscopic images that are used to assist with the diagnosis and treatment of oral pathologies.
“I’m delighted to announce the submission of our 510(k) application for InVivage, a truly landmark achievement for the company,” CEO and Managing Director Professor Camile Farah commented.
“This is a key step towards strengthening the commercialisation of the InVivage device and bringing our revolutionary imaging and realtime pathology technology to the world.
Shares in Optiscan were up 4.17 per cent on the market and ended the day at 12.5 cents at market close.