Medical device company Calcivis is set to launch its new preventive bioluminescent dental imaging system in the US.
The move comes after the company secured final-stage US Food and Drug Administration (FDA) pre-market approval (PMA) for its new ergonomic, wireless, handheld imaging device, paving the way for commercialisation.
The system utilises a patented photoprotein that emits a brief, low-level light flash in the presence of free calcium ions from decaying tooth surfaces. An integrated intra-oral sensor detects this luminescence and provides dentists with a real-time demineralisation map at the chairside.
