SCOTTISH dental-imaging tech company Calcivis is getting its teeth into the US thanks to pre-market approval from the FDA.
CEO of the Edinburgh-based firm, Adam Christie, said the pre-approval process was delayed by Covid restrictions. “Our technology can help shift the paradigm in dental healthcare from ‘drill-and-fill’ restorative dentistry to a more preventive approach.”
Pre-market approval (PMA) is awarded only after a statutory process of scientific review to ensure efficacy and safety. The Calcivis Imaging System aims to move dentistry to a preventive treatment model. It allows dentists to watch tooth decay “live”, providing crucial insights as to whether a caries lesion is likely to progress and require treatment.
A photoprotein, in the presence of free calcium ions released from a decaying tooth surface, produces a short, low-level light flash. An integrated intra-oral sensor in the device detects the luminescence and presents clinicians with a “demineralisation map”.
Since it was founded in 2012, Calcivis has raised £16m in investments from sources including Archangels, the world’s longest-running angel-investment syndicate, and Scottish Enterprise, Scotland’s national economic development agency.