CAlCiVis receive Premarket Approval by FDA
We are delighted to see our customer, Calcivis (Edinburgh, UK) receive Approvable Letter from the US Food and Drug Administration (FDA), for their Premarket Approval (PMA) of the CALCiViS® Imaging System. Calcivis have two stopped-flow instruments which are used to characterise the transient luminescence of their patented photoprotein which is key to their system which dentists use to detect early signs of decay in tooth enamel. Readers should look at their website which is rich in information and makes an interesting read. Chief Technical Officer Bruce Vernon said: “Calcivis has developed a completely novel imaging technology that enables clinicians to visualise active decay early, when it can be stopped and potentially reversed, so that patients can be treated before a cavity develops that requires drilling and filling. The stopped-flow analyser is proving extremely useful for us. We currently have 2 units, one is being used within a GMP manufacturing facility for in-process and release testing. The second machine is with us in the Edinburgh R+D lab.” 