Calcivis targets US expansion after securing FDA PMA approval
Dental imaging technology company Calcivis is setting its sights on US growth having secured pre-market approval (PMA) from the US Food and Drug Administration (FDA). As the first Scottish medical device to secure the coveted accreditation, the Calcivis Imaging System aims to revolutionise the dental sector by enabling the move...
Scottish dental tech firm prepares to take on fight against tooth decay
As dentists worldwide begin to tackle the backlog of patients whose tooth decay may have worsened during the Covid-19 pandemic*, Edinburgh-based dental technology company, Calcivis, is preparing for a US launch with a restructuring of its board and the successful completion of its latest funding round. Calcivis has developed the world’s...
Publication of Calcivis Imaging System pivotal clinical study
Calcivis announces the publication of two key clinical and scientific papers in the journal, Clinical and Experimental Dental Research. Both are available via Open Access on the Wiley Online Library, using the links below. The pivotal clinical study was designed in consultation with the FDA, to support the FDA PMA...
CALCiViS receives Approvable Letter for its unique CALCiViS® Imaging System from US FDA
CALCiViS System, developed to enable and drive the adoption of preventive dentistry – enables real-time visualisation of active tooth decay Edinburgh, March 5th 2020 - CALCiViS, a medical devices company focused on modernising the management of tooth decay and enabling preventive dentistry, announces receipt of an Approvable Letter for...
CALCIVIS Completes £4.5 million Fund Raising
CALCIVIS® Completes £4.5 million Fund Raising Ahead of Anticipated PMA Approval of the CALCIVIS® Imaging System in the US Edinburgh, September 4th 2019 - CALCIVIS®, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has closed the final part of a...
CALCiViS raises £3.15 million to Fund PMA Approval of the CALCIVIS® Imaging System
Edinburgh, August 2nd 2018 - CALCiViS , a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has closed a £3.15 million equity funding round from existing investors Archangel Investors, Julz and the Scottish Investment Bank. The proceeds will be used to...
CALCiViS To Attend The IADR/PER General Session In London, England
Join us at the 96th General Session and Exhibition of the International Association of Dental Research IADR/PAN European Regional Congress ENABLING PREVENTIVE DENTISTRY – BIOTECHNOLOGY BASED IMAGING Thursday, 26 July 2018 11.30h to 13.00h This program will discuss modern cariology and the paradigm shift to minimally invasive and preventive dentistry...
CALCiViS soft launches its unique CALCIVIS imaging system in the United Kingdom
CALCiViS , a medical devices company focused on revolutionising the management of tooth decay, today announces the first soft launch of its unique CALCiViS imaging system in the United Kingdom (UK). The CALCiViS imaging system is a sophisticated medical device and consumable combination designed to transform the assessment and management...
CALCiViS announces FDA filing of the Pre-Market Approval (PMA) application for its unique CALCIVIS imaging system
Edinburgh, November 2017 – CALCiViS , a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces that the FDA has accepted its CALCiViS imaging system Pre-Market Approval (PMA) Application for substantive review. The filing of the PMA application to the FDA was made...