The CALCIVIS imaging device is a specialised device designed exclusively to image the tooth after delivering an application of CALCIVIS photoprotein. The handheld medical device is initiated via a ‘one-touch’ computer-controlled process. A specialised sensor integrated into the device immediately detects the resulting luminescence (light flash), and in less than one second, bespoke software presents a chairside demineralisation ‘hotspot’ image map to clinicians, enabling informed and efficient dialogue with patients.
Our Approach
After designing and manufacturing a number of advanced prototypes of the device for clinical trials, Wideblue then worked with CALCIVIS to develop a full commercial product.
Wideblue were responsible for the:
- Optical and imaging design of a highly sensitive visible light and luminescent imaging system
- Mechanical and electrical design of the CALCIVIS photoprotein fluid delivery sub-system
- Electronics design and manufacture of the custom ultra-low light complementary metal-oxide-semiconductor (CMOS) camera printed circuit board (PCB)
- Firmware development
- Industrial design of ergonomic housing
Solution
The design for the commercial product was transferred to manufacturing and the device has been submitted to the US Food and Drug Administration (FDA) for premarket approval (PMA) for release in the US market.