Calcivis

The Calcivis Imaging System has demonstrated safety and effectiveness in both adults and children aged six years or older. It enables real-time chairside visualization of active enamel demineralization using a bioluminescent photoprotein that reacts with free calcium ions. Multiple preclinical and clinical studies have been conducted, culminating in FDA premarket approval for commercialization in the US. The system allows early detection of caries activity, supporting preventive intervention before irreversible damage occurs. Initial commercial rollout began with a limited release in the Boston area in early 2024. The device also holds UKCA mark for use in the UK.

No therapeutic outcomes are claimed as it’s a diagnostic/preventive tool rather than a treatment.

Clinical results support its utility as an objective assessment tool to guide preventive dentistry decisions.

[Note—no published pivotal trial data found; summary based on regulatory approvals and company statements.]