Mirabelle develops the first at‑home breast screening device that converts a subjective breast exam into a consistent, reproducible monthly screen, allowing women to monitor breast health between biennial mammograms.
Funding
Funding not disclosed
Founders
Product
Problem
Women are advised to obtain a mammogram every two years, leaving a 23‑month interval with no reliable method for self‑screening. This gap can allow aggressive breast cancers to grow undetected, reducing survival chances.
Solution
Mirabelle offers an at‑home breast screening device that standardizes the subjective breast exam into a consistent, reproducible monthly test. The hardware captures tactile and visual data, which is automatically analyzed and stored in a companion mobile app. The app tracks longitudinal changes, flags deviations that may require clinical evaluation, and provides users with clear guidance on next steps. By delivering a regular, objective screening between biennial mammograms, the system aims to close the detection gap and enable earlier intervention. The device is currently in pre‑FDA clearance, with patents filed and a clinical trial slated for June 2026.
Target Audience
Primary users are women aged 30 and above who follow a biennial mammography schedule and seek a reliable method to monitor breast health at home between clinical visits.
Features
- Handheld medical device that quantifies breast tissue characteristics through calibrated sensors for a repeatable monthly exam
- Integrated mobile application that logs results, visualizes trends over time, and generates alerts for potential abnormalities
- Proprietary algorithms that convert raw sensor data into standardized screening metrics, reducing operator variability
- Secure cloud storage compliant with health‑data regulations, enabling remote review by clinicians if needed
- Validated by experts at Yale, Harvard, Dartmouth, and UCONN, with an international patent pending
- Designed for easy home use without specialized training, supporting regular self‑screening between clinical mammograms