BLOOM43 - BLOOM43 is a wearable medical device consisting of a preconditioning unit connected to a battery via a cable. The preconditioning unit integrates a user interface and a temperature-controlled heating element. Designed for preoperative use, BLOOM43 delivers supraphysiological preconditioning to the skin through the application of topical heat, which temporarily improves blood flow circulation. The battery can be securely attached to clothing or carried in a pocket for convenience. The preconditioning unit is intended to be placed within a bra, positioned against the breast skin (ideally centered over the nipple-areola complex), and worn for approximately 3 hours. It operates in a series of 30-minute active heating cycles within the range of 40°C (104°F) to 45.5°C (113.9°F), with an approximate skin temperature of 40°C (104°F) to 44°C (111.2°F), alternating with nonactive heating periods.
2025-10-13