Etiometry, Inc. - FDA 510(k) Cleared Devices

Etiometry, Inc. is a clinical decision-support software company founded in 2010. Based in Boston, the company develops AI-driven clinical intelligence platforms for intensive care settings. The platform aggregates patient data, provides risk analytics, automates clinical pathways, and supports quality improvement initiatives in high-acuity care environments.

Etiometry has received 11 FDA 510(k) clearances from 11 total submissions since 2015. The company specializes exclusively in Cardiovascular devices and software solutions. The latest clearance in 2026 demonstrates continued regulatory activity and product innovation in critical care technology.

The Etiometry Platform supports clinical workflows including extubation readiness assessment, vasoactive medication weaning, goal-directed therapy, and acute kidney injury screening. The platform is deployed across academic medical centers and leading children's hospitals. Published observational studies associate platform use with reduced length of stay, decreased ICU readmissions, and shorter mechanical ventilation duration.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.