Building evidence the right way
We are a pre-market medical technology company running a rigorous, IRB-supervised clinical study. We say only what the evidence supports.
Clinical study
An IRB-approved trial
Our clinical study is approved by the University of Minnesota Institutional Review Board. It is designed to generate peer-reviewable evidence on the accuracy, clinical utility, and safety of Ella AI's core detection capabilities.
Protocol, consent procedures, and data handling all meet the standards required for submission to a peer-reviewed journal and for future FDA engagement.
IRB sponsor
University of Minnesota
Pilot facility
Minneapolis memory-care community
Study phase
Pilot · pre-pivotal
Primary endpoint
Fall detection sensitivity & specificity
Deployment
36 units · 12 rooms × 3 care zones
The study, in context
A calm memory-care home, where the sensing runs quietly in the background of everyday life.
Regulatory
Honest about where we are
Ella AI is a Software as a Medical Device (SaMD). We are building toward FDA clearance through the De Novo or 510(k) pathway. We are not yet cleared, and we will not say otherwise.
SaMD classification
Software as a Medical Device under FDA guidance. We are designing to meet 21 CFR Part 820 quality system requirements from day one.
HIPAA
Our cloud infrastructure is built under an existing AWS Business Associate Agreement. All PHI handling follows HIPAA Security Rule requirements.
Cybersecurity
Device firmware, cloud infrastructure, and application code are developed and maintained in accordance with FDA cybersecurity guidance for medical devices.
Behind every endpoint is a person — and the science exists to keep them safe.
Partnerships
Research partnerships
University of Minnesota
Clinical study design, IRB oversight, and academic collaboration on signal processing and clinical validation methodology.
Pilot facility
A Minneapolis memory-care community hosts the first 36-unit deployment. Twelve memory-care rooms across three care zones provide the live clinical environment for the IRB-supervised study.
gener8tor
Accelerator alumni. The gener8tor network has supported our early commercial development and investor relationships.
