Evidence & regulatory

Building evidence the right way

We are a pre-market medical technology company conducting a rigorous IRB-supervised clinical study. We say only what the evidence supports.

Clinical study

IRB-approved trial

Our clinical study is approved by the University of Minnesota Institutional Review Board. The study is designed to generate peer-reviewable evidence on the accuracy, clinical utility, and safety of Ella's core detection capabilities.

Study protocol, consent procedures, and data handling practices all meet the standards required for submission to a peer-reviewed journal and for future FDA engagement.

IRB Sponsor

University of Minnesota

Study phase

Pilot — pre-pivotal

Primary endpoint

Fall detection sensitivity & specificity

Setting

Memory care, long-term care facility

Regulatory

Regulatory posture

We are honest about where we are in the regulatory lifecycle. Ella 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.

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.

Partnerships

Research partnerships

University of Minnesota

Clinical study design, IRB oversight, and academic collaboration on signal processing and clinical validation methodology.

Gener8tor

Accelerator alumni. Gener8tor's network has supported our early commercial development and investor relationships.

Questions about our regulatory approach?