Alio Advances FDA Clearance with New CAVA Study to Broaden Platform's Patient Use
13 September 2024
Alio, Inc., a leader in AI-powered clinical-grade wearables, has announced an international study aimed at extending its technology beyond the dialysis field. The CAVA protocol will evaluate Alio’s FDA-cleared SmartPatch technology for broader applications in chronic condition management.
The study will involve up to 300 participants and focus on assessing the SmartPatch’s ability to non-invasively monitor key health metrics from the calf, including hemoglobin, hematocrit, potassium levels, SpO2, blood volume, and heart rate.
Preliminary results have shown a strong correlation between calf-based data and Alio's previous FDA validation studies, as well as with traditional measurement methods.
This development will enable the use of Alio's technology for patients without vascular access sites.
The CAVA study builds on earlier research demonstrating the accuracy and reliability of Alio’s technology for arm-based vascular access.
These findings supported Alio’s FDA clearances for skin temperature, auscultation sound data, and heart rate in 2022, and for hematocrit, hemoglobin, and potassium in 2023, establishing Alio as a pioneer in non-invasive potassium monitoring.
With additional metrics such as blood pressure and electrolytes nearing FDA validation, Alio’s technology aims to enhance chronic disease management by enabling earlier interventions and potentially improving patient outcomes.
Source: businesswire.com