Coredio has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Cardiac Performance Simulation Engine, a software-based platform developed to support heart failure assessment.
The company has also been accepted into the FDA’s Total Product Life Cycle Advisory Program, helping accelerate its path towards regulatory review.
The CPSE™ platform is designed to estimate key haemodynamic measurements using data collected from consumer smart watches and standard blood pressure monitors.
Intended for use under physician supervision, the technology aims to provide valuable insights into a patient’s heart function both in healthcare settings and at home.
Heart failure affects millions of people and remains a leading cause of hospital admissions, particularly among older adults. Monitoring patients after discharge can be challenging, as detailed cardiac assessments are often limited outside clinical environments.
Coredio’s platform seeks to address this issue by offering a non-invasive method to evaluate important indicators such as left ventricular end-diastolic pressure, central venous pressure, systemic vascular resistance and cardiac index.
The system combines artificial intelligence with a digital model of the cardiovascular system to analyse patient data and assess heart function.
By enabling more frequent monitoring, the technology could help clinicians identify changes in a patient’s condition earlier and support more timely treatment decisions.
