Sensydia, a cardiac diagnostic company, has been awarded a $3 million Fast-Track Small Business grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to advance its AI-based Cardiac Performance System (CPS). The funding will support the development and clinical testing of machine learning algorithms designed to enable earlier detection and therapy guidance for patients with heart failure and pulmonary hypertension.
AI-Driven Cardiac Assessment
The Cardiac Performance System (CPS) aims to revolutionize heart failure therapy by expanding access to cardiac performance assessment outside the hospital setting. The CPS platform delivers accurate, non-invasive assessment of cardiac performance, including cardiac output, ejection fraction, and pulmonary pressures, in under 5 minutes. This is achieved through proprietary waveform machine learning methods trained against gold-standard measurements from in-hospital catheterization lab data.
Clinical and Economic Impact
Currently, the U.S. spends over $30 billion annually on heart failure diagnosis and management, often relying on costly and risky in-hospital catheterization procedures for accurate cardiac performance assessment. Sensydia's CPS platform offers a non-invasive alternative, potentially reducing healthcare costs and improving patient outcomes.
Prior FDA Clearances and Designations
Sensydia received FDA 510(k) clearance in 2018 for non-invasive measurement of ejection fraction using first-generation hardware. In 2022, the CPS was granted Breakthrough Device Designation by the FDA to measure cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure.
Future Directions
"We are honored to be a recipient of this competitive award from the NIH/NHLBI and look forward to unlocking the capabilities of AI-based cardiac assessment to provide personalized care to patients suffering from heart disease," said Aman Mahajan, MD, Sensydia Chief Medical Officer. Phase I of the grant is budgeted for approximately $600,000, with Phase II receiving $2.4 million upon successful completion of Phase I milestones. This NIH award marks a significant milestone for Sensydia, a company committed to developing AI-based solutions for the diagnosis and management of cardiopulmonary diseases.
