PRESS RELEASE
October 9, 2024 – Carelog, a startup at the forefront of cardiac diagnostics, today announced that its proprietary ECG-based algorithm, Diastolytix, has received the prestigious FDA Breakthrough Device Designation. The software aims to transform how healthcare professionals detect diastolic dysfunction, an often silent precursor to heart failure with preserved ejection fraction (HFpEF).
HFpEF is a condition associated with substantial morbidity and mortality, affecting millions globally. Unfortunately, the condition is frequently underdiagnosed due to its subtle clinical presentation and the complex, costly nature of traditional diagnostic methods such as echocardiography. Carelog’s AI-powered ECG solution offers a cost-effective, non-invasive alternative to this diagnostic process, helping clinicians detect diastolic dysfunction earlier, when interventions are most beneficial.
“I’m thrilled to announce that Carelog has received FDA Breakthrough Device Designation for our innovative ECG algorithm that detects diastolic dysfunction—an often underdiagnosed precursor to HFpEF,” said Aman, Founder and CEO of Carelog. “Early detection is critical, as HFpEF patients face significant challenges: current treatment options are limited, mostly pharmaceutical, and the 5-year survival rate for these patients can range from 40% to 60%.”
Carelog’s proprietary algorithm, Diastolytix, leverages machine learning to analyze ECG data and identify Grade 3 diastolic dysfunction. The FDA’s Breakthrough Device Designation recognizes the device’s potential to provide more effective diagnosis and treatment options for life-threatening conditions.
“We are excited to receive this recognition from the FDA, which underscores the significance of our technology in addressing the gaps in HFpEF diagnosis and management,” continued Aman. “Our goal is to provide an interface that can act as a reliable and accessible screening tool to complex (and often costly) screening procedures like Echocardiography and invasive tests.”
The FDA Breakthrough Device Designation is awarded to medical devices and products that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation enables Carelog to collaborate closely with the FDA, expediting the development and review of Diastolytix to bring this technology to patients sooner.
About Carelog
Carelog is at the forefront of AI-driven cardiac diagnostics, dedicated to developing transformative solutions for cardiovascular health. By leveraging cutting-edge machine learning and data analytics, Carelog’s technologies enable healthcare professionals to make more informed decisions, enhancing patient outcomes and improving quality of life. For more information, visit www.carelog.ai.