Ensight-AI, a Yale start-up and leader in AI-based cardiovascular diagnostics, announces the receipt of the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation for their ECGvision-TTR© Technology for early detection of ATTR-Cardiomyopathy.  

Ensight-AI is leveraging the newly launched U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program, which provides patients with timely access to innovative medical devices.

ATTR-CM (ATTR Amyloid Cardiomyopathy) is a life-threatening condition which is often under-diagnosed due to nonspecific symptoms, and disproportionately affects Black individuals, highlighting the urgency for innovative diagnostic solutions like ECGvision-TTR. By bridging diagnostic disparities and improving access to care, ECGvision-TTR represents a pivotal advancement in healthcare equity.

The potential implications of ECGvision-TTR are profound, said Rohan Khera, MD, MS, Assistant Professor, Cardiovascular Medicine, Yale School of Medicine; an academic co-founder of Ensight-AI, Inc. By facilitating early diagnosis, the technology has the potential to revolutionize patient care and significantly reduce healthcare costs.

Moreover, ECGvision-TTR paves the way for personalized care plans, enhancing the quality of life for individuals at risk of or suffering from ATTR-CM. I am immensely grateful for the opportunity the BDD program may provide us.”

ECGvision-TTR was developed through state-of-the-art deep learning algorithms and offers the unique ability to analyze 12-lead ECG images to detect signatures of ATTR Cardiomyopathy. This groundbreaking tool may empower clinicians with the ability to detect ATTR-CM at an early stage, enabling timely and effective interventions, ultimately leading to improved patient outcomes. The technology was developed in the Cardiovascular Data Science (CarDS) Lab by Dr. Rohan Khera, with Veer Sangha, a Yale graduate and Rhodes Scholar.

Ensight-AI was cofounded by Khera, Sangha, and Dr. Harlan Krumholz, the Harold H. Hines Professor of Medicine at Yale School of Medicine and a cardiologist.  

“ECGvision-TTR is a testament to Ensight-AI's commitment to leveraging cutting-edge technology to address unmet medical needs and improve patient care,” continued Khera.

About Ensight-AI 
The science behind Ensight-AI was developed at Yale’s Cardiovascular Data Science (CarDS) Lab, and has won several awards and grants, including a grant from the Blavatnik Family Foundation, which directly funded Ensight-AI regulatory consultations to-date.  Additional awards from American Heart Association, Doris Duke Charitable Foundation, Bristol Myers Squibb, and the Wilson Prize at Yale have been received.