Ensight-AI, a cutting-edge AI-based cardiovascular diagnostics company, has recently been honoured with the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for their ECGVision-TTRTechnology. This advanced technology is specifically developed to identify early indicators of ATTR-Cardiomyopathy, a serious and often overlooked condition.
The FDA’s Breakthrough Devices Program aims to provide patients with timely access to innovative medical devices, making this designation a significant milestone for Ensight-AI. ATTR-CM, also known as ATTR Amyloid Cardiomyopathy, poses a significant threat to individuals, particularly those in the Black community, due to its nonspecific symptoms. This highlights the urgent need for advanced and equitable diagnostic solutions like ECGVision-TTR, which has the potential to address diagnostic disparities and improve access to care.
Developed through the use of state-of-the-art deep learning algorithms, ECGVision-TTR has the unique capability to analyse 12-lead ECG images to identify signatures of ATTR Cardiomyopathy. This revolutionary technology has the capacity to enable healthcare professionals to detect these indicators at an early stage, thereby facilitating prompt and effective interventions that can ultimately lead to improved patient outcomes.
The development of ECGVision-TTR was led by Dr. Rohan Khera and Veer Sangha, a Yale graduate and Rhodes Scholar, in collaboration with the Cardiovascular Data Science (CarDS) Lab. Additionally, Ensight-AI was co-founded by Dr. Khera, Sangha, and Dr. Harlan Krumholz, a distinguished cardiologist and Harold H. Hines Professor of Medicine at the Yale School of Medicine.
Dr. Khera expressed his gratitude for the FDA’s recognition of ECGVision-TTR, emphasizing the company’s dedication to utilizing cutting-edge technology to address unmet medical needs and enhance patient care. This achievement represents a significant step towards personalized care plans and improved quality of life for individuals at risk of or suffering from ATTR-CM.
For further details about this revolutionary technology, please visit www.yale.edu.
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