Ultromics

Ultromics is a health technology company specializing in the development of artificial intelligence (AI) solutions for cardiovascular disease detection and management.

Ultromics' flagship product, EchoGo Heart Failure, received FDA clearance in December 2022. This breakthrough AI platform can detect Heart Failure with Preserved Ejection Fraction (HFpEF) from a single echocardiogram image, a condition that accounts for 50% of heart failure cases worldwide. By automating the detection process, EchoGo Heart Failure aims to improve the accuracy of HFpEF diagnosis, enabling earlier treatment and reducing the significant burden on patients and healthcare systems.

In July 2023, the Centers for Medicare and Medicaid Services (CMS) established a new HCPCS code (C9786) for EchoGo Heart Failure, facilitating its adoption in hospital outpatient settings for Medicare beneficiaries. Additionally, in August 2023, CMS approved a New Technology Add-On Payment (NTAP) for the device, providing incremental reimbursement for its use in acute hospital inpatient stays from October 2023. Ultromics has also developed EchoGo Amyloidosis, an AI platform for detecting cardiac amyloidosis, a debilitating disease caused by abnormal protein accumulation in the heart.

In April 2023, EchoGo Amyloidosis received FDA Breakthrough Device Designation, recognizing its potential to provide improved diagnosis and treatment for this underdiagnosed condition. The company is currently preparing regulatory submissions for the US market, with anticipated commercialization in early 2024.

Key customers and partnerships In January 2024, Ultromics announced a partnership with Pfizer to support the validation and FDA clearance of EchoGo Amyloidosis, further advancing the development of this innovative technology.