FDA Clears Fully Automated Cardiac Ultrasound Solution to Measure 2D and Doppler
Us2.ai, a Singapore-based medtech firm backed by Sequoia India and EDBI, has received U.S. Food and Drug Administration (FDA) clearance for Us2.v1, a completely automated decision support tool for echocardiography.
After multiple trials with global pharmaceutical partners, and a validation study at the Brigham & Women’s Hospital, Us2.ai announced the artificial intelligence (AI) software is now available for clinical use in the United States.
Us2.v1 is an automated clinical workflow solution that recognizes and analyzes 2-dimensional and Doppler echo images for comprehensive cardiac ultrasound measurements needed for the diagnosis, prediction and prognosis of heart disease.
“With this release, we’ve moved the field of AI beyond just a narrow feature for echocardiography, to a complete decision-support solution for cardiologists and primary care providers,” said James Hare, CEO and co-founder of Us2.ai. “Us2.v1 eliminates the manual workflows and lack of transparency from semi-automated, single measurement, black box AI approaches, creating a complete and fully automated patient report with editable annotations, conclusions and comparisons to international reference guidelines.”
Us2.v1 automated measurements include 2-D (cardiac volumes, all 4 chambers of the heart), M-mode (e.g. tricuspid annular plane systolic excursion), spectral Doppler (blood flow across all valves, both PW and CW measurements) and tissue Doppler; thus covering the vast majority of standard measurements for adult transthoracic echocardiography recommended by the American Society of Echocardiography (ASE), European Association of Cardiovascular Imaging, and British Society of Echocardiography.
Fully automated Us2.v1 measurements were shown to be completely interchangeable with expert human measurements. The AI measurements also were completely reproducible for a given patient study, with image processing/analysis algorithm computation time of approximately 2 minutes per study, the vendor said.
Us2.v1 is designed to help to accelerate the diagnosis of diseases such as pulmonary hypertension and heart failure (HF).
The company recently announced a partnership with EchoNous, maker of ultra-portable, AI-guided, point-of-care ultrasound (POCUS) tools. EchoNous is the maker of Kosmos, the only handheld ultra-mobile tool offering diagnostic grade imaging with Continuous-Wave (CW) Doppler capability.
Us2.v1 also automates the detection of pulmonary hypertension according to the European Society of Cardiology (ESC) / European Respiratory Society (ERS) guideline definition for echocardiographic detection of pulmonary hypertension. Pulmonary hypertension remains under-detected, leading to treatment delays and poor outcomes.
Similarly, heart failure is a commonly missed diagnosis, particularly in general practices where access to echocardiography is currently limited.
“AstraZeneca is excited to partner with Us2.ai because we believe it has the potential to transform the management of heart failure, bringing early access to echocardiography, including expert-level analyses, to primary care settings, the general community and even to patients’ home. Together, we look forward to helping improve care for patients with heart failure and keeping them out of hospital”, said Joris Silon, senior vice president, CVRM, bioPharmaceuticals business unit, AstraZeneca.
