Gates Foundation Awards Caption Health $4.95M Grant to Develop AI-Guided Lung Ultrasound System

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know:

– Bill & Melinda Gates Foundation awards Caption
Health a $4.5M grant to support the development of an AI-guided lung ultrasound

– The grant from the Bill & Melinda Gates Foundation
will be leveraged to create new AI technology that allows medical professionals
without prior ultrasound experience to perform lung ultrasounds, expanding
access to quality medical care.

Caption Health, a leading medical
artificial intelligence (AI)
company, today announced that it has received
a grant from the Bill & Melinda
Gates Foundation
in the amount of $4.95 million to support the development
of innovative AI technology for lung ultrasound. The grant was awarded to
Caption Health by the foundation due to the need to further develop solutions
that enable timely and accurate diagnosis of pneumonia, the leading killer of
children under 5, in resource-limited settings with a shortage of highly
trained physicians. 

Caption Health already has the first and only FDA cleared AI
platform that enables medical professionals without prior ultrasound experience
to perform cardiac ultrasound exams (Caption
). Like cardiac ultrasound, performing lung ultrasound requires a high
level of clinical skill and specific expertise, which has limited its broad
adoption. With this grant, Caption Health will be able to expand its
first-in-class AI technology to lung ultrasound, providing healthcare workers with
real-time guidance to acquire diagnostic-quality images for each lung zone and
automated interpretation to detect key lung pathologies.

Why It Matters

“Ultrasound can be challenging for clinicians without prior experience because it requires skill in both obtaining and interpreting images. Caption Health is the leader in developing artificial intelligence that combines image acquisition and interpretation to enable clinicians to perform ultrasound regardless of skill level,” said emergency medicine physician Dr. Chris Moore, Associate Professor of Emergency Medicine, Chief of the Section of Emergency Ultrasound, and Director of the Emergency Ultrasound Fellowship at Yale. “Expanding this AI to lung ultrasound and putting it in the hands of clinicians could have profound implications for the diagnosis and treatment of pneumonia, a leading cause of death in our youngest global citizens, as well as for COVID-19 and other lung conditions.”

Lung ultrasound enables the detection of a range of
pulmonary pathologies such as pneumonia and other consolidations, pulmonary
edema, pleural effusions and pneumothorax. Furthermore, it is non-invasive,
portable and does not expose recipients to harmful radiation. As the cost of
miniaturizing ultrasound hardware decreases, Caption Health’s AI technology
solves the remaining challenge currently limiting ultrasound’s widespread use:
enabling clinicians without lengthy specialized training to acquire and interpret
diagnostic-quality ultrasound images. 

As COVID-19 cases rise, lung ultrasound is playing a
critical role in the triage and monitoring of these patients. When patients
arrive in the Emergency Department with suspicion of COVID-19, lung ultrasound
can be used for early detection of pulmonary involvement, offering higher sensitivity than chest x-rays. For those who are
diagnosed with COVID-19, lung ultrasound can be used to grade the degree of
pulmonary involvement, and to monitor changes over time. Caption Health’s AI
technology will expand access to this powerful diagnostic tool by enabling
medical professionals without prior experience in lung ultrasound to perform
these exams, and could eventually lead to lung ultrasound becoming a routine
part of point-of-care assessments.

 “Pulmonary health and cardiovascular health are closely intertwined,” said cardiologist Dr. Randolph Martin, FACC, FASE, FESC, Chief Medical Officer of Caption Health. “Abnormalities or disease states in the lungs can directly cause prominent abnormalities of cardiac function, just as disease states in the heart can lead to marked abnormalities in the lungs. By taking our unique methodology for developing breakthrough AI for cardiac imaging and applying it to lungs, we will continue to broaden the impact we can have in helping with the management of patients with conditions affecting these two vital systems.”

Future Research Plans

Having demonstrated extensive clinical validation for its
cardiac ultrasound technology, including a multi-center prospective clinical
study and numerous published abstracts, Caption Health intends to seek similar
validation for its AI lung ultrasound technology to demonstrate the ability of
the technology to equip non-specialists to perform lung ultrasound exams.

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

What You Should Know:

– Northwestern Memorial Hospital is the first in the
nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including
measurement of ejection fraction – the most widely used measurement to assess
cardiac function.

– Caption Health’s AI-guided cardiac ultrasound enables clinicians – including those without experience – to accurately perform diagnostic-quality exams — accelerating the availability of information and saving lives.

– Caption AI has been shown to produce assessments
similar to those of experienced sonographers in work presented to the American
Society of Anesthesiologists.

Northwestern Memorial
is the first hospital in the United States to purchase Caption Health’s
intelligence (AI)
technology for ultrasound, Caption AI. The FDA cleared, AI-guided
ultrasound system enables healthcare providers to acquire and interpret quality
ultrasound images of the human heart, increasing access to timely and accurate
cardiac assessments at the point of care.

Performing an ultrasound exam is a complex skill that takes years to master. Caption AI enables clinicians—including those without prior ultrasound experience—to quickly and accurately perform diagnostic-quality ultrasound exams by providing expert turn-by-turn guidance, automated quality assessment, and intelligent interpretation capabilities. The systems are currently in the hospital’s emergency department, medical intensive care unit, cardio-oncology clinic, and in use by the hospital medicine group.

Democratize the Echocardiogram

Point-of-care ultrasound (POCUS) has a number of benefits. Increased usage of POCUS contributes to more timely and accurate diagnoses, more accurate monitoring, and has been shown to lead to changes in patient management in 47% of cases for critically ill patients. POCUS also allows patients to avoid additional visits to receive imaging, as well as providing real-time results that can be recorded into a patient’s electronic medical record.

“Through our partnership with Caption Health, we are looking to democratize the echocardiogram, a stalwart tool in the diagnosis and treatment of heart disease,” said Patrick McCarthy, MD, chief of cardiac surgery and executive director of the Northwestern Medicine Bluhm Cardiovascular Institute, a group involved in the early development of the technology. “Our ultimate goal is to improve cardiovascular health wherever we need to, and Caption AI is increasing access throughout the hospital to quality diagnostic images.” 

How Caption Health Works

Caption AI emulates the expertise of a sonographer by providing real-time guidance on how to position and manipulate the transducer, or ultrasound wand, on a patient’s body. The software shows clinicians in real-time how close they are to acquiring a quality ultrasound image, and automatically records the image when it reaches the diagnostic-quality threshold. Caption AI also automatically calculates ejection fraction, or the percentage of blood leaving the heart when it contracts, which is the most widely used measurement to assess cardiac function.

Northwestern Medicine has been a tremendous partner in helping us develop and validate Caption AI. We are thrilled that they are bringing Caption AI into key clinical settings as our first customer,” said Charles Cadieu, chief executive officer and co-founder of Caption Health. “The clinical, economic and operational advantages of using AI-guided ultrasound are clear. Most important, this solution increases access to a safe and effective diagnostic tool that can be life-saving for patients.”

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know:

– Caption Health AI is awarded FDA 510(k) clearance for
its innovative point-of-care ejection fraction evaluation.

– Latest AI ultrasound tool makes it even easier to
automatically assess ejection fraction, a key indicator of cardiac function, at
the bedside–including on the front lines of the COVID-19 pandemic.

Caption Health, a Brisbane,
CA-based leader in medical AI technology, today announced it has received FDA
510(k) clearance for an updated version of Caption Interpretation™, which
enables clinicians to obtain quick, easy and accurate measurements of cardiac
ejection fraction (EF) at the point of care.

Impact of Left Ventricular Ejection Fraction

Left ventricular ejection fraction is one of the most widely
used cardiac measurements and is a key measurement in the assessment of cardiac
function across a spectrum of cardiovascular conditions. Cardiovascular
diseases kill nearly 700,000 Americans annually, according to the Centers for
Disease Control and Prevention; furthermore, considering EF as a new vital sign
may shed light on determining cardiac involvement in the progression of COVID-19. A
recent global survey published in European Heart Journal – Cardiovascular Imaging reported
that cardiac abnormalities were observed in half of all COVID-19 patients
undergoing ultrasound of the heart, and clinical management was changed in
one-third of patients based on imaging.

How Caption Interpretation Works

Caption Interpretation applies end-to-end deep learning to
automatically select the best clips from ultrasound exams, perform quality
assurance and produce an accurate EF measurement. The technology incorporates
three ultrasound views into its fully automated ejection fraction calculation:
apical 4-chamber (AP4), apical 2-chamber (AP2) and the readily-obtained
parasternal long-axis (PLAX) view—an industry first. While ejection fraction is
commonly measured using the more challenging apical views, the PLAX view is often
easier to acquire at the point of care in situations where patients may not be
able to turn on their sides, such as intensive care units, anesthesia
preoperative settings and emergency rooms. This software provides unprecedented
access for healthcare providers to bring specialized ultrasound techniques to
the bedside.

“Developing artificial intelligence that mimics an expert physician’s eye with comparable accuracy to automatically calculate EF—including from the PLAX view, which has never been done before—is a major breakthrough,” said Roberto M. Lang, MD, FASE, FACC, FESC, FAHA, FRCP, Professor of  Medicine and Radiology and Director of Noninvasive Cardiac Imaging Laboratories at the University of Chicago Medicine and past president of the American Society of Echocardiography. “Whether you are assessing cardiac function rapidly, or looking to monitor changes in EF in patients with heart failure, Caption Interpretation produces a very reliable assessment.”

Caption Interpretation Benefits

At the point of care, a less precise visual assessment of EF
is frequently performed in lieu of a quantitative measurement due to resource
and time constraints. Using Caption Interpretation in these settings provides
the best of both worlds: it is as easy as performing a visual assessment, but
with comparable performance to an expert quantitative measurement.

Caption Interpretation was trained on millions of image
frames to correctly estimate ejection fraction, emulating the way an expert
cardiologist learns by evaluating EF as part of their clinical practice. While
virtually all commercially available EF measurement software works by tracing
endocardial borders, Caption Interpretation analyzes every pixel and frame in a
given clip to produce highly accurate EF measurements.

Caption Health broke new ground in 2018 when it received the
first FDA clearance for a fully automated EF assessment software. Two years
later, Caption Interpretation remains the only fully automated EF tool
available to providers, and, with today’s clearance, continues to be the pacesetter
in ultrasound interpretation.

“We are pleased to have received FDA clearance for our latest AI imaging advancement—our third so far this year,” said Randolph P.  Martin, MD, FACC, FASE, FESC, Chief Medical Officer of Caption Health, Emeritus Professor of Cardiology at Emory University School of Medicine, and past president of the American Society of Echocardiography. “An accurate EF measurement is an indispensable tool in a cardiac functional assessment, and this update to Caption Interpretation makes it easier for time-constrained clinicians to incorporate it into their practice.”

Recent Traction/Milestones

Caption Interpretation works in tandem with Caption
Guidance, cleared by the FDA earlier this year, as part of the Caption AI platform. Caption Guidance
emulates the expertise of a sonographer by providing over 90 types of real-time
instructions and feedback. These visual prompts direct users to make specific
transducer movements to optimize and capture a diagnostic-quality image. In
contrast, use of other ultrasound systems requires years of expertise to
recognize anatomical structures and make fine movements, limiting access to
clinicians with specialized training.

The company recently closed
its Series B funding round with $53 million to further develop and
commercialize this revolutionary ultrasound technology that expands patient
access to high-quality and essential care.