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.
