What You Should Know:

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

Latest AI ultrasound tool makes it even easier toautomatically assess ejection fraction, a key indicator of cardiac function, atthe bedsideincluding 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 FDA510(k) clearance for an updated version of Caption Interpretation, whichenables clinicians to obtain quick, easy and accurate measurements of cardiacejection fraction (EF) at the point of care.

Impact of Left Ventricular Ejection Fraction

Left ventricular ejection fraction is one of the most widelyused cardiac measurements and is a key measurement in the assessment of cardiacfunction across a spectrum of cardiovascular conditions. Cardiovasculardiseases kill nearly 700,000 Americans annually, according to the Centers forDisease Control and Prevention; furthermore, considering EF as a new vital signmay shed light on determining cardiac involvement in the progression of COVID-19. Arecent global surveypublished inEuropean Heart Journal Cardiovascular Imagingreportedthat cardiac abnormalities were observed in half of all COVID-19 patientsundergoing ultrasound of the heart, and clinicalmanagement was changed inone-third of patients based on imaging.

How Caption Interpretation Works

Caption Interpretation applies end-to-end deep learning toautomatically select the best clips from ultrasound exams, perform qualityassurance and produce an accurate EF measurement. The technology incorporatesthree ultrasound views into its fully automated ejection fraction calculation:apical 4-chamber (AP4), apical 2-chamber (AP2) and the readily-obtainedparasternal long-axis (PLAX) viewan industry first. While ejection fraction iscommonly measured using the more challenging apical views, the PLAX view is ofteneasier to acquire at the point of care in situations where patients may not beable to turn on their sides, such as intensive care units, anesthesiapreoperative settings and emergency rooms. This software provides unprecedentedaccess for healthcare providers to bring specialized ultrasound techniques tothe bedside.

Developing artificial intelligence that mimics an expert physicians eye with comparable accuracy to automatically calculate EFincluding from the PLAX view, which has never been done beforeis a major breakthrough, saidRoberto M. Lang, MD, FASE, FACC, FESC, FAHA, FRCP, Professor of Medicine and Radiology andDirector of Noninvasive Cardiac Imaging Laboratories at theUniversity of ChicagoMedicine 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 EFis frequently performed in lieu of a quantitative measurement due to resourceand time constraints. Using Caption Interpretation in these settings providesthe best of both worlds: it is as easy as performing a visual assessment, butwith comparable performance to an expert quantitative measurement.

Caption Interpretation was trained on millions of imageframes to correctly estimate ejection fraction, emulating the way an expertcardiologist learns by evaluating EF as part of their clinical practice. Whilevirtually all commercially available EF measurement software works by tracingendocardial borders, Caption Interpretation analyzes every pixel and frame in agiven clip to produce highly accurate EF measurements.

Caption Health broke new ground in 2018 when it received thefirst FDA clearance for a fully automated EF assessment software. Two yearslater, Caption Interpretation remains the only fully automated EF toolavailable to providers, and, with todays clearance, continues to be the pacesetterin ultrasound interpretation.

We are pleased to have received FDA clearance for our latest AI imaging advancementour third so far this year, said Randolph P. Martin, MD, FACC, FASE, FESC, Chief Medical Officer of Caption Health, Emeritus Professor of Cardiology atEmory 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 CaptionGuidance,cleared by the FDA earlier this year,as part of the Caption AI platform. Caption Guidanceemulates the expertise of a sonographer by providing over 90 types of real-timeinstructions and feedback. These visual prompts direct users to make specifictransducer movements to optimize and capture a diagnostic-quality image. Incontrast, use of other ultrasound systems requires years of expertise torecognize anatomical structures and make fine movements, limiting access toclinicians with specialized training.

The company recently closedits Series B funding round with$53 millionto further develop andcommercialize this revolutionary ultrasound technology that expands patientaccess to high-quality and essential care.

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