FDA Expedites Clearance of Caption Health Ultrasound Software to Aid Frontline Healthcare Workers in Fight Against COVID-19 Pandemic

BRISBANE, Calif., May 12, 2020 /PRNewswire/ -- In response to the growing body of evidence demonstrating the impact of COVID-19 on the heart, the U.S. Food and Drug Administration (FDA) has expedited clearance of an update to software from Caption Health, a leading medical artificial intelligence (AI) company. The innovative technology makes it radically easier for frontline healthcare workers to perform diagnostic-quality cardiac ultrasounds. Following a review of just 25 days (faster than 99 percent of FDA clearances since 2015), the FDA cleared an updated version of Caption Guidance™, the first and only AI-guided medical imaging acquisition system.

Caption Guidance emulates the guidance of an expert sonographer by providing over 90 types of real-time instructions and feedback. These visual prompts help users make specific transducer movements to optimize and capture a diagnostic-quality image. In contrast, other ultrasound systems rely on years of expertise to recognize anatomical structures and make fine movements, limiting access to clinicians with specialized training.

The accelerated FDA review process was prompted by urgent requests from clinicians at leading hospitals across the country caring for patients with COVID-19. Letters from individual physicians at Yale, ChristianaCare, Northwestern Medicine, the University of Chicago Medicine, and other medical centers were shared with the FDA, detailing how Caption AI could enable rapid assessment of cardiac function, reduce the risk of exposure for personnel, and stretch limited resources in hospital emergency rooms and ICUs.

"At Northwestern Medicine, we believe AI-based guidance for cardiac ultrasound acquisition will equip our frontline providers to perform these exams with limited training," said Dr. Akhil Narang, a cardiologist at Northwestern Medicine. "This will have a significant impact in our response to COVID-19 while minimizing exposure for our sonographers."

The new version of Caption Guidance, part of the Caption AI software platform, includes 88 percent more types of guidance, improved algorithm performance, and optimized workflow. The technology allows clinicians without specialized echocardiography training to capture images at the point of care, which is consistent with recommendations from the American Society of Echocardiography for how to reduce risk of exposure to the Coronavirus and conserve use of personal protective equipment (PPE).

"Given the shortage of individuals who can perform cardiac ultrasound in our institution and our desire to limit exposure to patients with COVID-19 to the frontline providers treating them, we are looking to teach these COVID-19 frontline providers, such as nurses, APPs, and physicians, to perform cardiac ultrasound exams," said Dr. Chris Moore, an emergency medicine physician at Yale. "However, we are aware of how challenging the exam is to learn and perform. Given the time-sensitivity and importance of this, we need a fast and effective way of getting frontline providers adept at performing cardiac ultrasound exams."

A recent study in JAMA Cardiology reported COVID-19 patient mortality to be 15 times higher among hospitalized patients with cardiac injury. In addition, patients with underlying cardiovascular disease are at higher risk of contracting COVID-19 and have a worse prognosis. According to guidelines from the American College of Cardiology, COVID-19 patients demonstrating heart failure, arrhythmia, ECG changes, or cardiomegaly should have an echocardiogram (diagnostic cardiac ultrasound).

"Caption AI provides clinicians with the ability to quickly and accurately perform potentially life-saving ultrasound exams where and when they are needed most," said Andy Page, chief executive officer of Caption Health. "We are proud to assist those on the front lines of this pandemic who are risking their lives to care for patients. We applaud the FDA for their rapid response to the challenges faced by hospitals during this pandemic and for working to provide them with new technologies that improve care and save lives."

Today's news follows the FDA's announcement in February, when it first authorized Caption Guidance via the De Novo pathway after review under the FDA's Breakthrough Devices Program. The granting of this De Novo was groundbreaking, as Caption Guidance became the first, and remains the only, medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition.

The Caption AI platform also includes Caption Interpretation™, which automatically reviews the clips from a cardiac ultrasound exam, rates them according to image quality, and selects the best ones to calculate the patient's ejection fraction (EF)—the most widely used measurement to assess cardiac function. Following a recent policy announcement by the FDA, Caption Health is making an update to Caption Interpretation available to help providers better address COVID-19. This update can produce an automated EF calculation from the parasternal long-axis (PLAX) view, in addition to the apical 4-chamber (AP4) and apical 2-chamber (AP2) views. Under this policy, Caption AI is the first software available to providers that incorporates the PLAX view in its automated calculation, which can be readily obtained at the point of care.

Caption AI software is currently available fully integrated with a Terason 3200T full-service ultrasound system, which supports scanning of lung, vascular, and other applications.

For more information about Caption AI, clinicians can view the following resources:

• Dr. Randolph Martin, CMO of Caption Health, and two physicians recently discussed how Caption AI is being used to evaluate COVID-19 patients on the webinar: Imaging's Role in COVID-19: A conversation among colleagues.
• Dr. Akhil Narang, Assistant Professor of Medicine, Division of Cardiology at Northwestern University Feinberg School of Medicine, recently presented data on use of Caption AI on 240 patients by 8 Registered Nurses at the 2020 American College of Cardiology Virtual Conference: Acquisition of Diagnostic Echocardiographic Images by Novices Using a Deep Learning Based Image Guidance Algorithm.

About Caption Health
Caption Health was founded in 2013 on a simple but powerful concept: what if we could use technology to emulate the expertise of highly trained medical experts and put that ability into the hands of every care provider? Our vision is to move specialty diagnostics and decision making to the point of care for every patient exam. We are developing AI software that empowers healthcare providers with new capabilities to acquire and interpret ultrasound exams. For more information, go to www.captionhealth.com.

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