The US Food and Drug Administration (FDA) has expedited clearance of an update to software from Caption Health, a medical artificial intelligence (AI) company, that is designed to aid frontline healthcare workers to perform diagnostic-quality cardiac ultrasounds.
Following a review of just 25 days—faster than 99% of FDA clearances since 2015—the FDA cleared an updated version of Caption Guidance, the AI-guided medical imaging acquisition system.
The accelerated review process was prompted by requests from clinicians at hospitals across the USA caring for patients with COVID-19. Letters from individual physicians at Yale, ChristianaCare, Northwestern Medicine, the University of Chicago Medicine, and other medical centres 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.
Caption Guidance emulates the guidance of an expert sonographer by providing over 90 types of real-time instructions and feedback, Caption Health said in a press release. These visual prompts help users make specific transducer movements to optimise and capture a diagnostic-quality image. In contrast, other ultrasound systems rely on years of expertise to recognise anatomical structures and make fine movements, limiting access to clinicians with specialised training.
“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 Akhil Narang, a cardiologist at Northwestern Medicine (Chicago, USA). “This will have a significant impact in our response to COVID-19 while minimising exposure for our sonographers.”
The new version of Caption Guidance, part of the Caption AI software platform, includes 88% more types of guidance, improved algorithm performance, and optimised workflow, Caption Health said in its press release. 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 Chris Moore, an emergency medicine physician at Yale (New Haven, USA). “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 hospitalised 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.”
The US FDA in February authorised Caption Guidance via the De Novo pathway, after review under the Breakthrough Devices Program.