The San Francisco-based company plans to incorporate Caption Guidance technology into compatible ultrasound devices and offer that product to the market as Caption AI.
Caption AI is designed to allow for quick and accurate ultrasound performance by offering clinicians real-time guidance, automated interpretation and quality assessment capabilities. Caption Health said Caption AI is currently under review by the FDA.
“Caption Health’s AI technology occupies a unique space in healthcare because it is designed to enable a broader set of healthcare providers to use ultrasound, a powerful and safe diagnostic tool,” CEO Andy Page said in a news release. “We are rapidly moving toward commercialization of Caption AI and our vision of moving specialty diagnostics to the point of care.”
“The recent milestones we have achieved are inspiring, and I’m excited about our future as Caption Health,” added president & co-founder Charles Cadieu. “Since our founding, we’ve focused on developing and refining our products and have refrained from offering details about our market readiness. We strongly believe that actions speak louder than words and are proud to share these promising developments.”
Caption Guidance software has been granted FDA breakthrough device designation and has undergone a prospective, multi-center pivotal clinical study, for which Caption Health expects full results to be published in early 2020.
In the release, the company said that eight registered nurses with no previous cardiac ultrasound experience used Caption Guidance in 240 limited exams after a short training course. Each exam was assessed by a panel of five cardiologists to determine if it had the quality to make a set of specific qualitative visual assessments.
Caption Guidance met all four of its primary endpoints and met the criteria that more than 80% of exams had the quality for the clinical assessments. Limited echo exams for left ventricular size, left ventricular function and pericardial effusion had 98.8% success rates, while right ventricular size had a success rate of 92.5%, the company noted.
“This is a landmark study of a breakthrough application of artificial intelligence in healthcare, and the top-line results are very promising,” said principal investigator Dr. Akhil Narang, a cardiologist at Northwestern Medicine. “Caption AI’s unique technology offers the potential to empower more healthcare providers to perform ultrasound, including nurses, who are often the first point of care for patients.”