Artificial intelligence (AI) software developer Bay Labs has changed its name to Caption Health and announced that its flagship echocardiography AI software has been given a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
The deep learning-based technology, formerly known as EchoGPS, also has been renamed as Caption Guidance and will be offered to the market as Caption AI when it receives FDA clearance, according to the vendor. It's designed to enable cardiac ultrasound exams to be performed by healthcare practitioners at various skill levels and includes real-time guidance, automated interpretation, and quality assessment capabilities, Caption Health said. The software will be integrated onto compatible ultrasound scanners.
As part of its participation in the breakthrough device program, Caption Health worked with the FDA to develop a prospective, multicenter, pivotal clinical study that was conducted at Northwestern Medicine and Minneapolis Heart Institute. The study, which evaluated the use of Caption Guidance by eight registered nurses with no prior cardiac ultrasound experience, met all four primary end points, according to the firm.
The company expects that full results from the study will be published in early 2020.
