The U.S. Food and Drug Administration (FDA) has approved Medo.ai's AI-based thyroid ultrasound system.
Medo-Thyroid uses artificial intelligence to simplify thyroid ultrasounds through a faster and more accurate diagnosis — the company said it's the world's first tool to do this.
It uses algorithms to automatically analyze scans of the thyroid gland, then locates, measures, and characterizes nodules or lumps using the existing Thyroid Imaging Reporting and Data System (TI-RADS).
"We applied artificial intelligence to make the process fast, so (caregivers) no longer have to fish around. They can just take a sweep instead, and then our AI automatically takes over and identifies the measurements with no assistance at all. It will then come up with TI-RADS classifications, which are used to determine whether (nodules) are cancerous or problematic enough that they require a biopsy," Medo.ai co-founder David Quail told Taproot.
"The (current) process is problematic because the scan is subjective and it takes a lot of time," said Quail. "It's basically required from the sonographer to capture 2D images of a three-dimensional anatomy, so it's a really long and error-prone process."
Quail told Taproot that the Medo-Thyroid creates and analyzes 3D images from ultrasounds, which enables users to obtain more accurate results in a shorter period of time than the traditional method.
"The FDA approval means that we could now sell (Medo-Thyroid) in the U.S., but we still have a lot of work to do. Getting clearance from Health Canada is in the works. We hope to get this product cleared in Canada by the end of this year," he said.
The approval is the second FDA clearance that Medo.ai has secured in less than a year. In June 2020, the company was granted clearance for its AI-based solution to diagnose hip dysplasia, which affects infants. If diagnosed early, the condition can be treated with a simple harness worn by the child for a few weeks.
Medo's vision is to make its technology accessible to everyone, including those who live in remote areas, Quail said.
"It's no longer about this elite level of care (with) highly-trained radiologists and hospitals, which are reserved for those patients who drive in and get this expert diagnosis done."