Israel's Zebra Medical Vision announced Monday that the US Food & Drug Administration has approved its AI-based software that helps radiologists identify and prioritize mammograms with abnormal findings.
The FDA clearance is the sixth received by the medical imaging analytics company, and the first in the field of oncology. The FDA previously approved Zebra Medical's solutions using X-rays and CT scans to detect such serious issues as spinal fractures and brain bleeds.
The solution, dubbed HealthMammo, leverages automated AI to detect suspicious lesions. The software categorizes an image as "suspicious" or "not suspicious" and then sends it to the medtech company's imaging analytics platform for analysis and processing. Radiologists later receive the results via a dedicated application. The solution is intended for use with 2D mammograms.
The ability to more quickly identify patients with abnormal findings can result in more accurate diagnoses, thus helping to save lives. The early detection can also reduce the backlog due to cancellations or postponements as a result of the COVID-19 crisis.
“With this fully commercial and regulated product, we aim to provide even more value and help patients and providers navigate the new COVID-effected reality we are all facing,” said CEO Ohad Arazi.
According to the company, Zebra Medical is the first startup to secure FDA clearances for AI technologies in CT, X-ray, and mammography. The company founded in 2014 is said to have deployed its solutions on five continents and raised nearly $60 million from investors.