Another FDA green light for Zebra

The FDA has OK’d the sixth medical AI application developed by Israel-based Zebra Medical Vision. The latest iteration helps breast-specialized radiologists by flagging questionable lesions appearing in 2D mammograms.

In an announcement, Zebra says the product indicates “suspicious” or “not suspicious,” automatically sending the exams to the company’s imaging-analytics platform for analysis. The results of the analysis then go to the radiologist as either as a worklist signal or a notation in a dedicated application.

Zebra says the product, HealthMammo, is the first of its AI applications to enter the oncology space.

Previous clinical indications for which the company has received FDA 510(k) clearance include vertebral compression fractures, intracranial hemorrhage and osteoporosis.

The company’s CEO, Ohad Arazi, notes the timing of HealthMammo’s approval in light of the pandemic.

“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,” Arazi says in the announcement.