Israel’s Zebra Medical gets FDA ok for brain bleeds product
TEL AVIV (Reuters) – Zebra Medical Vision, an Israel medical imaging analytics company, said on Monday it received its third clearance from the U.S. Food and Drug Administration for its alert for intracranial hemorrhage, based on head CT scans.
The latest cleared product uses artificial intelligence to automatically identify suspected internal brain bleeds based on head CTs. This can significantly reduce turnaround time and increase the radiologists’ confidence in their diagnosis, Zebra said.
Its product for pneumothorax chest X-rays received FDA clearance in May.
Intracranial haemorrhage accounts for about 10% to 20% of all strokes, and can occur as a result of traumatic injury, ruptured arteries, stroke or cancer. Its 30-day mortality rate ranges from 35% to 52% with about half occurring in the first 24 hours.
Reporting by Tova Cohen, Editing by Ari Rabinovitch