Aidoc locks down FDA OK for brain aneurysm-spotting AI, its 9th agency nod

In 2018, the FDA opened the floodgates with its first greenlight for Aidoc’s artificial intelligence-powered imaging software—a deep learning-based tool to flag signs of acute intracranial hemorrhage in CT scans—and the ensuing stream of regulatory clearances hasn’t slowed down since.

Less than four years later, the Israeli startup has racked up its ninth nod from the agency, this time for an AI tool designed to automatically identify potential cases of brain aneurysm in head scans.

“In the U.S., there is, tragically, a brain aneurysm rupture every 18 minutes. It’s an acute condition that can quickly turn fatal, so time is of the essence, especially for late-night reading,” said Elad Walach, co-founder and CEO of Aidoc. “We’re excited to include this algorithm in our set of neuro solutions, addressing the challenge of providing timely and accurate notifications of brain aneurysm cases.”

The clearance comes shortly after, Aidoc’s fellow developer of AI-powered imaging analysis software, announced an agency nod for its own aneurysm-spotting tech at the end of February.

Aidoc’s software uses AI and deep learning to assess brain CT scans as soon as they’re complete. Within just a few minutes, if signs of aneurysm are detected, the tool notifies healthcare providers through the Aidoc platform on their computers or mobile devices, where they can look over the findings and, through the platform’s built-in chat and video function, begin planning treatment for the patient.

The aneurysm-spotting software joins a handful of Aidoc’s other tools that have been cleared by the FDA to flag neurological conditions. So far, that includes those to identify large vessel occlusion strokes, intracranial hemorrhage and C-spine fractures.

Beyond the brain, the company has also reeled in the agency’s blessing for several other scan-reading technologies. Most recently, at the end of March, it announced the clearance of its eighth offering, which is designed to triage potential cases of pneumothorax based only on simple X-rays, rather than requiring more complex CT imaging.

To ramp up efforts to bring all of its FDA-cleared solutions to healthcare providers throughout the U.S. and beyond, Aidoc raised $66 million last summer, nearly doubling its lifetime fundraising total to reach $140 million.

The company is also continuing to crank out new scan-reading AI tools and add partners’ software to its platform. In October, for example, it teamed up with ScreenPoint Medical to embed its existing mammogram analysis AI into the Aidoc system to speed up breast cancer detection and diagnosis.