software gains FDA clearance for automatically spotting brain aneurysms

After receiving regulatory clearances for its artificial intelligence programs for quickly spotting a stroke, has secured a new FDA green light aimed at another life-threatening brain condition: cerebral aneurysms.

Like its previous offerings, the company’s cloud-based system analyzes CT scans for signs of a weakened or distended blood vessel in the brain, which can potentially rupture if left untreated. If discovered, the program works to automatically notify neurovascular specialists.

Manually diagnosing aneurysms within the brain’s vascular maze can be tricky, with many cases often going undetected, according to the company, which estimates that about 3% of the U.S. population may be carrying an aneurysm, while about 30,000 suffer from hemorrhaging ruptures annually with a mortality rate of about 40%.

RELATED: Medtronic to distribute's stroke-spotting AI imaging software’s aneurysm module will be added to its digital care coordination platform—covering ischemic and hemorrhagic stroke, cerebral perfusion, pulmonary embolisms and aortic disease—which the company said is currently being used in more than 1,000 hospitals.

Its first computer-driven triage program, aimed at large vessel occlusions in the brain, was first cleared by the FDA in early 2018. That system received a European approval with a CE mark in June of last year—not long after raising $71 million in a series C venture capital round to help develop programs in multiple acute care areas and boost its global commercial reach.

RELATED: Stroke-spotting software maker raises $71M to expand clinical reach

More recently, announced a partnership with the remote care provider TeleSpecialists earlier this month. Starting with strokes and large vessel occlusions,’s platform will connect providers on the ground with TeleSpecialists’ neurologists for a virtual consultation. The two companies said they would also collaborate on additional hospital workflows and research.