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Self-Driving Car Pioneer David Stavens’ Company Earns First 510(k) For AI-Based Teleradiology Tech To Help Triage Brain Injury Patients

 
• By Marion Webb

David Stavens’ company recently gained US FDA clearance for AI-powered software to help radiologists triage intracranial hemorrhage and mass effect from non-emergent cases.

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Nines recently became the first company to gain 510(k) clearance from the US Food and Drug Administration to market an algorithm-based software solution called NinesAI that allows radiologists to triage intracranial hemorrhage and mass effect on computed tomography (CT) scans. Mass effect, which is associated with such conditions as stroke and brain tumor, causes the surrounding areas of the brain to be compressed.

Nines’ co-founder and CEO David Stavens said it will make the technology available to existing and new customers who sign up with the company before 30 June for in-house use...

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