AI that flags urgent cases for radiologists gets FDA clearance - MedCity News

Nines, a Palo Alto-based teleradiology startup, received FDA 510(k) clearance for a system that can detect and triage two serious conditions from CT scans. The company's NinesAI system uses machine learning to identify potential cases of intercranial hemorrhage and mass effect, both of which are associated with strokes. The system then flags those cases for expedited review by radiologists. For both of these conditions, every hour counts toward a patient's survival. "This has been a long time coming. A lot of hard work went into it," CEO David Stavens said in a phone interview.