SynthMed Launches FDA-Cleared Diagnostic Assistant for Radiology Workflows

AI · 5 min read

SynthMed announced FDA clearance for its AssistAI module, which triages chest radiographs and prioritizes cases with suspected pneumothorax, consolidation, and severe effusion. The product is designed to slot into existing PACS and RIS systems, automatically flagging urgent studies and generating structured notes for radiologist review.

The company says AssistAI reduces time-to-read for critical findings by routing flagged cases to on-call radiologists and enabling radiographers to capture follow-up imaging. SynthMed offers both on-prem and cloud-hosted deployment options, with options for hospitals concerned about PHI to keep inference inside their network.

Chief Medical Officer Dr. Lila Patel said the FDA clearance reflects robust clinical validation across community and academic centers. SynthMed plans to expand the assistant to additional modalities and is exploring partnerships with teleradiology providers to scale urgent-care coverage.