FDA Issues Breakthrough Device Designation for AI CXR Triage Software for Pneumomediastinum and Lung Collapse
The CARE Chest X-Ray (CXR) Triage software reportedly bolsters consistent flagging of suspicious chest X-rays for lung collapse and pneumomediastinum across reviewing readers of different experience levels.
The Food and Drug Administration has granted breakthrough device designation for CARE Chest X-Ray (CXR) Triage, an AI-powered software from Aidoc for triage of chest X-rays with possible pneumomediastinum and lobar or lung collapse.
Pointing out that chest CXR assessments are frequently distributed across clinicians with varying levels of experience (radiology residents, teleradiologists, emergency department physicians, etc.), Aidoc said the CARE CXR Triage software facilitates more timely and consistent interpretation.
Aidoc noted that the breakthrough device designation for CARE Chest X-Ray Triage is the third this year for AI software developed with the company’s CARE foundation model, which facilitates the development of AI-enabled software for triage, measurement, characterization and draft reports for multiple clinical workflows.
"In the perspective of 19 months since launching CARE, we have achieved breakthrough device designations for three devices across different anatomies and modalities. Achieving this, while still meeting the most rigorous safety and quality standards, is what makes CARE different," said Idan Bassuk, the chief R&D and AI officer at Aidoc.
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