Aidoc announced Monday, Jan. 13, that its AI solution for detecting large-vessel occlusions (LVOs) in head CTA examinations has gained FDA clearance.
The newly cleared module automatically alerts healthcare providers when an LVO is detected, ensuring that the urgent case moves to the top of the radiologist’s worklist. This is the company’s fourth FDA clearance for an AI solution overall and its first since June 2019.
“With our fourth 501(k) clearance, Aidoc is leading the way in radiology AI with the most comprehensive FDA-cleared AI triage package,” Gal Yaniv, MD, chief medical officer of Aidoc and a practicing endovascular neurosurgeon and neuroradiologist, said in a prepared statement. “I'm proud that Aidoc's FDA-cleared AI solutions for flagging pulmonary embolism, cervical spine fractures and intracranial hemorrhage are in full clinical use, saving lives in more than 300 medical centers across the world.”
“Stroke is the ultimate time-critical condition,” Marcel Maya, MD, Cedars-Sinai Medical Center in Los Angeles, said in the same statement. “The faster we can identify, diagnose and treat it, the better the outcome for patients. Aidoc's comprehensive stroke package flags both large vessel occlusion and hemorrhages inside our existing workflows, ensuring we can diagnose stroke faster and decide on the best course of treatment. We're already seeing how this has a positive impact on department efficiency and patient length of stay.”