AI software that triages x-rays for pneumothorax receives FDA clearance

Aidoc has received 510-k clearance from the U.S. Food and Drug Administration for its AI software that triages chest radiographs for pneumothorax. 

The company, which also has seven other FDA-cleared AI programs for medical imaging, announced the news in a statement on March 30, sharing excitement for the expansion of their AI solutions into x-ray. 

“We’re very excited about this important milestone,” said Elad Walach, CEO of Aidoc. “This FDA clearance further validates the breadth of our AI platform, going beyond specific AI algorithms to act as a healthcare AI hub for the enterprise’s cross-specialty needs.” 

Left undiagnosed and untreated, pneumothorax can deteriorate a patient’s condition quickly and lead to respiratory or cardiac failure. When radiologists are burdened with overwhelming workloads, detecting these clinically urgent pathologies can be a challenge. Aidoc states that their pneumothorax algorithm can offer a solution for this particular issue by flagging chest x-rays when it detects pneumothorax and then notifying physicians of the suspicious findings, thus prompting a timely interpretation and reducing time-to-diagnosis and time-to-treatment. 

“By bringing radiologists and proceduralists to the same AI platform, we enable enhanced collaboration across departments and systems to deliver patients with the right treatment at the right time,” Walach said. “This includes ER, ICU, outpatient centers, inpatient admissions, and the coordination of care and communication among providers.”