Aidoc has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for First Read, an artificial intelligence solution created to assist radiologists by analysing chest radiographs and producing an initial draft of radiology reports. T
he recognition supports the development of technologies that address significant unmet clinical needs and improve the diagnosis of serious conditions.
The designation comes as healthcare providers face rising imaging volumes, longer reporting times and a shortage of radiologists.
First Read is intended to streamline the reporting process by preparing accurate draft reports from imaging findings, allowing specialists to dedicate more time to clinical review, diagnosis and patient management.
The solution is based on the same technology framework as Aidoc’s FDA-cleared abdominal CT triage application, bringing proven AI capabilities into radiology reporting.
It has been developed with safeguards that keep radiologists responsible for reviewing, editing and approving every report before clinical use, supporting both quality and patient safety.
This is the second FDA Breakthrough Device Designation awarded to Aidoc within a year, following the company’s CARE Triage programme.
Aidoc’s enterprise AI platform is currently used in nearly 2,000 hospitals worldwide and has processed more than 120 million patient examinations.
In April, the company also completed a US$150 million Series E funding round, supporting further innovation and wider adoption of its AI technologies across healthcare organisations.
