On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition. The device, called IDx-DR, utilizes an AI algorithm to screen for diabetic retinopathy. The device is unique in that its results do not require additional review by a specialized clinician, which allows the test to be performed in a primary care setting.
To use IDx-DR, images of the patient's eyes are first taken with a retinal camera and uploaded onto a cloud server where the device is installed. Then, within minutes, IDx-DR provides the doctor with results, indicating whether it detects more than mild diabetic retinopathy, in which case the patient should see an eye specialist, or that the screening was negative and the patient should be tested again in a year.
Like many devices in the digital space, IDx-DR was reviewed through FDA's De Novo premarket review pathway, which is used for novel devices that present a low-to moderate-risk to patients. Additionally, IDx-DR was granted Breakthrough Device designation, which expedites the review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
FDA has consistently stated its intention to be flexible with developers of digital health products whose software and devices often do not fall neatly into long-established product types. The successful utilization of the De Novo and Breakthrough Device programs for IDx-DR should encourage innovation by providing an FDA roadmap for other companies developing software and AI-based medical devices.