RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
Elucid Bioimaging Inc. has already gained an FDA clearance and a CE mark for its Vascucap artificial intelligence-based software that analyzes CT angiograms (CTA) to characterize and quantify atherosclerotic plaque to predict a patient’s stroke risk. But recent interim data presented on July 2, 2020, at the Society for Vascular Surgery conference found that the AI algorithm is more effective than standard-of-care diagnostics.