Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver? AI could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fully-functioning autonomous surgical systems. […]
FDA sets approval record, lays out 2019 strategy
FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015. Novel-device approvals in 2018 included an expanded approval of an […]
How AI can diagnose a leading cause of blindness
The study that led the FDA to approve an AI system for diagnosing diabetic retinopathy came out today, revealing how one of the leading causes of blindness can be detected in a primary care physician’s office. Published in the journal Nature Digital Medicine, the pivotal study of IDx-DR on 900 adults with diabetes showed 87% sensitivity, 90% specificity, and a 96% […]
FDA approves first AI-powered device to detect diabetic retinopathy
The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes. IDx’s software uses an algorithm to analyze images of the eye taken with a retinal camera. A doctor uploads the images to a cloud server with IDx-DR software, which then tells the physician […]
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