FDA Approves Marketing AI Technology to Help Diagnose Wrist Fractures
The FDA signed off on the marketing of an artificial intelligence program for easier detection of wrist fractures.
Imagen’s OsteoDetect uses an AI algorithm to analyze wrist X-rays in a variety of environments.
The FDA reviewed OsteoDetect through the De Novo premarket review pathway for low-to-moderate-risk devices.
Roche Recalls Additional Accu-Chek Test Strips That Produce Biased Results
Roche recalled another of its Accu-Chek glucose meter test strips because of faulty readings.
The company said that in rare cases, the Accu-Chek Inform II test strips can report values that are too high or too low, despite the meter’s fail-safe design. The same issues have also been detected in lots of the company’s Accu-Chek Performa and Accu-Chek Aviva devices.
The company said it investigated the root cause of the issue and has begun implementing corrective measures.