AI Screening System For Blindness Associated With Diabetes Gets FDA Nod
Executive Summary
The US FDA has cleared an AI-based diagnostic from Israeli firm AEYE Health that screens for diabetic retinopathy, a leading cause of blindness.
You may also be interested in...
HLTH 2022: NuraLogix Demo AI Models That Can Predict Risk For Pre-Diabetes
NuraLogix developed machine-learning models that use facial blood flow patterns to predict disease. The company plans to pursue US FDA de novo authorization for its blood pressure monitoring module first in 2023.
FDA Takes Another Swing At Banning Electrical Shock Devices
The US FDA wants to ban devices that use an electrical shock to stop aggressive behavior. The agency attempted to ban the devices in 2020 but failed after it was challenged in court.
Congress Revives Talks On LDTs With Clock Ticking On FDA Rule
During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.