Shots:
- The US FDA has granted 510(k) clearance to a new software for the Ceribell System that converts raw EEG information into simplified easy-to-read trends, helping clinicians monitor changes in brain activity
- The update adds Alpha-Delta Ratio & Relative Alpha trending for detecting early signs of brain distress & reduced blood flow in high-risk pts, Burst Suppression monitoring to support sedation management, & Amplitude-Integrated EEG (aEEG) for long-term monitoring of background brain activity
- The clearance has no age restriction, enabling the same easy-to-use trends from premature newborns to adults. Ceribell expects to deliver the features through an automatic software update in H1’27
Ref: Ceribell | Image: Ceribell | Press Release
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