Optima Neuroscience (Alachua, FL) has announced that FDA has approved the company’s software package that detect seizures from long-term EEG recordings. The development of the IdentEvent™ algorithm began at the University of Florida, and the software has now shown an exceptional sensitivity and specificity to detect seizure activity.
From the press release:
Optima’s IdentEvent 510(k) submission was supported by the pivotal clinical trial of its groundbreaking seizure detection technology… In a side by side comparison with the current market-leading product, Optima’s clinical performance drastically surpassed the competition by generating 85% less false detections (2 per day v. 13+ per day), while offering comparable sensitivity.
“IdentEvent’s ability to accurately identify seizures will make it the most clinically-useful EEG review software on the market.” reports Dr. J. Chris Sackellares, Chief Scientific Officer. “Our technology’s drastic reduction in false detections will allow the neurologist to focus only on the areas of a recording that are of clinical interest. Given the limited number of subspecialists trained to interpret EEGs, IdentEvent will allow for more efficient and cost-effective diagnosis and management of patients suffering from seizure disorders.”