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SafeOp Surgical obtains FDA clearance for EPAD neuromonitoring device

SafeOp Surgical has received the US Food and Drug Administration (FDA) clearance to market its Evoked Potential Assessment Device (EPAD), designed to monitor neurological status by recording somatosensory evoked potentials (SSEPs) or assessing the neuromuscular junction (NMJ).

The portable device uses proprietary algorithms, electrodes, and cables, along with Bluetooth technology to allow easy set-up and integration into current operating room practices.

SafeOp president Dr Curt LaBelle said the company is excited to bring neurological monitoring to a greater population of surgical patients in the US market.

"Just as cardiac function and respiratory function are monitored in surgical procedures, we believe that nerve function monitoring will become standard of care in the future, resulting in fewer adverse events for patients," Dr LaBelle added.

SafeOp’s system records SSEPs, which are particularly effective in revealing positioning effect, which refers to damage to peripheral nerves during surgery that is caused by the way the patient is positioned on the surgical table.

Currently, the company is introducing its device to a select number of centers, and anticipates its commercial efforts in the second half of 2014.