SafeOp Surgical said it won 510(k) clearance from the FDA for its EPAD neuromonitoring device.
The Stamford, Conn.-based company develops technology used to detect peripheral nerve damage caused by nerve compression or stretching.
SafeOp bought the tech from Impulse Monitoring after it was sold to NuVasive Inc. (NSDQ:NUVA) for $80 million in 2011, according to its website.
The EPAD device tracks somatosensory evoked potentials to reveal positioning effect, or damage to peripheral nerves incurred from patient placement during surgeries, according to a press release.
“Positioning effect is likely under-diagnosed and, despite caregivers’ best efforts, can occur in a significant number of surgeries. Until now it has often been considered a cost of doing surgery. As surgeries become longer and more complex, and utilize sophisticated technologies such as robotic assistance, a greater potential for positioning effect exists. Our system will proactively assist caregivers in deciding when to intervene and seeing if their intervention has made a difference. We also expect anesthesiologists to appreciate the EPAD’s easy and accurate suite of protocols for one-touch assessment of the NMJ when using paralytic agents,” chief medical officer Dr. Richard O’Brien said in prepared remarks. “Where comprehensive neuro-monitoring with a technician and neurologist is not indicated, but positioning effect or paralytic effect remains an issue, our system adds vital information at minimal cost.”
Chris Walker contributed to this report.
