Longeviti Neuro Solutions today announced that it received FDA 510(k) clearance or its ClearFit implant for use in ultrasound in post-operative imaging.
ClearFit’s FDA clearance allows the device to be used during ultrasound procedures, which carries the risk of radiation exposure with other current post-neurosurgical imaging modalities.
“It is our hope that with this new clearance from the FDA, more surgeons will leverage the ClearFit implant for the benefits to them and their patients. There is no other implant on the market that both reconstructs a patient’s skull, and has FDA clearance for post-operative imaging using ultrasound,” CEO Jesse Christopher said in a news release.
The ClearFit implant is a near reconstructive implant that reconstructs a patient’s cranium. The implants are patient-specific prosthetics that correct and restore bony voids and defects of the cranium.
“Using ultrasound in post-operative imaging is something …