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BioWorld - Saturday, April 18, 2026
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Home » FDA OKs Longeviti’s Clearfit implant for ultrasound
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FDA OKs Longeviti’s Clearfit implant for ultrasound

Jan. 26, 2021
By Meg Bryant
Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.
Medical technology Regulatory Imaging Neurology/psychiatric 510(k) FDA

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