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Medical Devices / Submissions and Approvals

FDA Grants De Novo Clearance for Parathyroid Tissue Detection Devices

Nov. 12, 2018

Medical devicemakers Fluoptics and AI Biomed received FDA de novo clearances for their parathyroid tissue detection devices.

Fluoptics received clearance for its Fluobeam 800, which causes parathyroid tissue to glow and eliminates the need for a contrast agent. AI Biomed was cleared for its parathyroid detection PTeye system, which uses both audio and visual alerts to indicate tissue presence.

The systems are used during surgical procedures, such as thyroidectomies and parathyroidectomies, to show the real-time location of parathyroid tissue.

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