Devices

2 Devices Cleared for Parathyroid Tissue Detection

FDA has permitted the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands). The clearances were issued to Fluoptics for its Fluobeam 800 Clinic Imaging Device and AiBiomed for its Parathyroid Detection PTeye System.

The Fluobeam is used to assist in the imaging of parathyroid glands and can be used as a companion method to assist surgeons in locating parathyroid tissue visually during surgery, according to an FDA release. Parathyroid tissue emits a fluorescent glow when the device’s light source is shone on it, avoiding the need for a contrast agent. The device was previously cleared as an imaging system used to capture and view fluorescent images for blood flow visual assessment as an adjunctive method for evaluating tissue perfusion.

The Parathyroid Detection PTeye System is intended to aid in detecting parathyroid tissue during surgery by using a probe that emits fluorescence light. Tissue detection is based on how the parathyroid tissue reacts to the fluorescent light, the agency says. When parathyroid tissue is detected, the system provides an audio and visual display to indicate its presence.

“Use of either device is intended to assist, not replace, experienced visual assessment in identifying the parathyroid tissue along with a biopsy to confirm thyroid tissue per standard of care,” FDA says. They are also not intended to be used to confirm the absence of parathyroid tissue or glands and are only to be used to assist the surgeon in locating potential parathyroid tissue or glands.

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