For the Fluobeam 800, the FDA reviewed data from five peer-reviewed published studies, including one study that compared the rate of postoperative hypocalcemia (PH), or a temporary reduction in calcium in the blood, that occurs when healthy parathyroid tissue is inadvertently removed. In 93 patients who had surgery using the device, 5 percent experienced fluctuating PH following surgery compared with 21 percent of the 153 patients who had surgery without the device.

For the PTeye System, the FDA reviewed data from a single-blinded study of 81 patients who had surgery using the device. Results demonstrated that the PTeye could correctly identify the presence of parathyroid tissue as compared to histology 93 percent of the time and correctly identify the absence of parathyroid tissue as compared to intraoperative visualization by an expert 97 percent of the time, with an overall accuracy of 96 percent.


The Fluobeam 800 and the PTeye were reviewed separately but concurrently under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of The Fluobeam 800 Clinic Imaging Device to Fluoptics.

The FDA granted marketing authorization of Parathyroid Detection PTeye System to AiBiomed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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