FDA grants de novo clearance to AI Biomed, FluoOptics parathyroid tissue detection devices

The FDA today granted de novo clearance to parathyroid tissue detection devices from both Fluoptics and AI Biomed.

The systems are intended to provide the real-time location of parathyroid tissue during surgical procedures including thyroidectomy and parathyroidectomy, the federal watchdog said.

FluOptics won approval for its Fluobeam 800 clinic imaging device which can be used as a companion to assist in locating parathyroid tissue during surgery, the FDA said. Parathyroid tissue emits a fluorescent glow when exposed to the Fluobeam’s light source, which eliminates the need for a contrast agent.

The system previously won clearance as an imaging system to capture and view fluorescent images for visually assessing blood flow as an adjunctive method of evaluating tissue perfusion, the agency said.

Approval came based on data from five peer-reviewed published studies, including a trial that compared postoperative hypocalcemia (PH) rates post-removal of parathyroid tissue. Results indicated that in 93 patients who underwent procedures with the device, 5% experienced fluctuating PH levels following surgery, lower than the 21% reported on 153 patients who underwent surgery without the device, the agency said.

AI Biomed won clearance for its Parathyroid Detection PTeye system, which is intended to aid in detecting parathyroid tissue by using a probe that emits fluorescent light. The system provides both audio and visual displays to indicate the presence of parathyroid tissue, the FDA said.

The system won approval based on data from a single-blinded study of 81 patients treated with the device, with data indicating that the PTeye system could correctly identify parathyroid tissue as compared to histology 93% of the time, and the absence of such tissue as compared to intraoperative expert visualization 97% of the time. The overall accuracy of the device was reported as 96%, the FDA reported.

“For some patients with parathyroid disease, treatment may mean a surgical procedure. Real-time identification of parathyroid tissue during surgery can provide surgeons with valuable information to help preserve healthy tissue or to remove diseased tissue,” FDA Center for Devices and Radiological Health Division of Surgical Devices director Dr. Binita Ashar said in a press release.