FDA Clears Endolumik Gastric Calibration Tube

The FDA has cleared the first medical device under the agency’s Safer Technologies Program (STeP) — Endolumik’s fluorescence-guided gastric calibration tube, which uses near infrared light to allow surgeons to see the tube through the gastric wall during gastric and bariatric surgical procedures.

The fluorescent device, which enables surgeons to avoid estimating the tube’s location during surgical procedures, should reduce adverse events caused by poor visualization, the Morgantown, Va.-based company said.

The FDA launched the STeP program in 2021 to create an expedited review pathway for devices and device-led combination products that could improve the safety of treatments for diseases or conditions considered less serious than those eligible for the Breakthrough Devices program.