The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency’s Safer Technologies Program.
FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of treatments or diagnostics. These are aimed at underlying diseases or conditions that are less serious than those eligible for the breakthrough program.
These devices should improve on existing diagnostics’ or treatments’ safety by reducing adverse events, device failures, use-related hazards or user errors or by improving the safety of other devices or interventions.
In a news release, the FDA said it intends for the program to offer patients more timely access. It does this by expediting product development, assessment and review. However, the FDA says it maintains its standards for safety and effectiveness, data requirements and quality of review.
Endolumik received the 510(k) clearance for its fluorescence-guided gastric calibration tube (FG Bougie). It offers visualization during gastric and bariatric surgical procedures. The tube serves as a sizing and measurement guide during gastric resection, to facilitate stomach decompression, drainage of gastric fluids, and testing for staple line leaks.