FDA clears first device authorized under Safer Technologies Program

The FDA cleared a new gastric calibration tube last week, announcing it as the first authorization of a device under the agency’s Safer Technologies Program (STeP).

FDA launched STeP in 2021, modeling the program on its breakthrough devices designation 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 treated or diagnosed by devices eligible for breakthrough designation.

Endolumik received FDA 510(k) clearance for its fluorescence-guided gastric calibration tube (FG Bougie). It offers improved visualization during gastric and bariatric surgical procedures. The tube serves as a sizing and measurement guide during gastric resection and facilitates stomach decompression, drainage of gastric fluids, and testing for staple line leaks.

The device emits near-infrared light so the surgeon can see the tube clearly through thick layers of stomach tissue and body fat. Morgantown, West Virginia-based Endolumik said poor visualization can lead to surgical complications such as perforation, excessive gastric sleeve narrowing and inadvertent stapling of the calibration tube.

More about STeP

STeP devices are those that 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 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.

Original Article: (https://www.medicaldesignandoutsourcing.com/fda-clears-first-device-authorized-under-safer-technologies-program/)