Endolumik Expands Gastrointestinal Calibration Tube Into Colorectal Surgery, Broadening Its FDA-Registered Platform

Morgantown, WV, September 14, 2026 --(PR.com)-- Endolumik, a medical device company developing fluorescence-guided surgical tools for minimally invasive procedures, today announced it has expanded the labeled use of its Endolumik Gastrointestinal Calibration Tube to include lower gastrointestinal tract surgical procedures, including colorectal surgery.

Previously used in gastric and foregut procedures, the Endolumik device is designed to provide fluorescence-guided visualization while supporting multiple intraoperative applications, including suction, irrigation, insufflation, leak testing, visualization of tube position, and sizing, as relevant. The device first received FDA 510(k) clearance in 2023, when it was the very first device ever authorized under the FDA’s Safer Technology Program (STeP). The colorectal expansion did not require a new 510(k) submission, consistent with the exempt status of the applicable product code. Since launch, Endolumik’s tube has been trusted in surgeries in over 160 hospitals across the US.

“With the expansion into colorectal procedures, we are excited to bring the capabilities of the Endolumik device portfolio to an even broader range of patients and surgeons,” said Mara McFadden, CEO of Endolumik. “We pride ourselves on having our innovation lead by the voice of our customers, and this indication was added due to the strong demand directly from surgeons.”

Darin Minkin, DO, FACOS, FASMBS, was the first surgeon to recommend this application. “I saw the benefit of the increased visualization in helping me do a faster, safer colorectal leak test,” said Dr. Minkin. “You can clearly see the tube’s position as it approaches the staple line.” Dr. Minkin has received compensation from Endolumik for the development of physician education materials.

As with the original device, this expansion was shaped directly by the surgeons who use it. Endolumik remains committed to developing original, clinically driven visualization technology — engineered and validated to rigorous quality standards — that gives surgeons better information exactly when they need it.

Endolumik is a medical device company developing novel tools for laparoscopic surgery. Its patented fluorescence guided surgical tools are designed to help make minimally invasive surgical procedures safer and more effective. Learn more at www.endolumik.com. Endolumik is a certified Women Owned Small Business.