Endolumik Receives FDA Clearance for Flagship Product and Safer Technology Designation

Endolumik, an innovator in minimally-invasive surgical devices, today announced its fluorescence guided Gastric Calibration Tube has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology uses near infrared (NIR) light to allow surgeons to more clearly visualize surgical tools inside the stomach. The device was designated by the FDA as part of their Safer Technology Program, the first device ever approved through that program.

“Our mission is to provide surgeons with additional visual cues to succeed in the operating room.”
– Dr. Nova Szoka

Morgantown, WV, March 09, 2023 –(PR.com)– Endolumik, an innovator in minimally-invasive surgical devices, today announced its fluorescence guided Gastric Calibration Tube has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology uses near infrared (NIR) light to allow surgeons to more clearly visualize surgical tools inside the stomach.

The novel device received an expedited review because it was designated by the FDA as part of their Safer Technology Program, or STEP. According to the FDA, the STEP program is for devices that are “reasonably expected to significantly improve the safety of currently available treatments.” The NIR fluorescence of the Endolumik device is designed to help surgeons avoid adverse events that can be caused by poor visualization. The Agency announced this week that the Endolumik tool was the first device ever authorized under the new program.

“Our mission is to provide surgeons with additional visual cues to succeed in the operating room,” said Dr. Nova Szoka, FACS, FASMBS, the Chief Medical Officer of Endolumik. “We believe the enhanced visualization that our device provides will help surgeons standardize surgical outcomes for sleeve gastrectomy, and this will translate to improved patient outcomes.”

Endolumik is advancing the frontier of fluorescence guided surgical techniques. The recent widespread availability of NIR-capable surgical cameras has opened the door for new capabilities. “Endolumik’s bougie brings light to the blind aspect of the procedure. Allowing surgeons to visualize the bougie through the gastric wall will remove the guessing or estimating portion of the procedure. Relying on direct visualization has the potential to improve the safety and consistency of the procedure,” said Dr. Dan Azagury, FACS, and the Chief of Minimally Invasive & Bariatric Surgery at Stanford University School of Medicine.

The technology also has the potential to expand the use of surgical robotic applications. “I am so proud of this team,” Endolumik CEO Mara McFadden notes, “while this device is the first of its kind, we envision a new generation of surgical tools that use light and digital surgery techniques to enhance surgeon performance.”

With FDA 510(k) clearance, Endolumik will begin real-world clinical use of the Gastric Calibration Tube with select hospitals and health systems this spring. Endolumik’s latest technologies will play a vital role in advancing digital surgery techniques.

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.

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