Company Spotlight

Endolumik builds a surgical device that glows. The reason is a blind spot that has complicated gastrointestinal surgery for as long as the procedure has existed.

In a sleeve gastrectomy or hiatal hernia, the surgeon works around a calibration tube, a bougie placed down the esophagus and into the stomach to serve as a sizing guide during the procedure. The problem is that the surgeon mostly cannot see it. The tube sits behind layers of esophagus or stomach and adipose tissue, and poor visualization has led to serious complications: perforation, or even stapling the tube itself. The stakes extend beyond any one operating room. Between 2011 and 2018, the FDA logged more than 41,000 device reports related to surgical staplers and staples, including over 9,000 serious injuries and 366 deaths, and later reclassified the devices to subject them to premarket review.

Dr. Nova Szoka watched the problem from the closest possible vantage point: performing hundreds of bariatric surgeries at West Virginia University hospital. Her answer was to light the tube from within. The Endolumik Gastric Calibration Tube emits near-infrared (NIR) light at the same wavelength as indocyanine green, the imaging dye surgical teams already use, which means the glowing tube is visible to any NIR-capable camera or surgical robot a hospital already owns. No new capital equipment, no workflow rebuild. An integrated suction channel handles decompression and leak testing, cutting down the tool swaps that add time and risk. Szoka founded Endolumik in 2020 with CEO Mara McFadden to take the device from her operating room to everyone else's.

The regulatory milestone that followed put the company in FDA history.

In 2023, the Endolumik Gastric Calibration Tube became the first device of any kind authorized through the FDA's Safer Technologies Program, the agency's pathway for devices that offer meaningful safety advantages, and the device reached the market that year. The evidence base has kept building since: a second U.S. patent covering multi-wavelength near-infrared visualization, adoption by bariatric programs across the country, and, in June 2026, a second peer-reviewed publication documenting the device's use in Roux-en-Y gastric bypass, extending the clinical record beyond the sleeve procedure it started with. Surgeons describe the difference bluntly. Dr. Lawrence Tabone, director of bariatric surgery at WVU Medicine, credits the device with "unparalleled visualization" in constructing consistent gastric sleeves.

The company's build reflects a corridor, not a single city. Endolumik was founded in Morgantown, West Virginia, where the clinical insight lives. The commercialization is led from Pittsburgh. McFadden trained as a mechanical engineer at Berkeley, earned her MBA at Carnegie Mellon, and built her career in medical device product leadership at Johnson & Johnson and Philips Healthcare before co-founding Endolumik. She runs the company from Pittsburgh and serves on PLSA's Industry Advisory Council, one voice in the room shaping how the region grows its life sciences base. It is a fitting base of operations: the greater Pittsburgh region is home to 68+ medical device manufacturers, with the regulatory, supplier, and talent depth that concentration brings. A device invented seventy-five miles down I-79 is being scaled with Pittsburgh operating experience.

"Now that we have established product-market fit, we are excited to use the talent in this region to grow from a single device company into a broader surgical vizualization company," - McFadden on commercializing a medical device from Pittsburgh.

Endolumik is still a small company, and that is part of what makes the record notable: a surgeon-founder, a six-person team, an FDA first, three patents, and a growing publication list. Every operating room with NIR imaging, and every surgical robot with a fluorescence mode, is already equipped to see what the device shows. The addressable market was installed before the company arrived. What comes next is expansion along the evidence: more procedures, more programs, more of surgery's blind spots lit up.