FDA approves gastrointestinal device

This story was originally published on the University Record by Alana LaRoche from Innovation Partnerships.

The United States Food and Drug Administration has approved a device developed at the University of Michigan that allows clinicians to diagnose and predict treatment outcomes for individuals with chronic constipation far earlier than other methods.

Development of the innovative Rectal Expulsion Device, or RED, was spearheaded by Eric Shah, clinical associate professor of internal medicine in the Medical School and William D. Chey, the H. Marvin Pollard Professor of Gastroenterology, professor of internal medicine and section head of gastroenterology in the Medical School.

Their vision was to move beyond merely developing a product, focusing instead on understanding the broader healthcare challenges that patients face — particularly the fragmented care pathways that delay effective treatment.

“Currently, patients with chronic constipation see their primary care doctor who may prescribe different laxatives. If they don’t work, the patient is referred to a gastroenterologist who typically tries more laxatives,” Shah said.

“When that doesn’t work, the doctor might consider specialized testing to understand why laxatives aren’t working. Unfortunately, because of the complexity and cost, only a minority of doctors have access to this specialized testing.

“The RED device allows any doctor seeing these patients a simple way of identifying constipated patients who will benefit more from physical therapy and biofeedback rather than laxatives alone.”

With a simple tube and balloon mechanism, the device can diagnose constipation-related pelvic floor problems during a patient’s initial visit to a primary care office.

This immediate assessment determines whether physical therapy is required, bypassing unnecessary care referrals and reducing the time and financial burdens on patients and clinics alike.

Critical to the success of this project was the MTRAC Life Sciences Innovation Hub, a statewide program supporting translational research projects with commercial potential from Michigan’s universities, research institutions and hospital systems, with the goal of impacting human health.

The program is co-managed by Innovation Partnerships and the Medical School’s Fast Forward Medical Innovation Program with support from the Michigan Economic Development Corp.

Shah and Chey received an MTRAC Life Sciences funding award for the development and commercialization of RED in 2024.

“Funding sources like MTRAC provide essential resources at stages not typically covered by traditional grants, facilitating the conversion of innovative concepts into market-ready solutions,” said Chey, also a professor of nutritional sciences in the School of Public Health.

“MTRAC funding, in particular, played a pivotal role in our journey, and ultimately cleared the way that led to the device’s FDA clearance.”

With their MTRAC award, Shah and his team were able to collaborate with In2Being, a Michigan-based medical device development firm, to conduct clinical and material testing for the RED prototype.

Additional financial and consulting support was provided by the National Institutes of Health and the American Gastroenterological Association.

Within a year of receiving their funding, RED was licensed to NeurAxis, Inc., an Indiana-based medical technology company, and received FDA 510(k) clearance with the help of Innovation Partnerships.

Innovation Partnerships serves as the nexus of research commercialization at the university.

As a unit within the Office of the Vice President for Research, Innovation Partnerships works with U-M researchers and faculty to advance their innovations and bring them to market.

“What’s truly remarkable is the speed at which Dr. Shah and Dr. Chey transformed the identification of an unmet medical need into an FDA-approved product,” said Kelly Sexton, associate vice president for research – innovation partnerships and economic engagement.

“By leveraging translational research funding through MTRAC and strategic commercial partnerships, we are accelerating the commercialization of breakthrough technologies — ensuring that life-changing advancements reach clinicians and patients faster than ever before.”

On his research commercialization experience, Shah said, “We are incredibly grateful for the Innovation Partnerships and MTRAC Life Sciences teams. RED could not be brought to market without their support. Fostering innovation through programs like these is something the state of Michigan prides itself in, and we are lucky to have such a great ecosystem to bring this commitment to life at U-M.”