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Outlook Surgical wins FDA clearance for hybrid endoscope system

September 30, 2025 By Danielle Kirsh

Outlook Surgical Inova 1
[Image courtesy of Outlook Surgical]

Outlook Surgical this week announced it received FDA 510(k) clearance for its Inova 1 Towerless Endoscope System.

The Bloomington, Illinois-based company designed the device to combine the features of a rigid and flexible scope into a single platform. It is intended for head and neck procedures, including ENT and related specialties.

Outlook Surgical said instruments can attach directly to the scope to allow for one-handed operation while keeping the working tool in view. The design removes the need for external towers, cameras or light sources, making the system lighter and more portable than existing platforms.

“Surgeons have been working with essentially the same endoscopic technology for decades,” said Willard Noyes, cofounder and chief innovation officer. “Our hybrid system finally bridges the gap: delivering simplicity, improved access, versatility, and efficiency for physicians, while enhancing comfort, outcomes, and cost-effectiveness for patients.”

Key features include a rigid-flexible hybrid design for stability and maneuverability, high-definition imaging transmitted to HDMI monitors or wirelessly, and a compact control box with a built-in screen. The system is also compatible with third-party surgical devices using clip-on adapters.

The company said clinical feedback for the device has been positive, with surgeons citing intuitive use and time savings. The company plans to launch the system in early 2026 and expand its use into office-based ENT procedures, emergency and urgent care, cancer detection, pediatrics, anesthesia, and critical care. Future applications could also include orthopedics, gastroenterology, urology, OB/GYN, and neurosurgery.

“Our mission is to make advanced endoscopic technology more accessible, adaptable, and efficient across the globe,” Noyes said. “This first-generation device is only the beginning. We have a robust pipeline of innovations that will continue to push surgical visualization forward.”

Filed Under: 510(k), Endoscopes, Regulatory Tagged With: Outlook Surgical

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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