Outlook Surgical Obtains FDA 510(k) Clearance for Hybrid Endoscope: A Breakthrough in Surgical Visualization

BLOOMINGTON, Ill., Sept. 29, 2025 /PRNewswire/ -- Outlook Surgical has obtained FDA clearance of its Inova 1 Towerless Endoscope System, a revolutionary advancement that reimagines surgical endoscopy by combining the best features of rigid and flexible scopes in one streamlined platform.

For more than 30 years, surgical endoscopy has relied on either rigid or flexible scopes, each with inherent limitations. Rigid endoscopes provide precision but lack maneuverability, while flexible scopes allow navigation but require two-handed operation. Outlook Surgical's hybrid Inova 1 solution overcomes these barriers, enabling one-handed operation, high-definition visualization, and unmatched procedural efficiency.

"Surgeons have been working with essentially the same endoscopic technology for decades," said Dr. Willard Noyes, Co-Founder and Chief Innovation Officer of Outlook Surgical. "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."

A Next-Generation Surgical Platform

Specifically designed for head and neck procedures, including all aspects of ENT and related subspecialties, the Inova 1 Hybrid Endoscope integrates seamlessly with surgical instruments. The hybrid scope is designed to work hand-in-hand with existing surgical instruments. Instruments can attach directly to the scope, enabling true one-handed operation while ensuring the working tool remains continuously in the field of view. Its innovative design eliminates the need for bulky external towers, cameras, or light sources, making the device lighter, thinner, and more portable than existing systems.

Key features include:

• Hybrid rigid-flexible design: Provides stability while maintaining maneuverability.
• One-handed operation: Instrument integration and streamlined design frees the surgeon's other hand for additional tools, simplifying workflow.
• Crystal-clear HD imaging: Displayed on any HDMI monitor or transmitted wirelessly without internet connectivity.
• Compact control box: Pocket-sized, with a built-in screen enhancing mobility.
• Universal adaptability: Compatible with third-party surgical devices via simple clip-on adapters.

Surgeons Praise Intuitive Design

Early clinical feedback has been overwhelmingly positive. Surgeons describe the device as "intuitive," "timesaving," and "long overdue." Demonstrations at national and international meetings have drawn strong interest from physicians, distributors, and healthcare organizations eager to integrate the system into clinical practice.

Looking Ahead

With FDA clearance secured, Outlook Surgical plans to launch its first-generation Inova 1 endoscope system in early 2026. Beyond the OR, the technology is poised to transform office-based otorhinolaryngologic (ENT) procedures, emergency and urgent care, cancer detection, pediatric, anesthesia, and critical care. Intended future uses will include orthopedic, gastroenterology, urologic, OB/GYN, and neurosurgical applications.

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

About Outlook Surgical

Outlook Surgical is a pioneer in surgical visualization, developing compact, adaptable, and portable hybrid endoscope systems that combine the strengths of rigid and flexible endoscopy. Designed for intuitive one-handed operation and seamless instrument integration, Outlook Surgical's Inova 1 platform enhances efficiency, improves patient outcomes, and expands the possibilities of minimally invasive surgery.

For more information: www.outlooksurgical.com

Company Contacts:
Dr. Willard S. Noyes, MD FACS, Co-Founder, Chief Innovation Officer, & Board Member
[email protected]

Samantha Surrey, M.S.E, Co-Founder & Board Member
[email protected] 

SOURCE Outlook Surgical Endoscopy Systems