Dragonfly™ Pancreaticobiliary Scope System Receives FDA 510(k) Clearance for the World’s First and Only 360° Rotatable Pancreaticobiliary Scope

Englewood, CO, April 22, 2025 --(PR.com)-- Dragonfly™ Endoscopy Inc., a pioneer in next-generation endoscopic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a novel 360° Rotatable Pancreaticobiliary Scope System — the first and only device of its kind which is purpose-built to elevate the standard of care in cholangioscopy and pancreatoscopy. This milestone marks meaningful progress toward overcoming long-standing challenges in pancreaticobiliary care.

“This technology receiving FDA clearance is a defining moment for the field of endoscopy. This innovation was born from a deep understanding of the challenges physicians face in managing complex pancreaticobiliary conditions — and a relentless drive to solve them. We're proud to deliver a tool that enhances precision and expands therapeutic options during ERCP procedures.” — Jeremy Starkweather, CEO, Dragonfly™ Endoscopy Inc.

The Dragonfly™ Pancreaticobiliary Scope System features a slim 10.5Fr catheter, a large 1.7mm working channel, and advanced capabilities for biopsy and lithotripsy — empowering physicians with greater precision and control for both diagnosis and treatment.

Each year, more than 650,000 ERCP procedures are performed in the United States to diagnose and treat disorders of the liver, bile ducts, and pancreas.¹ When further intervention is required, cholangioscopy and pancreatoscopy offer direct access to these ductal systems, allowing for targeted biopsies, mucosal evaluation, and stone therapy.²

Dragonfly™ Endoscopy Inc. has initiated a limited U.S. commercial launch, with early procedures already performed at leading endoscopy centers in collaboration with expert endoscopists. Full commercial availability is anticipated in mid-2025.

About Dragonfly™ Endoscopy Inc.
Founded in 2018, Dragonfly™ Endoscopy Inc. is focused on developing and commercializing breakthrough technologies that elevate the standard of care for patients suffering from pancreaticobiliary disease.

For more information, visit www.dragonflyendoscopy.com and follow us on LinkedIn.

Media Contact:
9800 Pyramid Ct., Suite 400
Englewood, CO 80112
info@dragonflyendoscopy.com

¹The Future of Endoscopic Retrograde Cholangiopancreatography - Gastroenterology. 2017 Aug;153(2):338-344.
²CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association