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Olympus picks up pediatric indications from FDA for duo of single-use bronchoscopes

February 24, 2026 By Sean Whooley

Olympus FDA clearance pediatric indications two single-use bronchoscopes (1) (1)
[Image courtesy of Olympus]
Olympus announced today that it received FDA clearance for pediatric use for two of the single-use bronchoscopes it distributes in the U.S.

Center Valley, Pennsylvania-based Olympus Corp. of the Americas distributes the H-SteriScope single-use video flexible bronchoscopes in the U.S. Hunan Vathin Medical Instrument Co. manufactures the scopes. Used in respiratory care, the scopes feature 90° rotation left and right, 210° angulation up and down and passive bending for enhanced maneuverability.

The FDA granted Vathin Medical 510(k) clearance of a pediatric use indication for its Zero BCV1-02 and Slim BCV1-C2 model bronchoscopes. 

Zero BCV1-02 has a 2.2mm distal end for pediatric use in children aged six months to six years. Slim BCV1-CG has a 3.2mm distal end and a 1.2mm working channel. It received approval for pediatric use in ages six and older.

Olympus said it now offers both bronchoscopes indicated for pediatric use in the U.S. Both scopes have compatibility with the DVM-B2 digital video monitor from Vathin. The portable, 12.1-inch monitor allows for ease of care in critical or emergent situations. It can attach to an IV pole at the bedside or mount on a nearby cart. Olympus also serves as the exclusive U.S. distributor for that system, too.

“Olympus is very pleased to announce the pediatric indication for the Zero and Slim H-Steriscope bronchoscopes. Patient focus is at the core of everything we do as Olympus strives to provide physicians with the tools they need to help improve patient outcomes,” said Jeff Schmitt, SVP and GM, Respiratory. “Olympus’ bronchoscopy portfolio offers the right scope for the right patient in the right situation.”

Filed Under: 510(k), Business, Distribution Agreements, Endoscopes, Regulatory, Technologies & Devices Tagged With: fda, olympus

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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