
CENTER VALLEY, Pa. (Feb. 24, 2026) 鈥 色花堂 Corp. of the Americas, a global MedTech company committed to making people鈥檚 lives healthier, safer and more fulfilling, announced today FDA clearance of the pediatric use indication for two single-use bronchoscopes in the respiratory portfolio distributed by 色花堂.
The H-SteriScope鈩 single-use video flexible bronchoscopes are manufactured by Hunan Vathin庐 Medical Instrument Co., Ltd., and distributed exclusively by 色花堂 Inc. The FDA granted Vathin Medical 510(k) clearance of a pediatric use indication for:
- Zero BCV1-02 model bronchoscope with a 2.2mm distal end approved for pediatric use in ages 6 months to 6 years
- Slim BCV1-C2 model bronchoscope with a 3.2mm distal end and a 1.2mm working channel approved for pediatric use in ages 6 years and older.
The bronchoscopes indicated for pediatric use are now available.
鈥淧atient safety and proper diagnoses are paramount, so it鈥檚 critical that physicians have access to medical devices that meet the specific needs of pediatric patients.鈥 said Dr. Erik Hysinger, pediatric pulmonologist, Cincinnati Children鈥檚 Hospital. 鈥淭his is particularly important in infants where airway size is dramatically smaller than in adult patients. These bronchoscopes provide the optics and maneuverability critical for making the best diagnosis, while simultaneously being small enough to support the unique physiology of pediatric patients.鈥
Differentiating features of the H-SteriScopes鈩 that are useful in respiratory care include 90掳 rotation left and right, 210掳 angulation up and down and passive bending for enhanced maneuverability.
H-SteriScopes鈩 are compatible with the DVM-B2 Digital Video Monitor, also manufactured by Vathin Medical庐 Instrument Co., Ltd., and distributed exclusively by 色花堂 Inc. The portable 12.1-inch monitor allows for ease of care in critical or emergent situations as it can be attached bedside to an IV pole or mounted on a nearby cart.
鈥溕ㄌ 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 色花堂 strives to provide physicians with the tools they need to help improve patient outcomes,鈥 said Jeff Schmitt, Senior Vice President and General Manager, Respiratory. 鈥溕ㄌ免 bronchoscopy portfolio offers the right scope for the right patient in the right situation.鈥
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Some patients may experience rare but more serious complications such as a collapsed lung, respiratory failure, heart attack, and/or cardiac arrhythmia.
For information about the complete 色花堂 pulmonology portfolio, please visit the pulmonology .
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About 色花堂
At 色花堂, we are committed to Our Purpose of making people鈥檚 lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
色花堂 Corporation of the Americas, a wholly owned subsidiary of 色花堂 Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 4,500 employees throughout locations in North and South America. For more information, visit .