Zyno Medical, LLC Receives FDA 510(k) Clearance for Ambulatory Infusion Pump
A Simple, Safe, and Reliable Ambulatory Infusion System
NATICK, MA., October 17, 2014 – Zyno Medical, LLC today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in addition to European CE Mark for their ambulatory infusion system, and will market it under the trade name “Nimbus”(TM). The Nimbus™ Ambulatory Infusion Pump is designed for the delivery of medications and/or fluids to a patient for subcutaneous, epidural, perineural, and intravenous infusions. Its compact size, high accuracy, high reliability, and low cost is well suited for both clinical and home environments. Zyno Medical, LLC plans to launch Nimbus™ with deployments to select healthcare facilities beginning fall of 2014.
“We are pleased to launch our latest infusion technology that focuses on a safe and effective ambulatory infusion delivery system for patient care, and a cost efficient solution for the clinician in this current healthcare environment,” said Dr. Chaoyoung Lee, the president and owner of Zyno Medical, LLC. “This is a significant accomplishment for the team at Zyno Medical. It exemplifies our commitment to our philosophy, Simplicity equals Safety.” By leveraging Zyno Medical’s experience in infusion technologies, we designed this easy to use infusion system with the patient, nurse and clinician needs in mind.
The ambulatory infusion pump is used in many different healthcare settings such as the hospital, home care and alternate care environments. The Nimbus™ Ambulatory Infusion System combines a simple user interface and reliable technology to create an innovative device for Continuous rate and PCA infusions. Nimbus™ is easy to program, accurate and reliable. It is a cost effective solution for the clinician to meet the changing needs of their ambulatory patient populations. The low profile pump combined with the carrying case allows the patient to complete their daily activities while administering their infusion therapy in a discrete manner.
About Zyno Medical, LLC
Zyno Medical was founded in 2007. The company received its first 510(k) FDA clearance in October 2007 for the Z-800 large volume pump. Zyno Medical’s market focus is the alternate care market where there is a need for durable, advanced technology infusion pumps designed specifically for the infusion needs that are unique for this market. Since its inception, the company has assembled a vast wealth of engineering talent, clinical experience, customer and market expertise. Zyno Medical’s headquarters is in Natick, Massachusetts.
The mission of Zyno Medical is to design and manufacture the most advanced infusion systems while applying a commitment to quality, simplicity, durability, connectivity and upgradability in order to deliver extraordinary benefits in patient safety, work flow efficiency and low total cost of ownership. For more information, please visit www.zynomed.com.