Zyno Medical, LLC today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nimbus II ambulatory infusion system. The device is intended for subcutaneous, percutaneous, perineural, epidural and intravenous infusion, including but not limited to patient-controlled analgesia (PCA) delivery. It has been approved to be used in clinical and non-clinical environments such as homes.
The Nimbus II Ambulatory Infusion System extends the infusion pump life compared to the original generation system. Now with changeable batteries, the Nimbus II can deliver longer infusion times and higher infusion volumes. This device relies on a simple, easy-to-use interface, and reliable technology to create accurate electronic delivery of fluids through continuous mode and/or PCA mode. The compact size, high reliability, and low cost of the Nimbus II are well suited for many different healthcare settings such as the hospital, home care, and alternate care environments.
"We are very excited to launch our next generation ambulatory infusion technology,” said Dr. Chaoyoung Lee, president, and owner of Zyno Medical, LLC. “The Nimbus II expands the product line with a system for therapies that require longer, higher volume infusions and creates a platform that will allow us to expand into a wide range of care settings.”
Zyno Medical, LLC plans to launch Nimbus II with deployments to select healthcare facilities beginning in the fall of 2016.
About Zyno Medical, LLC
Zyno Medical’s market focus is the non-acute or alternate care market where it manufactures durable, advanced technology infusion pumps designed specifically for needs that are unique to this market. Since its inception, the company has assembled a wealth of engineering talent and clinical experience, as well as manufacturing, customer and market expertise. Zyno Medical is headquartered 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 for patient safety, workflow efficiency and low total cost of ownership. For more information, please visit www.zynomed.com.
