Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories.
The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical services and hospitals.
The compact Sapphire infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural medication, epidural medication, blood and blood products. It has a color touch screen for intuitive and fast operation, built-in safety mechanisms and technology designed to minimize dosage errors and false alarms.
The most recent hardware and software upgrade adds a number of improvements, including:
- A perineural route intended to support a wider range of pain management therapies.
- A software update to simplify workflows by reducing key presses and message prompts, and enhancing preset programs.
- Updated epidural portfolio with NRFit dedicated connectors
- Improved maintenance PC suite functionality.
“For over a decade, the Sapphire infusion pump has established itself as an extremely capable and easy to use across the healthcare continuum,” said Eitan Medical CCO of medication delivery solutions Roger Massengale in a news release. “This clearance is an example of our continued dedication to innovation making our pumps easier to use for providers and safer for patients.”