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 News Release - January 19, 2021

Eitan Medical Receives FDA Clearance for Upgraded Sapphire(TM) Infusion Pump System

Upgraded Rev15 Sapphire™ Infusion System Provides Advanced Performance and Customization Capabilities Within Hospital, Pre-Hospital and Ambulatory Environments

NETANYA, Israel, Jan. 19, 2021 -- (Healthcare Sales & Marketing Network) -- Eitan Medical, a global leader in advanced infusion therapy and drug delivery solutions across the care continuum, announced today that its upgraded Sapphire™ infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories, has received US Food and Drug Administration (FDA) 510(k) clearance. 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 (EMS) and hospitals.

The compaCT and robust Sapphire™ infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood, and blood produCTs, making it suited for complex and demanding medical scenarios. The pump's smart technology includes a unique full color touch screen for intuitive and fast operation, built in safety mechanisms aimed to enhance patient safety, and advanced technology that helps minimize dosage errors and false alarms.

The most recent hardware and software upgrade adds a number of key improvements, utilizing the Sapphire™ family's future-ready features. The new device features include:
  • Perineural route was added to the Sapphire™ intended use to support a wider range of pain management therapies
  • 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:
  • - FasTest PM - an on-site preventative maintenance solution designed to increase efficiency. FasTest PM enables quick and intuitive pump certification testing, supported with a downloadable manufaCTurer certificate. FasTest PM is capable of testing 8 pumps simultaneously with an average pump testing time of 5 minutes, streamlining annual maintenance and testing between patients.
  • - Sapphire™ Configuration Manager – Sapphire is a fully customizable infusion device, that can be configured to the different clinical use. Sapphire™ Configuration Manager is a tool that allows for faster, simpler, and reliable configuration management across a fleet of pumps. Sapphire™ Configuration Manager enables users to export, save, share, and load configurable settings, drug libraries and preset programs. Promoting standardization by simplifying the creation of presets programs and configuration settings while significantly reducing resources required to manage these critical tasks.
"At Eitan Medical, we develop innovative and reliable technologies to provide a world-class user and patient experience via our drug delivery and advanced infusion solutions," said Roger Massengale, CCO of Medication Delivery Solutions at Eitan Medical. "For over a decade, the Sapphire™ infusion pump has established itself as an extremely capable and easy to use across the healthcare continuum. This clearance is an example of our continued dedication to innovation making our pumps easier to use for providers and safer for patients."

About Eitan Medical

Eitan Medical is reimagining drug delivery, with reliable innovations that put patients at the center of care, making drug delivery easier and safer than ever before. Patient safety and care is only the starting point, as Eitan Medical goes beyond - delivering conneCTed, intuitive drug delivery and infusion solutions that are designed to improve patient and clinician quality of life across the continuum of care, including hospital, ambulatory, and home care environments. For over a decade, Eitan Medical has provided safe, intuitive, and flexible solutions that meet evolving drug delivery needs. Eitan Medical's produCT lines include the Sapphire™ infusion platform**, providing conneCTed infusion therapy systems in hospital and ambulatory settings; the Sorrel™ wearable drug delivery platform***, the patient-centric on-body injeCTor for delivery of biologic treatments; and Avoset™****, conneCTed infusion systems for the home care market.

* NRFit® is a trademark of B. Braun

** Q Core Medical Ltd is legal manufaCTurer of the Sapphire™ infusion pump

*** Sorrel Medical Ltd is legal manufaCTurer of the Sorrel™ wearable drug delivery platform (FDA investigational device)

**** The Avoset™ devices are under development

Eitan Medical, Sapphire, Avoset, and Sorrel are trademarks or registered trademarks of Eitan Medical.


Source: Eitan Medical

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