• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Eitan Medical lands FDA clearance for infusion pump system upgrade

January 19, 2021 By Nancy Crotti

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.”

 

Filed Under: Featured, Food & Drug Administration (FDA) Tagged With: Eitan Medical, FDA

IN CASE YOU MISSED IT

  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance
  • Rapid Dose closes first tranche of $5M financing

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS