Eitan Medical’s Sapphire infusion pump recall is Class I

The Sapphire multi-therapy infusion pump. [Image from Eitan Medical]The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind.

Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, 2023, and it affected 1,383 devices in the U.S.

According to an FDA notice, the company recalled the pumps due to software issues with version Rev 16.10. Pumps with this software version may fail to detect air in the line when running on battery power. In some cases, the pump may not sound an alarm when air enters the line.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Eitan Medical appoints new CFO

Shaul Sharoni. [Image from LinkedIn]Drug delivery technology developer Eitan Medical announced today that it appointed Shaul Sharoni as its new chief financial officer.

Sharoni brings more than 20 years of experience in financial management to the Netanya, Israel-based company. As CFO, his duties include overseeing all financial operations. That includes strategic financial planning, budgeting, forecasting and financial reporting.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Eitan Medical launches cloud-based infusion management platform

Drug delivery technology developer Eitan Medical announced today that it launched the Eitan Insights cloud-based infusion management system.

Netanya, Israel-based Eitan Medical designed Eitan Insights to meet the unique needs of at-home and specialty infusions. The company’s infusion systems, Sapphire, and Avoset, connect and transmit infusion data to the platform. Sapphire now features a plug-and-play cellular accessory, Sapphire Connect, while Avoset has the AvosetGo app accompanying it.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Eitan Medical opens new manufacturing facility for wearable drug delivery platform

The Sorrel wearable drug delivery platform. [Image from the Eitan Medical website]Eitan Medical announced today that it opened a new manufacturing facility at its headquarters to support drug delivery device production.

Netanya, Israel-based Eitan intends for the facility to manufacture its Sorrel wearable drug delivery platform. That includes multiple device configurations, such as vial- and cartridge-based wearable injectors. On-site manufacturing supports Eitan’s production scale for its pharmaceutical solutions division.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Taking the extra steps to ensure medical device quality assurance

Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.

Judith Antler, Eitan Medical

[Image from Unsplash]

Quality assurance (QA) control is a central component of any manufacturing process, ensuring the end product is reliable, safe and of the highest quality. This process is critical in the medical device industry, as faulty devices can have severe patient health implications.

When we consider the current COVID-19 pandemic and the abundance of critical care administered via medical devices, today more than ever, we must aim to ensure our products meet all safety standards and beyond.

Unfortunately, even with the current regulatory policies and systems, there are still recalls and field actions in the medical device industry. Both humans and machines are subject to error, but we must…

Read more
  • 0

Eitan Medical wins EU clearance for Sapphire infusion pump

Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump.

Approval for the Sapphire infusion pump, along with its accessories and administration sets, was granted in January 2021, according to a news release. The certification is EU MDR 2017/45.

Get the full story at our sister site, Drug Delivery Business News.

Read more
  • 0

Eitan Medical lands FDA clearance for infusion pump system upgrade

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 …
Read more
  • 0