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Eitan Medical

Eitan Medical’s Sapphire infusion pump recall is Class I

December 1, 2023 By Sean Whooley

Eitan Medical Sapphire Multi-Therapy infusion pump

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, […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Technology Tagged With: Eitan Medical, FDA

Eitan Medical appoints new CFO

July 18, 2023 By Sean Whooley

Shaul Sharoni LinkedIn CFO Eitan Medical

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. According […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Personnel Tagged With: Eitan Medical, Personnel Moves

Eitan Medical launches cloud-based infusion management platform

July 12, 2023 By Sean Whooley

Eitan Medical Eitan Insights

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Technology Tagged With: Eitan Medical

Eitan Medical opens new manufacturing facility for wearable drug delivery platform

January 17, 2023 By Sean Whooley

Eitan Medical Sorrel wearable drug delivery system

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 […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Technology Tagged With: Eitan Medical

Eitan Medical wins EU clearance for Sapphire infusion pump

March 10, 2021 By Sean Whooley

Eitan Medical

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. Sapphire includes upgraded Rev15 software, also EU MDR […]

Filed Under: Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Eitan Medical

Eitan Medical lands FDA clearance for infusion pump system upgrade

January 19, 2021 By Nancy Crotti

Eitan Medical

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 […]

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

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