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