Innovative Health Sciences announced today that it received CE mark approval in Europe for its Insignis syringe infusion system.
Chester, N.Y.–based Innovative Health Sciences designed the Insignis syringe infusion system to offer a combination of intravenous and subcutaneous non-electric infusion with a selectable rate flow controller — the IV Controller and the OneSett.
According to a news release, the newly CE-marked system — which also garnered ISO 13485 quality management system certification — is the first combination of such infusion methods.
Insignis, used for intravenous administration, creates a portable, non-electric, versatile, cost-effective and intuitive infusion pump option, Innovative Health Sciences said. The system accurately delivers medications from KVO up to 250mL/hour with a direct reading selectable rate flow controller.
The company said Insignis will be offered at €139 (approximately $163.91), with the OneSett offering a lower cost per infusion, considering the cost of separate pieces of the ancillary supplies.
“The IHS system represents a paradigm shift in simplicity, excellence, cost-effectiveness, usability and patient-centered design,” Innovative Health Sciences founder, chairman & CTO Andrew Sealfon said in the release.