CE Mark Granted for Proprietary Syringe Infusion System

Innovative Health Sciences LLC has received ISO 13485 quality management system and CE mark certification for the Insignis Syringe Infusion System. The CE mark, abbreviated for European Conformity (“Conformité Européene”), enables IHS to sell the system throughout the European Union.
 
The Insignis Syringe Infusion System is the first combination of intravenous and subcutaneous non-electric infusion pump created for use with a selectable rate flow controller, the IV Controller and the OneSett.
 
The Insignis System for intravenous administration answers the worldwide need for a portable, non-electric, versatile, cost-effective, and intuitive infusion pump to accurately deliver medications from KVO up to 250ml/hr with a direct reading selectable rate flow controller.
 
For subcutaneous applications, the OneSett consists of a selectable rate flow controller attached directly to a subcutaneous needle set (1-4 leg configuration offering), which enables the user to select the flow rate (from 10ml – 60ml) with the turn of a dial. The flow rate indicated on the dial is delivered to each needle site—no calculation is required.
 
The Insignis syringe pump is much less costly, offered at 139 Euro, and when considering the cost of the separate pieces of the ancillary supplies (needle sets, flow control tubings, and flow controller), the OneSett is also lower cost per infusion—even before considering the savings incurred from fewer stocking parts.
 
The IHS infusion system addresses nearly every infusion therapy need and can support intermittent, “pause” dosing, ideal for lengthy low-volume hospital infusions. “The IHS system represents a paradigm shift in simplicity, excellence, cost effectiveness, usability and patient-centered design,” said Andrew Sealfon, IHS founder, chairman, and chief technology officer.
 
Sealfon is a 40-year investor, innovator, and executive of the medical device industry. Inventor and founder of Repro-Med Systems Inc. (KORU Medical Systems), Sealfon served as its president, board chairman, and CEO from September 1982 until his termination (July 25, 2018).
 
New York-based Innovative Health Sciences LLC provides innovative solutions to the infusion healthcare market. IHS’ approach is patient-centric and future-oriented; its goal is to provide the highest quality of life by empowering the patient to take control of their infusion.