Menu Close

IHS Receives CE Mark Approval for EU Distribution

IHS Announces CE Mark Certification for Proprietary Intravenous and Subcutaneous Syringe Infusion System

July 22, 2021 09:00 AM Eastern Daylight Time

CHESTER, N.Y.–(BUSINESS WIRE)–Innovative Health Sciences, LLC (“IHS” or the “Company”) announced today that they have received ISO 13485 quality management system and CE mark certification for the Insignis™ Syringe Infusion System. The CE mark, abbreviated for European Conformity (“Conformité Européenne”), enables IHS to sell the system throughout the European Union.

“The Insignis™ system represents a paradigm shift in simplicity, excellence, cost effectiveness, usability, and patient-centered design”

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 transformative Insignis™ System for intravenous administration answers the world-wide 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 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,” says Andrew Sealfon, IHS founder, Chairman, and CTO.

Sealfon is a forty-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, Chairman of the Board, and Chief Executive Officer from September 1982 until his termination (July 25, 2018).

About Innovative Health Sciences

New York-based Innovative Health Sciences, LLC provides innovative solutions to the infusion healthcare market. IHS’ approach is patient-centric and future-oriented; our goal is to provide the highest quality of life by empowering the patient to take control of their infusion.

Forward-Looking Statements

The statements contained herein are not guaranteed of future performance and undue reliance should not be placed on them. Such Forward-Looking Statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied. These statements are based on management’s beliefs and theory. The Company undertakes no obligation to update Forward-Looking Statements if circumstances or management’s estimates or opinions should change, except as required by applicable securities laws.

Contacts

FMI: Tyler Kilcoin
845-610-5665
tkilcoin@innohealthsci.com