Innovative Health Sciences

Innovative Health Sciences (IHS) is a medical device company founded in 2019 by medical engineer Andy Sealfon, headquartered in Chester, New York. The company develops and commercializes the Insignis™ Syringe Infusion System, a non-electric, mechanical infusion pump designed for intravenous (IV) and subcutaneous medication delivery. The Insignis™ system represents a novel approach to infusion therapy, combining the accuracy and performance of electronic systems with mechanical simplicity, portability, and cost-effectiveness. Key product features include selectable rate flow control, low pressure delivery, high accuracy, and real-time patient titration capability for subcutaneous applications. The platform addresses market gaps by providing portable, user-friendly alternatives to expensive and complex electronic infusion pumps, particularly for patients requiring long-term IV replacement therapy or antibiotic administration. IHS markets its products to patients, pharmacies, clinicians, and distributors. The company has received FDA 510(k) clearance for its Insignis™ Subcutaneous Needle Sets and Insignis™ Syringe Infusion System. Most recently, IHS secured CE Mark approval through BSI (Notified Body) for Medical Device Regulations (MDR) Quality Management System certification, enabling worldwide distribution. The company's product portfolio includes the Insignis Infusion Pump, IV Controller, OneSett Subcutaneous Administration Set, Fixed Rate Tubing for IV and subcutaneous use, and Subcutaneous Needle Sets. Manufacturing and quality systems meet international regulatory standards for medical devices.