Founded in 2019 by medical engineer and inventor Andrew Sealfon, Innovative Health Sciences develops and commercializes non-electric syringe infusion systems for intravenous and subcutaneous medication delivery. Based in Chester, New York, the company’s Insignis system combines a mechanical 13.5-psi syringe driver with selectable flow-rate control, giving patients and clinicians a portable alternative to electronic infusion equipment. The system is FDA cleared, CE Mark approved, and supported by MDSAP and ISO 13485 certifications.
ISO 13485 Quality Management System
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CE Mark Certification
certification
CE MDR QMS Certificate
certification
MDSAP Certification
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FDA Clearance
certification
Enable InjectionsFounded in 2010, Cincinnati-based Enable Injections develops and manufactures enFuse, a hands-free wearable drug-delivery platform that administers large-volume medications under the skin rather than intravenously. The company combines in-house design, development, and GMP-compliant manufacturing with a patient-centered approach, and its technology now supports the FDA-approved EMPAVELI Injector and other partner-branded delivery systems.CINCINNATI, OH
AmgisFounded in 2020 by infusion-pump veterans Jason Maine and Roger Hungerford, Amgis is a privately funded, engineer-led company focused on rethinking electronic IV therapy. After five years and $25 million in self-funded research and development, the company is preparing its first infusion system for FDA review, with the goal of addressing longstanding flow-measurement problems for clinicians and patients.MEDINA, NY
Congruence Medical Solutions LLCBaltimore-based Congruence Medical Solutions designs, develops and supplies drug-delivery devices that add precision and usability to standard prefillable syringes and other primary containers. The company is especially known for its award-winning Microliter Dosing Syringe, developed for difficult small-volume injections and recognized with the 2019 PDA Drug Delivery Innovation Award in partnership with Santen Pharmaceutical. Its platforms also address viscous and variable-dose therapies, home injection, and drug waste from vials, including through the ELDO™ technology selected for the Johnson & Johnson Innovation–JLABS and BARDA BLUE KNIGHT program.BALTIMORE, MD
CathCareCathCare makes PortPouch®, a wearable IV catheter cover designed to protect insertion sites while reducing infection risk and accidental dislodgement. Based in Southampton, New York, the company focuses on patient-centered medical products that make IV treatment more comfortable and manageable in hospitals and at home, including for children and other vulnerable patients. CathCare is registered with the FDA and certified by the Women’s Business Enterprise National Council.SOUTHAMPTON, NY