Founded 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.
FDA 510(k) submission
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ISO 13485
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21 CFR Part 820
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Innovative Health Sciences, LLCFounded 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.CHESTER, NY
Infusion DynamicsInfusion Dynamics manufactures the Power Infuser®, a portable electronic infusion pump designed for IV fluid and blood management. The device is small, durable, and easy to use for accident scenes, transport, and hospital settings.PLYMOUTH MEETING, PA
New Era Pump Systems, IncFounded in 1996 by Barry Cowen, New Era Pump Systems makes programmable syringe and peristaltic pumps for laboratory, production, microfluidics, and OEM fluid-control applications. Its pumps are designed and manufactured in the USA, with the company’s customer-focused approach extending from affordable standard equipment to custom mechanical, electronic, and firmware modifications. New Era also supports long-lived equipment, noting that it can often service pumps manufactured more than 25 years ago.FARMINGDALE, NY
B. Braun Medical IncFor more than four decades, B. Braun Medical Inc. has built its U.S. identity around patient safety and responsible medical manufacturing. Based in Bethlehem, Pennsylvania, it supplies healthcare providers with smart infusion therapy and related medical solutions, with a longstanding focus on reducing the use of potentially harmful materials in IV care.BETHLEHEM, PA