The Future of IV Therapy Starts Here

Past To Present

Since the 1950s, IV infusion has followed the same flawed playbook — until now. Amgis introduces vDFM, volumetric Direct Flow Measurement: a breakthrough sixth standard of care that replaces outdated, failure-prone systems with precision, safety, and simplicity.

Unlike traditional devices that rely on indirect flow measurement, vDFM eliminates undetected flow errors, nuisance alarms, and pressure-related complications. It simplifies setup, supports longer use with fewer supplies, and helps clinicians work confidently without second-guessing their equipment.

It’s time to redefine infusion with smarter technology, better outcomes, and a safer path forward — and we’re making it happen.

Volumetric Direct Flow Measurement

Watching intravenous delivery when you can’t.

Precision Measurment of Every Drop.

Present to Future

Amgis was founded to do what decades of industry evolution failed to: make electronic IV therapy truly safe.

Established in 2020 by Jason Maine and Roger Hungerford, Amgis is a privately funded, engineer-led company dedicated to solving the root causes of IV delivery failures, not just patching them. With decades of infusion pump experience and a history of successful exits, our founders set out to replace the outdated standard of volumetric Indirect Flow Measurement with something entirely new: vDFM, volumetric Direct Flow Measurement.

Five years and $25 million in self-funded R&D later, Amgis is preparing a 20,000-page 510(k) submission for FDA Fast Track review, with clearance anticipated in late 2026. Every aspect of the company — from design and manufacturing to regulatory and support — is built in-house to ensure precision, control, and trust.

The bottom line? We’re not here to compete with legacy systems. We’re here to replace them.

Who’s Who

Jason Maine

President and Director of Research & Development

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Responsibilities

Leading the development of innovative technology to deliver the best possible patient outcomes, while building and empowering a high-performing team to bring that vision to life.

Bio

I co-founded AMGIS with Roger Hungerford after serving in senior leadership roles in Engineering and Operations at leading infusion pump manufacturers SIGMA LLC and Baxter International Inc. These experiences gave me deep insight into the healthcare technology landscape—how the industry operates, where fundamental flaws exist in current approaches, and how to inspire teams to deliver exceptional results. Drawing on this foundation, AMGIS is re-envisioning infusion therapy from the ground up, delivering superior technology designed for better patient care.

Tresia O’Shea

Director of Quality Assurance & Regulatory Affairs

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Responsibilities

Tresia leads the company’s global regulatory strategy and oversees all submissions to FDA, Health Canada, and notified bodies under the EU MDR. She is also responsible for developing, maintaining, and continuously improving the AMGIS Quality Management System (QMS) to meet ISO 13485 and 21 CFR Part 820 requirements.

Bio

Tresia brings deep experience in Regulatory Affairs and Quality Assurance, having held roles at both large and early-stage medical device companies. She is committed to ensuring that quality and compliance are built into every stage of the product lifecycle—from development through manufacturing and post-market support. Her passion lies in driving operational excellence and delivering products that improve patient care and safety.

Our Path to the Sixth Standard

Pre –

1958

IV therapy begins with gravity

Early IV systems relied on manual drip rates and gravity pressure, unreliable for anything beyond basic hydration or blood transfusion.

1958

Electronic infusion pumps debut

Positive pressure pumps introduce more consistent flow, but lack alarms or safety controls. This marks the second standard of care.

1969

nonvolumetric Direct Flow Measurement (nvDFM) gravity pressure controllers

Standard gravity IV set using drops/minute, gravity pressure controllers and positive pressure pumps. IVAC’s drop counting sensors, mounted on IV set drip chambers, counted drops/minute and adjusted device mechanisms to make flow go faster or slower. Those drop sensors also created the first infusion pump alarm system.

1972

vIFM becomes the norm

Volumetric Indirect Flow Measurement (vIFM) is introduced, forming the foundation for nearly all infusion pumps still in use today — despite critical flaws like missed alarms, undetected flow errors, and pressure-related complications.

2003

“Smart” pumps emerge

Software-enabled pumps bring drug libraries and alerts, but still rely on vIFM, inheriting its fundamental risks.

2020

Amgis is founded

Frustrated by decades of stagnation in the field, industry veterans Jason Maine and Roger Hungerford launch Amgis to eliminate vIFM’s systemic failures.

2021 –

2024

From concept to breakthrough

Amgis develops and validates vDFM (volumetric Direct Flow Measurement), the first control system capable of seeing, measuring, and correcting flow in real time.

2025

FDA submission

Amgis prepares its 510(k) application for FDA Fast Track review, aiming to introduce the sixth standard of care in IV therapy.

Expected –

2026

New standard, fully realized

Upon clearance, Amgis will launch the industry’s first infusion system built from the ground up to prioritize safety, simplicity, and clinical confidence.