CDX Medical Technologies Secures $2.5M To Advance Smart ECMO Platform Toward FDA Approval

CDX is eying applications for its pump platform that go beyond ECMO. The company's CEO says smart pumps that can be fine-tuned to patient volume and configuration are needed, and CDX is creating a scalable solution capable of supporting both acute and chronic lung care.

Over the next 12 to 18 months, CDX aims to achieve two major milestones: Working with the FDA to obtain approval for its ECMO pump and collaborating with lead clinical sites to initiate first-in-human use. Picture Courtesy: Shutterstock

As large medtech incumbents maintain dominance in high-resource extracorporeal membrane oxygenation (ECMO) environments, a quieter race is emerging to decentralize the therapy for broader use. CDX Medical Technologies, now backed by $2.5 million in Series A funding and fresh board leadership, believes its compact, AI-enhanced system offers the first real pathway to achieve this. With automation, modular design, and a resource-efficient footprint, CDX could make ECMO viable in places it's never been before – from peripheral ICUs to transport units.

The investment, led by Joe Kiani, founder of Masimo, Willow Laboratories, and Like Minded Labs, will help in CDX's push toward regulatory approval and commercialization.

Kiani, a globally recognized figure in health technology innovation, has joined the CDX board of directors. The funding round he has led will support completion of regulatory testing, advance market approval processes, and help initiate early-stage commercialization of CDX's ECMO system.

Strategic Investment To Drive Regulatory And Commercial Roadmap

CDX Co-CEO Gopal Chopra described the immediate focus of the Series A capital as enabling the company to complete its regulatory road map and prepare the system for clinical use. "Bench and in vivo testing, as well as platform design with clinical sites," are top priorities, Chopra said in an interview with Medtech Insight.

Over the next 12 to 18 months, CDX aims to achieve two major milestones: Working with the US Food and Drug Administration to obtain approval for its ECMO pump and collaborating with lead clinical sites to initiate first-in-human use.

Chopra said, "Joe brings a wealth of experience and insight into the world of respiratory care and intelligent medical devices. His investment and contributions at the board level will significantly assist the company in creating a new market and disrupting respiratory care to the benefit of patients worldwide. Joe's enthusiasm for impactful innovation and his commitment to patient safety and care will be transformative."

"Joe's involvement brings the expertise to navigate the global landscape of medical devices and strategic insight into growing markets," added co-CEO Rick Smith.

Kiani, in a statement, said: "ECMO is a lifesaving solution, but today it takes too much from our valued resources and therefore it's only provided to a few. CDX is revolutionizing ECMO by making it not just small and portable, but also by practically automating it. The CDX platform will benefit respiratory failure patients worldwide in an area that has needed disruption."

Compact, Smart, And Practically Automated

At the core of CDX's innovation is a redesigned ECMO pump that aims to significantly reduce complexity and resource requirements. When asked what sets CDX's pump apart from existing technologies, Chopra responded simply: "Compact and smart."

The company describes the platform as "practically automating ECMO," which Chopra elaborated means creating ease of workflow in setting up, priming, and engaging the pump with a "least burden[some] approach." This automation could reduce clinician workload and streamline a procedure currently requiring extensive technical expertise and monitoring.

Hugh Cassiere, director of critical care, cardiac services at Northwell Health's South Shore University Hospital in Bayshore, NY, and current chair of the FDA's Anesthesiology and Respiratory Therapy Devices panel, supported the platform's potential. "CDX is providing a much-needed innovation where nothing exists. The company has demonstrated its commitment to innovation and incorporating the clinical need, and we are very excited to be a lead potential site for the commercial release," he said.

Competitive Advantage

Competitors in the ECMO arena include both large medtech companies and specialized device innovators such as Getinge, Medtronic, Abiomed, Xenios AG, and Hemovent, each of which brings established capabilities to the field.

Getinge, with its Cardiohelp and Rotaflow II ECMO systems, is a global leader in ECMO devices. These systems are robust and widely used in hospitals, but are large, require significant training, and are labor-intensive.

Medtronic also competes in this space with products like the Affinity centrifugal pumps and oxygenators, though it does not offer a fully integrated ECMO system. Its solutions, which are deeply integrated into hospital environments and cardiac surgery workflows, are typically used in combination with other devices and lack the automation and portability that CDX is prioritizing.

Abiomed, now part of Johnson & Johnson, focuses on cardiac support with devices like the Impella series. These pumps are used for circulatory support rather than oxygenation, meaning they do not compete directly in ECMO but serve overlapping critical care use cases.

Xenios AG, a subsidiary of Fresenius Medical Care, markets the Novalung and i-cor systems in Europe. These devices support lung and heart-lung functions and are more compact than older ECMO systems. However, they still require significant hands-on management by clinicians and do not incorporate the level of smart automation that CDX is developing.

Hemovent, recently acquired by MicroPort, is one of the few companies developing portable ECMO systems, such as the MOBYBOX. While Hemovent shares CDX's interest in portability, its devices are primarily targeted for short-term emergency use and lack AI-driven automation or a modular platform approach.

What sets CDX apart across the competitive landscape is its unique combination of features: compact and portable design, automated workflows to reduce clinical workload, and a smart platform architecture that can scale from acute to chronic respiratory care. The system is designed to make ECMO not only easier to deploy and manage in intensive care units but also more accessible in peripheral care settings like transport units, nursing facilities, and hospitals without full cardiopulmonary support infrastructure.

A Platform For Broader Respiratory Care

While the current focus is ECMO, CDX sees broader applications for its pump platform. Chopra explained that "smart pumps that can be fine-tuned to volume and configuration do not exist, and one size does not fit all." He added that CDX has "redesigned this approach," aiming to provide scalable respiratory support beyond traditional ECMO settings.

The company is building a solution for both acute and chronic lung care, which could open up new use cases across a variety of clinical environments.

Strong Clinical Engagement And Feedback

During the bench and in vivo testing phases, CDX has worked closely with hospitals and clinicians and has drawn positive feedback, with some in the field even suggesting that the innovation could have the same transformative impact on respiratory failure as early cardiac stents had on managing ischemia.

The company has taken what it describes as a "methodical approach" in preparation for regulatory submission and has maintained "collaborative guidance" in its engagement with the FDA, Chopra said. He added that it is not currently pursuing accelerated pathways such as breakthrough device designation, but may in the future.

Enabling Access In Resource-Limited Settings

Global accessibility is another priority. While ECMO's resource intensity currently limits its use to large hospitals, CDX's compact and power-efficient design eyes to change that. "Powering and compactness are critical components to make this more accessible to the world," Chopra said.

This could make ECMO available in settings such as peripheral intensive care units, transport environments, and potentially even emergency or field situations.

Commercialization Plans And Clinical Partners

Chopra said the company's first commercial rollouts would target "respiratory ICUs" and that the company is already in early discussions about expanding use cases both clinically and in terms of care settings.

South Shore University Hospital will play a key role in this process. "North Shore is where we have key advisers and working with their system to better understand the expanded indications, and managing peripheral ICUs is the initial focus," Chopra explained.

In parallel, CDX is also exploring collaborations with OEMs, digital health platforms, and payers to scale adoption of the system. These partnerships could support integration into broader care pathways and payer frameworks as the company moves toward commercialization.

Bottlenecks And Opportunities In The ECMO Market

Chopra described current protocols in the wider ECMO market as being "still in their infancy." He said that organizations such as the Extracorporeal Life Support Organization (ELSO) have seen limited innovation in the past decade, creating an unmet need for new solutions.

"Protocols are still in their infancy and organizations like ELSO have little innovation arriving to provide better therapy options to a larger spectrum of patients," Chopra said.