How CathWorks Leaned on Its Partner Medtronic to Succeed

Why It Matters

The deal fast‑tracks adoption of AI‑based coronary diagnostics, reducing invasive procedures and expanding Medtronic’s digital health footprint.

Key Takeaways

• Medtronic to acquire CathWorks for up to $585 M
• AI FFRangio now processes scans in two minutes
• System achieved FDA, EU, Japan approvals
• Partnership generated five global validation studies
• Large RCT of 1,900 patients slated for ACC

Pulse Analysis

The coronary artery disease market has long relied on invasive fractional flow reserve (FFR) measurements, a process that adds time, cost, and patient risk. Recent advances in artificial intelligence and computational modeling now enable clinicians to extract physiological data from standard angiograms, promising a shift toward faster, less invasive diagnostics. This transition aligns with broader healthcare trends favoring value‑based care and digital integration, positioning AI‑enabled tools as a strategic priority for device manufacturers seeking to differentiate their cath‑lab offerings.

CathWorks exemplifies how a focused partnership can accelerate such innovation. After an initial launch faltered due to manual 3‑D modeling, Medtronic’s senior executives provided market insight that spurred a redesign using neural networks to automate vessel identification and resistance calculations. The revamped FFRangio system now delivers results in two minutes with 95% automation, earning regulatory clearance across the U.S., Europe, and Japan. Five validation studies and a forthcoming 1,900‑patient randomized trial underscore the technology’s clinical credibility and readiness for broader adoption.

Medtronic’s $585 million acquisition signals a decisive move to embed AI diagnostics into its coronary portfolio, reinforcing its position in the rapidly evolving digital health space. By integrating CathWorks’ software, Medtronic can offer a seamless, data‑driven workflow that reduces reliance on wire‑based FFR, potentially lowering procedure costs and improving patient outcomes. The partnership also illustrates a model where early strategic investment, rather than outright acquisition, allows a startup to mature its product before scaling globally, a playbook other med‑tech firms may emulate as they chase similar AI‑centric growth opportunities.

How CathWorks leaned on its partner Medtronic to succeed

By Skyler Rivera · February 17 2026

When it came to its mission to disrupt how heart disease is treated, CathWorks’ partnership with Medtronic was about more than an acquisition. Its CEO explains.

Can a computer software take routine angiogram X‑rays and evaluate coronary artery disease without invasive pressure wires?

The idea sounded “crazy” to the founders of CathWorks in 2013, but the possibility ignited the startup’s bold mission to transform how heart disease is diagnosed and treated.

CathWorks CEO Ramin Mousavi fast‑tracked the company’s path to acquisition by relying on its strategic partnerships.

Like many startups, CathWorks initially struggled. During the COVID‑19 pandemic, the company almost evaporated. It survived by leaning on strategic partnerships, and 13 years after CathWorks’ founding, Medtronic announced plans early this month to acquire the company for up to $585 million in a deal expected to close near the end of April.

Medtronic saw potential in CathWorks’ technology in 2018, becoming a minority investor with non‑diluted funding before it was commercialized.

“[It was] the best of both worlds,” said CathWorks CEO Ramin Mousavi during an appearance on the DeviceTalks Weekly podcast. “The money invested in CathWorks empowered us to put our heads down and innovate, and generate clinical evidence.”

Medtronic now sees the potential for CathWorks to positively disrupt the traditional wire‑based FFR segment, according to Jason Weidman, SVP and President of Medtronic’s Coronary & Renal Denervation business, and a key voice in CathWorks’ product development.

Weidman said in a Feb. 3 news release: “This acquisition allows Medtronic to transform the cath lab with a technology that provides real‑time data, informs individualized treatment approaches and drives new standards of care.”

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Birth of a startup

Coronary artery disease (CAD) is a leading cause of death in the United States. When a patient shows suspected CAD symptoms, they may undergo two diagnostic procedures: an angiogram and a fractional flow reserve (FFR) test.

During an angiogram, contrast dye is injected through a catheter in the femoral artery, illuminating blood flow and helping visualize blockages and narrow arteries on X‑ray images. If stenosis is severe or inconclusive, a more invasive procedure to assess FFR would determine the type of intervention needed.

FFR measures the severity of stenosis and potential for ischemia, using sensors on a guidewire to measure blood flow on either side of the blockage. Sometimes, physicians increase blood flow with medication for the most accurate measurements. Wire‑based FFR is underutilized because of its invasive nature despite being essential for improving patient outcomes.

So, CathWorks sought to create an alternative, non‑invasive system.

“The unmet need was, ‘Can you find an innovative technology solution that can fit within the current workflow, that can be a better alternative?’ [We needed] one that was well vetted and clinically evaluated for invasive coronary physiology assessment.” – Mousavi

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CathWork’s first launch and failure

CathWorks’ FFRangio system works as an intra‑operative device that uses artificial intelligence (AI) and advanced computational technology to provide a comprehensive physiological assessment of the entire coronary tree based on routine coronary angiograms (X‑rays) within minutes. But the system wasn’t always a quick success.

FFRangio’s first rendition showed high diagnostic accuracy when compared to traditional wire‑based FFR when it earned FDA approval in 2018; however, it did not include the advanced technology that creates today’s coronary assessment.

Instead, all arteries were manually selected and hand‑drawn (or traced) based on three X‑rays to create a full 3‑D coronary‑tree model suitable for diagnosis.

“No way [physicians] were going to spend 22 minutes in the lab letting someone do a Picasso,” Mousavi said. “Like most startups, [we] failed very badly at that launch … we had to go back to the drawing board.”

Mousavi consulted with Weidman and Chris Eso, both top executives in Medtronic’s coronary portfolio, asking, “How are we going to solve this?” The problem was twofold: CathWorks’ technology failed to satisfy customers, and it needed a solution to accelerate its diagnostic process. Even if a quick fix were found, the COVID‑19 pandemic would hinder any chance at a successful product launch.

“The company came very close to not existing,” Mousavi said.

Eso and Weidman were willing to take a risk with the failing technology. They gave CathWorks feedback based on industry experience and sought insights directly from customers. Partners recommended automating the diagnostic process—specifically, the manual model‑creation element—using AI and advanced computational science. Mousavi’s engineers then embarked on a revision of FFRangio.

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Continued development & how it works

Mousavi’s team first began automating the manual 3‑D coronary model process by constructing artificial neural networks with X‑ray images as data sets.

FFRangio now takes three X‑ray images and uses a series of neural networks to organize and identify the main vessels and side branches in the artery. Then, it uses a proprietary algorithm validated by a resistance model to build the 3‑D coronary‑tree model.

After automating the 3‑D model process, CathWorks treated the heart as an “electric circuit,” Mousavi explained:

“We take all the [heart’s] nodes and calculate how much resistance is in each of the nodes. Then, we convert that into a visualization of the blockage … it’s pretty genius actually.”

Mousavi and his team added additional tools for physicians to virtually size patients for interventions and predict the clinical impact if the blockage was treated. FFRangio’s marquee feature simulates a pull‑back curve to determine FFR values, helping patients avoid unnecessary percutaneous coronary intervention (PCI).

CathWorks’ revamped system is around 95 % automated with some user confirmation—what once took 22 minutes now takes only two minutes.

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Launch 2.0 and a renewed partnership

CathWorks and its partners tested the upgraded FFRangio system in a limited release aimed at gaining customer feedback. The result was a success.

“[Our partners] saw the same thing that we saw,” said Mousavi. “The improvement that we were all hoping for.”

Following this success, CathWorks began receiving acquisition offers, but Mousavi made a “conscious decision” to enter another strategic partnership with Medtronic in 2022. He said the company was still in its early commercial days despite the vast improvement, and he didn’t want the technology to fail after acquisition.

“One of the most common things that happens to great technologies when they get acquired by larger companies is that there’s a period of, ‘Oh, there [are] other things wrong with the product, they still have to fix it.’ There’s no established process for [that] business model. There’s a lot of disruption … you lose the people, things fall apart, and the technology never fulfills its true promise because it wasn’t quite ready for the vision that investors had.” – Mousavi

The 2022 partnership structure gave Mousavi and his team time to bring the technology to a point where it had a higher chance of becoming the next standard of care. They needed more clinical evidence and access to Medtronic’s global network in a co‑promotion deal while CathWorks engineers continued to advance the software.

Since beginning its partnership with Medtronic, CathWorks has conducted five validation studies with global clinical data, and FFRangio has earned regulatory approval in the U.S., Europe, and Japan. The company will present results of its largest randomized controlled clinical trial—over 1,900 patients across 59 global investigational sites—at the American College of Cardiology meeting later this year.

“We’ve done a lot of things that you couldn’t do if you just handed [the technology] to someone else. That’s why we chose Medtronic.” – Mousavi

DeviceTalks Editorial Director Tom Salemi contributed to this report.