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At Cook Research Incorporated (CRI), being “first” isn’t about recognition—it’s about improving how quickly safe, effective medical devices reach patients.

In 2025, CRI became the first U.S.-based company to earn certification to ISO 14155, an international standard that defines how clinical studies on medical devices should be designed, conducted, and reported. The standard focuses on protecting patients, ensuring high-quality data, and maintaining ethical research practices.

For CRI, pursuing this certification was a natural extension of its role supporting Cook Medical. The global Clinical Affairs team designs and runs clinical studies that help demonstrate whether new medical devices are safe and effective—an essential step before those devices can be approved for patient use.

Why this certification matters

Medical device companies can conduct clinical studies without ISO 14155 certification, as long as they follow applicable regulations. However, certification provides independent verification that those studies meet globally recognized best practices.

“Regulators want to know they can trust the data they’re reviewing,” said Josh Hawkins, who served as CRI’s Quality Assurance director during the certification process. “This certification shows that our processes—from how studies are designed to how data is collected and analyzed—meet a very high standard.”

That confidence can help streamline interactions with regulatory agencies like the U.S. Food and Drug Administration, ultimately supporting more efficient pathways to approval.

What it takes to earn ISO 14155 certification

The certification process is rigorous and comprehensive.

ISO 14155 covers every aspect of a clinical study involving human participants, including:

How studies are planned and approved
How research sites and participants are selected
How data is collected, monitored, and verified
How results are analyzed and reported
How patient safety and ethical standards are maintained

To achieve certification, CRI worked with TÜV SÜD, an independent organization that audits companies against international standards.

The effort took about six months of preparation, followed by both remote and in-person audits before certification was awarded. The process included:

A detailed review of CRI’s procedures and documentation
A multi-day, on-site audit with independent reviewers
Interviews with subject matter experts across the organization
Verification that systems for data collection, storage, and reporting met strict requirements

“It’s truly everything,” said Dan Martin, senior manager of CRI’s Clinical Infrastructure team. “Every step of how a clinical study is run is evaluated—from the first plan to the final report.”

A proactive approach to quality

Previously, CRI demonstrated alignment with ISO 14155 through its broader quality certification (ISO 13485). However, evolving industry rules meant that approach would no longer be sufficient.

Rather than simply removing that reference, CRI chose to pursue standalone certification.

“We wanted to be clear and transparent about the standards we follow,” Hawkins said. “When the opportunity came to be certified directly, we saw it as the right step—not just for compliance, but for leadership.”

Supporting faster access to innovation

While CRI primarily supports internal work for Cook Medical, the impact of this certification extends beyond the organization.

More than just a piece of paper, this certification highlights CRI’s commitment to:

Consistently design and run studies to the highest quality standard
Reduce questions from regulators by strengthening the credibility of methods followed and clinical data collected
Improve efficiency in the approval process
Support faster access to new medical technologies for patients

A culture of innovation and collaboration

Achieving this milestone required coordination across teams in multiple countries, including contributors from Europe and Australia who participated across time zones.

“It was absolutely an all-hands effort,” Martin said. “We relied on experts across the organization to make this happen.”

The initiative also reflects a broader mindset within CRI and Cook Medical—one focused on continuous improvement and taking on new challenges.

“We don’t just want to follow what’s already been done,” Martin said. “We want to find better ways to get high-quality devices to the patients who need them.”

FAQ

What is ISO 14155?

ISO 14155 is an international standard that outlines best practices for clinical studies of medical devices involving human participants. It ensures studies are conducted ethically, safely, and with reliable data collection and reporting.

Why is this certification important?

Certification provides independent confirmation that a company’s clinical research processes meet global standards. This helps build trust with regulators, healthcare providers, and patients.

Does this change how clinical studies are conducted?

CRI was already following these principles. Certification formally verifies and strengthens those practices through independent review.

How does this benefit patients?

By improving the quality and consistency of clinical research, certification helps ensure that medical devices are evaluated thoroughly and efficiently — supporting faster access to safe and effective treatments.

Who provides the certification?

Independent organizations, sometimes called certification bodies, audit companies against international standards. In this case, CRI worked with TÜV SÜD.

Does this mean devices are approved faster?

Not automatically. All devices must still meet regulatory requirements. However, high-quality, trusted data can help reduce delays during the review process.

Key highlights

Cook Medical and Siemens Healthineers unveiled the fully integrated Interventional MRI Suite at SIR 2026.

iMRI enables a minimally invasive interventional practice ideal for precise soft tissue imaging, tumor targeting, biopsy and future ablation therapies, representing the future of radiation-free, image-guided care.

Attendees at SIR 2026 got to explore the suite, hear from expert interventional radiologists, learn more about the Cook and Siemens Healthineers partnership and listen to panels about the future of iMRI.

Fully integrated Interventional MRI Suite

Bloomington, Ind. — Cook Medical and Siemens Healthineers unveiled the integrated Interventional MRI (iMRI) Suite at the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting in Toronto. The collaboration brings together advanced magnetic resonance (MR) imaging, MR-conditional interventional devices and clinical workflow solutions designed to support minimally invasive procedures in an ionizing radiation-free environment. The unveiling marks a key milestone in the companies’ multi-year effort to advance MRI-guided intervention from concept to clinical reality.

The iMRI Suite provides a comprehensive framework for MRI-guided procedures. The solution combines imaging technology, purpose-built interventional devices, suite planning guidance and clinical education designed to support hospitals adopting MRI-guided interventions. The iMRI ecosystem will use SIR’s VIRTEX, a clinical data registry and analytics platform, to capture data, support continuous learning and help develop evidence-based protocols. The iMRI Suite is a turnkey solution that will give physicians more options for minimally invasive procedures that benefit from superior soft-tissue visualization and a radiation-free environment.

Attendees at SIR 2026 had the opportunity to meet world-renowned clinicians that are advancing clinical care with the newest interventional radiology (IR) techniques. Visitors at the booth got a sneak peek of Cook’s innovative pipeline of products, explored the physical suite environment, participated in demonstration sessions and heard from leading interventional radiologists discussing the emerging role of MRI-guided intervention. The discussions centered on these main topics:

Procedures that could benefit from real-time MRI guidance, particularly soft-tissue and oncology interventions, such as biopsies and ablations, as well as pediatric and cardiac indications

Workflow considerations for MRI-guided procedures

Integration of Cook’s MR-conditional interventional devices with the MAGNETOM Free.XL MRI system from Siemens Healthineers

The iMRI advisory board also discussed the ongoing development of iMRI Centers of Excellence, which are leading academic institutions collaborating with Cook Medical and Siemens Healthineers to advance research, clinical protocols and physician training in MRI-guided intervention. Most recently, Indiana University was named a Center of Excellence in the US. The advisory board will continue planning collaborations with high-profile research facilities across the US and Europe.

Keep up with the latest iMRI developments by following Cook Medical’s iMRI Division page on LinkedIn.

Quotes

“The iMRI Suite is more than a technology; it’s a fundamental shift in how we approach intervention. By bringing together advanced imaging, purpose-built devices, and integrated workflows, we are enabling physicians to see more, treat with greater precision, and ultimately deliver better outcomes without exposing patients or care teams to radiation,” said Peter Polverini III, vice president of Cook Medical’s iMRI divison.

“MRI offers unique advantages for image-guided intervention, particularly for procedures involving soft tissue. Through our collaboration with Siemens Healthineers and leading clinicians, we are working to advance the development of radiation-free interventional approaches,” said Pete Yonkman, president of Cook Medical and Cook Group.

“At Siemens Healthineers, it is our goal to elevate health globally. Magnetom Free.XL is designed to unlock the full potential of MR in the interventional suite, expanding the imaging toolbox by matching the right modality to the right patient at the right time”, said Andreas Schneck, head of Magnetic Resonance at Siemens Healthineers.

About iMRI

MRI provides exceptional soft-tissue visualization and eliminates exposure to ionizing radiation. While MRI has traditionally been used for diagnostic imaging, advances in device design and workflow are enabling its use in minimally invasive procedures. The iMRI Suite was developed to support this transition by creating an integrated environment for MRI-guided interventions.

In September 2025, Cook Medical’s iMRI division and Siemens Healthineers joined forces with leading strategic partners to deliver a fully integrated iMRI Suite. Cook brings procedural, device and training expertise, while Siemens brings world-leading imaging technology. Together, the companies are continuing a multi-year journey aimed at transforming interventional medicine by establishing the iMRI suite as the gold standard for precision, radiation-free procedures.

FAQs

What is Interventional MRI (iMRI)?

Interventional MRI (iMRI) refers to minimally invasive procedures performed using real-time MRI guidance. Unlike traditional interventional imaging modalities such as CT or fluoroscopy, MRI provides superior soft-tissue visualization and does not use ionizing radiation. This enables physicians to target certain tissues more precisely while avoiding radiation exposure for both patients and healthcare providers.

What is the iMRI Suite?

The iMRI Suite is an integrated procedural environment designed to support MRI-guided interventions. The solution combines Siemens Healthineers MRI imaging technology with Cook Medical’s interventional experience and compatible devices, along with suite planning guidance, clinical training and workflow support. The goal is to help hospitals implement MRI-guided procedures safely and efficiently.

What types of procedures could benefit from MRI-guided intervention?

MRI guidance may be particularly valuable for procedures involving soft-tissue structures where visualization is critical. Examples include biopsy and ablation procedures in organs such as the liver, kidney and prostate, as well as certain interventional oncology and pediatric applications. Clinical adoption will continue to evolve as physicians explore new use cases.

About Cook Medical

At Cook Medical, we are passionate about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing, manufacturing, and delivering medical devices, we provide healthcare professionals with the tools they need to help their patients return to living.

Our commitment to innovation involves bringing new products to market and keeping existing products relevant to a changing healthcare landscape. We believe in using our business to help people and communities thrive by creating inclusive, supportive, and healthy environments.

We are proud of our history of innovative firsts and the impact we have on patients and communities. With headquarters in Bloomington, Indiana, and manufacturing facilities and offices in various global locations, we challenge ourselves to maintain a global perspective while focusing on local impact.

Follow Cook Medical at CookMedical.com and on LinkedIn.

Cook Medical’s Syfonix® Suction Ureteral Access Sheath and the new 7.5 Fr Ascend™ Single-Use Flexible Ureteroscope are now available

Key highlights

The Syfonix Suction Ureteral Access Sheath is now commercially available in the U.S. and Canada.
Syfonix allows clinicians to manage suction right at the handle, helping maintain visibility and efficiency during ureteroscopic stone procedures.
The Ascend Single-Use Flexible Ureteroscope is now available in a new 7.5 Fr size in the United States and Canada.
Both products are part of Cook Medical’s complete portfolio of disposable urological medical devices. A complete portfolio is an economic advantage for customers on contract with Cook.

Cook Medical’s Syfonix® Suction Ureteral Access Sheath

Bloomington, Ind. — Cook Medical today announced the commercial launch of two products from its Urology specialty. The Syfonix® Suction Ureteral Access Sheath and the 7.5 Fr Ascend™ Single-Use Flexible Ureteroscope are available in the United States and Canada.

Syfonix is designed to give physicians fingertip control of suction during ureteroscopic kidney stone management procedures. With inner diameter ranges from 9 Fr to 12 Fr, the sheath establishes a working channel to facilitate the passage of endoscopes and ancillary instruments into the urinary tract. It is a single-use device.

Additionally, the Ascend Single-Use Flexible Ureteroscope is now available in a new 7.5 Fr size in addition to the 8.6 Fr size Cook has been offering. As Cook’s pipeline of products includes more products and more sizes, physicians are empowered to treat patients with more precision.

Cook Medical’s Ascend™ Single-Use Flexible Ureteroscope in 7.5Fr

Syfonix and Ascend are compatible products for stone management procedures. Together, these two products are part of Cook Medical’s full portfolio of urological disposables. Cook is proud to be a trusted source for a full line of disposables and the latest laser technology for urological healthcare providers. Having a complete portfolio provides a smoother customer experience for ordering products, especially for customers on contract. To learn more about Cook’s complete stone management portfolio, visit Cook Medical’s Urology specialty page.

Quotes

“Suction sheaths are a critical part of improving stone management procedures. Syfonix gives physicians seamless control of suction without having to break focus or rely on additional staff,” said Johan Lowinger, director of global product management for Urology at Cook Medical. “With the Syfonix sheath now available with the Ascend 7.5 Fr flexible ureteroscope, we’re excited to offer a solution that reflects direct feedback from the urology community.”

“Suction sheaths are one of the newest tools urologists have to help ensure patients get stone-free in a minimally invasive manner. Now that we have added Syfonix to our product portfolio, along with continuing to expand our Vision offering with the addition of the Ascend 7.5 Fr Ureteroscope, we’re giving physicians a full line of products to customize their treatment plan to the specific patient they’re treating. Commercializing these products in the US and Canada is an important milestone for Cook as we work alongside our clinical partners to further advance treatments in stone management,” said Shayna Martin, director of sales for Cook Medical’s Urology specialty.

About Cook Medical

Follow Cook Medical at CookMedical.com and on LinkedIn.

Key takeaways:

What: Cook Medical and Indiana University launch iMRI Center of Excellence to advance radiation-free, MRI-guided medical interventions.
How: The work spans two complementary initiatives: IU School of Medicine/MIRI medical imaging research infrastructure and the FAMES–Cook engineering initiative for MR-visible devices and to translate iMRI into clinical practice.
Impact: Creates replicable model for hospitals to implement safer MRI-guided interventions while eliminating radiation exposure for patients and medical staff

Bloomington, Ind. — Cook Medical has selected Indiana University as one of the first Interventional MRI (iMRI) Centers of Excellence. The collaboration is designed to accelerate the advancement, validation, and clinical integration of innovative MRI‑guided technologies and make certain medical procedures safer, more precise, and less invasive for patients.

From left to right, Sean Chambers, Director of Research and Development at Cook Medical; David Rosenberg, President and CEO of IU LAB; and Rohan Dharmakumar, Executive Director of the Medical Imaging Research Institute pose for a photo in the iMRI suite. The photo was taken at IU Indianapolis on Wednesday, March 4, 2026. (Photo by Liz Kaye/Indiana University)

The Center of Excellence builds on a five‑year agreement announced in 2025 between Cook Medical and the Indiana University Launch Accelerator for Biosciences (IU LAB) to translate IU research into real‑world health care applications. The collaboration underscores Cook’s broader focus on innovation.

What is the Interventional MRI (iMRI) Center of Excellence?

The iMRI Center of Excellence is a coordinated model that combines device engineering, imaging science, and clinical research infrastructure to speed the development and adoption of MRI‑guided technologies in hospitals and health systems. This practice allows doctors to treat patients without radiation risk while seeing soft tissues in greater detail, enabling more precise and potentially safer interventions.

A blueprint for radiation-free intervention

Indiana University will serve as the model site demonstrating the pathway for translating iMRI into future clinical practice. The university will create a working, real-world environment that hospitals and health systems can tour, learn from, and replicate as MRI-guided care grows in Indiana and beyond. The site will also support physician training and knowledge‑sharing as adoption expands, while helping prepare a new generation of iMRI technologists and clinical staff needed to support MRI-guided procedures nationwide.

“This Center of Excellence allows Indiana University to capitalize on our research strengths and convert them into real change for patients,” said David Rosenberg, president and CEO of IU LAB. “By bringing engineers, imaging experts, and the clinical excellence of the IU School of Medicine together in one place, we can move promising MRI-guided care ideas out of the lab and into hospitals more quickly – all in service of our goal to help patients benefit from safer, radiation-free procedures.”

“Indiana University School of Medicine is committed to making innovations that improve patient care,” said Jay L. Hess, MD, PhD, MHSA, dean of the Indiana University School of Medicine and executive vice president for university clinical affairs at Indiana University. “This partnership with Cook Medical combines world-class imaging, engineering expertise and clinical leadership. Through creating the iMRI Center of Excellence, we can accelerate the development of safer, more effective treatments for patients in Indiana and around the world.”

“We’re excited to name Indiana University as one of the first Centers of Excellence,” said Pete Polverini, vice president, interventional MRI division, Cook Medical. “Our mission for iMRI is bold: to enable safer, more precise, and more effective procedures using interventional MRI, and this collaboration reflects Cook’s accelerated approach to innovation and moving more quickly to bring our new ideas to patients.

Two complementary initiatives: engineering innovation + clinical integration

Ghazal Yoosefian, a Research Assistant at the Medical Imaging Research Institute of the IU School of Medicine, is collaborating with Yanni Pandelidis from Cook Medical in the lab. This photo was taken at IU Indianapolis on Wednesday, March 4, 2026. (Photo by Liz Kaye/Indiana University)

Indiana University and Cook Medical have launched two complementary initiatives spanning the full continuum of iMRI innovation, from advanced engineering of MRI‑visible devices to radiology and imaging research within the IU School of Medicine.

The IU School of Medicine’s Medical Imaging Research Institute (MIRI) will serve as the clinical and imaging research hub for the Center of Excellence, providing the imaging research and clinical research infrastructure, model iMRI suite, and dedicated personnel needed to validate, integrate, and translate MRI-guided technologies within real‑world procedural processes.

The FAMES–Cook initiative drives breakthrough engineering innovation by combining materials science, computational modeling, and advanced fiber manufacturing to develop MR‑visible and unique sensing devices designed specifically for interventional MRI environments.

Together, these initiatives connect engineers, imaging experts and physicians into one interdisciplinary system which accelerates translational research while positioning both organizations at the forefront of precision medicine.

About Cook Medical

Follow Cook Medical at CookMedical.com and on LinkedIn.

About Indiana University

Indiana University is one of the nation’s leading public research universities, with nearly 90,000 students across seven campuses, two regional academic centers and nine School of Medicine campuses. Since 1820, Indiana University has helped students create brighter futures, while also driving innovation, from breakthroughs in DNA technology to cancer research to trailblazing cultural programs and resources. IU is home to world-class academics with the country’s largest medical school, the world’s first school of philanthropy, the top-ranked Kelley School of Business and O’Neill School of Public and Environmental Affairs, and the Luddy School of Informatics, Computing and Engineering, the nation’s first school of informatics. The university’s campuses are united by IU 2030, an aspirational vision for a bold and ambitious future focused on student success and opportunity, transformative research and creativity, and service to the state of Indiana and beyond. Learn more at iu.edu.

FAQs

Q: What did Cook Medical and Indiana University announce?
A: They established Cook Medical’s first Interventional MRI (iMRI) Center of Excellence at Indiana University to accelerate the development and clinical adoption of MRI‑guided technologies.

Q: What is the purpose of the iMRI Center of Excellence?
A: To build a vertically integrated pipeline spanning engineering, imaging science, and clinical medicine—supporting validation, clinical integration, and translation of MRI‑guided technologies into real workflows.

Q: What are the two initiatives included?
A: The FAMES–Cook engineering initiative and the Interventional MRI Center of Excellence clinical research infrastructure initiative at the IU School of MedicineMedical Imaging Research Institute.