At the core of the launch is a redesigned pulse sequence, which delivers ablation significantly faster than earlier iterations while maintaining equivalent lesion outcomes. According to the company, the updated system operates with a lower temperature profile and achieves ablation speeds up to five times faster than the previous sequence. Built on the foundation of the Varipulse platform that received CE mark approval in 2024, the system enters an increasingly competitive European market that includes technologies such as Volt (Abbott), Farapulse (Boston Scientific), PulseSelect (Medtronic), Globe (Kardium), Centauri (CardioFocus) and PulseMagic (MicroPort EP). The Varipulse PFA catheter is positioned as a continuation of Johnson & Johnson’s iterative approach to innovation in electrophysiology.

“The introduction of Varipulse Pro in Europe reflects our commitment to advancing our PFA platforms through continuous innovation, enhancing procedural experience while maintaining the consistency and precision physicians expect from the Varipulse Platform,” said Michael Bodner, company group chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “This launch demonstrates our dedication to continuously evolving PFA technologies based on real-world learnings and our scientific expertise, supporting physicians to deliver high-quality care and improved patient outcomes.”

The system maintains compatibility with the Carto 3 mapping system, which provides 3D cardiac mapping capabilities used in electrophysiology procedures. This integration enables features such as tissue proximity indicators to support accurate lesion placement. Early clinical use has been carried out within the VARIPURE multicenter, prospective, post-market follow-up study, with further data generation planned as part of the broader commercial rollout. The company also intends to present the technology and related findings at the European Heart Rhythm Association annual meeting and the EHRA PFA summit. The Varipulse PFA catheter remains investigational in the U.S.

“In our early experience, Varipulse Pro has been exceptionally smooth and easy to use,” said Dr. Tom De Potter, head of electrophysiology and associate director of the Heart Center, OLV Hospital, Aalst, Belgium. “The speed is particularly striking and contributes to more efficient procedures without compromising precision. The integration with CARTO mapping and intracardiac echocardiography (ICE) facilitate accurate positioning and consistent lesion delivery, contributing to a very positive procedural experience.”

With the expanded funding, AI Airlock is expected to scale its operations and support the development of sustainable regulatory pathways for AI-driven medical technologies. Delivered through collaboration between MHRA, DHSC, the NHS AI Team, and Team AB, the programme aligns with broader government strategies, including the AI Opportunities Action Plan, the Regulatory Action Plan, the 10-Year Health Plan, and the Life Sciences Sector Plan.

Commenting on the development, James Pound, Executive Director, Innovation and Compliance, said:
“Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.
The programme has already shown how collaborative, real-world testing can uncover regulatory challenges early and help innovators bring high-quality, safe technologies to patients faster.
This additional investment will allow us to scale up and ultimately strengthen our ability to ensure that AI-powered medical devices can reach patients safely, efficiently and with the confidence of robust regulatory oversight.”

The AI Airlock programme has evolved steadily since its pilot launch in 2024, followed by a second phase in 2025 that broadened its scope. Early findings highlighted new regulatory complexities associated with AI medical devices, particularly around risk management, accuracy, and the need to anchor model outputs in verified clinical data. It also underscored the importance of explainability in AI systems to strengthen clinician trust, alongside the necessity for continuous post-market monitoring to detect performance shifts or over-reliance.

Building on these insights, the second phase has examined specific regulatory challenges, including AI-powered diagnostic tools, pre-determined change control plans (PCCPs), and evolving use cases of AI systems. The programme has tested a wide spectrum of technologies such as large language models, voice-enabled tools, and advanced diagnostics targeting cancer and rare diseases. Outputs from this phase, including reports and case studies, are expected in Summer 2026 and will guide the design of phase three. Findings are also feeding into the National AI Commission’s work on shaping future regulatory frameworks. As AI Airlock expands, it continues to play a central role in strengthening collaboration between regulators and industry, supporting safe innovation while maintaining a robust and future-ready regulatory environment for medical devices.

At the operational level, the BD® Pyxis™ Pro Dispensing Solution is engineered to improve how medications are stored, accessed, and managed within hospital environments. Its modular, stackable design allows for increased storage capacity within the same physical footprint, accommodating both refrigerated and ambient medications. This approach supports healthcare systems in adapting to shifting patient needs while maintaining consistent medication availability. Enhanced security features such as RFID badge scanning, wireless barcode scanners, and illuminated bins aim to strengthen controlled substance management and simplify medication retrieval processes. In this context, the AI medication dispensing system is positioned as a tool to reduce inefficiencies and disruptions across clinical workflows.

The expansion also includes plans to extend the AI-enabled BD Incada™ Analytics platform already established in the United States to European hospitals and health systems next year. Built on Amazon Web Services’ (AWS) on-demand cloud computing infrastructure, the BD Incada™ Platform integrates advanced AI capabilities, including natural language search in analytics. The system is designed to scale alongside the data generated by nearly three million connected BD devices, offering clinicians enterprise-wide visibility into medication inventory through customizable dashboards. These capabilities support pattern identification, improved medication availability, reduced waste, and enhanced labor efficiency.

To address regional requirements, BD will utilize the AWS European Sovereign Cloud, enabling EU healthcare systems to meet digital sovereignty standards while maintaining performance, security, and scalability. “BD’s innovations in medication management are setting a new standard for unified, data-driven healthcare operations,” said Esteban Rossi, vice president and general manager for Medication Management Solutions, EMEA at BD. “Delivering the BD® Pyxis™ Pro Dispensing Solution and BD® Incada™ Platform directly to European hospitals empowers our customers to strengthen medication availability, improve efficiency and enhance patient care.” The Pyxis™ Pro Dispensing Solution is expected to be deployed across Europe in the coming months, with support for 15 languages.

The Asurys system can be integrated with the LithoVue Elite single-use digital flexible ureteroscope, enabling real-time monitoring of intrarenal pressure. When paired, physicians can directly control irrigation from the scope handle, streamlining procedural workflows. The platform also includes an on-demand flush feature, activated via the ureteroscope, allowing repositioning of stones without requiring manual irrigation or assistance from support staff. Beyond ureteroscopy, the system is indicated for use in percutaneous nephrolithotomy (PCNL), cystoscopy, and benign prostatic hyperplasia (BPH) procedures.

Boston Scientific indicated that a limited market release of the Asurys system in the US will begin in the coming days. The company emphasised the system’s ability to respond dynamically to procedural requirements, particularly in maintaining irrigation efficiency while controlling pressure levels.

Boston Scientific Urology chief medical officer Dr Ronald Morton said: “Based on feedback gathered through our work with urologists, we know measuring and managing intrarenal pressure (IRP) while maintaining irrigation flow for visualisation is increasingly important.

“Until now, there has not been a system that can automatically respond to IRP data in real-time. The Asurys fluid management system can automatically regulate irrigation inflow to help minimise the potential of exceeding physician-selected IRP settings.”

Earlier this year, Boston Scientific also reported data outlining the benefits of spinal cord stimulation (SCS) therapies within its neuromodulation portfolio.

The Vascade MVP XL system had earlier received FDA clearance in June 2024 as a mid-bore closure device. It incorporates a 25F diameter disc along with 19 milligrams of resorbable, thrombogenic collagen. Prior to this expanded indication, its U.S. usage covered procedural sheaths ranging from 10-12F ID and up to a maximum of 15F OD. The latest approval broadens that scope, aligning the vascular closure system with evolving procedural demands in electrophysiology.

According to Haemonetics, the system is currently the only extravascular venous closure system clinically proven for electrophysiology procedures utilizing up to 17F OD procedural sheaths. The design removes the need for physicians to downsize procedural sheaths during closure, a step that can otherwise extend procedural duration. By maintaining compatibility with larger sheath sizes, the system supports workflow efficiency during complex interventions.

Clinical validation supporting the approval comes from the AMBULATE EXPAND trial, which involved 77 patients in the U.S. The study assessed the system’s performance in PFA and LAAC procedures, reporting 0% major and 0% minor access site closure-related complications. Additionally, the median time to ambulation was recorded at 2.4 hours.

Ken Crowley, VP and GM, Interventional Technologies at Haemonetics, said:

“Vascade MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers. With label expansion approval for fast-growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centers across the U.S.”

The development of DeviceGuide took place in collaboration with Edwards Lifesciences, combining Philips’ imaging and AI capabilities with Edwards’ expertise in structural heart therapies. The software is tailored to enhance workflow efficiency during mitral transcatheter edge-to-edge repair (M-TEER), which serves as a minimally invasive alternative to open-heart surgery for patients with mitral regurgitation. Through workflow optimization and guided navigation, AI DeviceGuide supports clinicians in executing these demanding procedures with improved consistency.

At its core, the system leverages Philips’ echo-fluoro fusion technology to merge live ultrasound and X-ray imaging into a unified display. Its AI-driven algorithm automatically tracks and visualizes the repair device in real time, enabling more precise positioning during procedures. “The AI software serves as an assistive tool; the physician always remains in control. This isn’t about replacing expertise – it’s about amplifying it,” said Atul Gupta.

Development efforts included collaboration with investigational sites across Europe and the U.S., notably at the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Irving Medical Center. The work involved Susheel Kumar Kodali, MD, and Rebecca T. Hahn, MD. “Since AI auto-aligns imaging to the device in real time and continuously informs the interventionalist about the location of the device in space on the imaging screen, it minimizes unnecessary repositioning of the imaging window, streamlines procedural guidance, and may improve the precision of device implantation,” said Dr. Rebecca T. Hahn. The solution integrates with Philips’ Azurion image-guided therapy platform and aligns with its broader connected cardiology strategy.

The Medtronic ViaVerte deal positions the company more directly against competitors such as Boston Scientific, which offers the Intracept BVNA system following its 2023 acquisition of Relievant Medsystems, and Stryker, which received FDA clearance for its own BVNA system in May 2025. Medtronic indicated that the agreement builds on its series of strategic initiatives aimed at strengthening core franchises. It also deepens its collaboration with Merit Medical, which currently supplies the Kyphon KyphoFlex unipedicular balloon catheter. The companies stated that the ViaVerte BVNA system is expected to become available later this year.

“For 50 years, we have advanced how chronic pain is treated,” said Paolo Di Vincenzo, president, Medtronic Neuromodulation, which is part of the Medtronic Neuroscience Portfolio. “Adding ViaVerte basivertebral nerve ablation expands our world-leading pain interventions portfolio and gives patients and their physicians another meaningful option for lasting relief.”
“We are thrilled to expand our ongoing business relationship with Medtronic by providing Merit’s proprietary articulating technology. We believe ViaVerte represents a significant advancement in the BVNA market.”
“This agreement underscores our mutual dedication to providing innovative therapies to support physicians and their patients.”

BTIG analysts Sam Eiber, Marie Thibault and Alexandra Pang maintained a “Buy” rating for Merit following the announcement. They highlighted that limited details were disclosed about ViaVerte beyond its physician-controlled steerable mechanism. While describing the BVNA segment as a “relatively small market” estimated at around $200 million, the analysts pointed to its rapid growth, supported by activity from Boston Scientific and Stryker. “We are pleased to see Merit enter this fast-growing and under penetrated market and think Medtronic makes sense as a partner given its Neuromodulation portfolio,” the analysts wrote. “It could also serve as one lever to help the OEM business get back on more stable footing.”

The Photonova Spectra platform is engineered to deliver broad coverage alongside ultra-high definition (UHD) spatial and spectral imaging. According to GE HealthCare, the system enables faster acquisition speeds and supports detailed visualization of subtle tissue variations, small lesions and vascular structures. Unlike conventional CT systems that convert X-rays into light before measurement, photon-counting CT directly detects individual X-ray photons and measures their energy. This approach allows for improved spatial and spectral resolution, as well as enhanced tissue characterization. The company also highlighted that its Deep Silicon detector material strengthens spectral imaging performance, particularly in lesion characterization and treatment monitoring. GE HealthCare submitted Photonova Spectra for FDA clearance in November 2025, incorporating advanced AI applications into the platform.

As clinicians across the United States face rising volumes and increasing diagnostic complexity, technology must do more than capture images it must simplify decision-making and strengthen performance across the enterprise, said Catherine Estrampes, President & CEO, U.S. and Canada, GE HealthCare. Photonova Spectra is designed to deliver rich clinical insights in every scan and help alleviate cognitive burden for care teams. With the U.S. 510(k) clearance, we are proud to now bring this innovation to U.S. healthcare systems and the patients they serve.

Further technical capabilities of Photonova Spectra include 8-bin energy resolution enabled by Deep Silicon, supporting advanced material separation and characterization. This allows clinicians to distinguish materials such as iodine, calcium and fat with greater clarity. The system’s wide detector coverage and rapid rotation speed of 0.23 seconds contribute to fast acquisition and motion-free imaging. Additionally, Photonova Spectra captures both 8-bin spectral and ultra-high definition spatial data simultaneously without requiring specialized protocols, ensuring spectral data is available in every exam.

GE HealthCare noted that the system has applications across neurology, oncology, musculoskeletal imaging, thoracic imaging and cardiology. It supports visualization of fine brain structures, characterization of lesions, detection of small fractures and bone marrow edema, and advanced cardiac and chest imaging. The platform also leverages Nvidia computing technology, enabling it to process up to 50 times more data than conventional CT systems. Ongoing collaborations with UW-Madison and Stanford Medicine are focused on exploring new clinical applications and imaging protocols. With regulatory approval in place, GE HealthCare is now preparing for commercial availability of Photonova Spectra in the U.S.

Photonova Spectra reflects years of intentional design and close collaboration with clinicians, researchers and collaborators across the globe, adds Jean-Luc Procaccini, president & CEO, Molecular Imaging and Computed Tomography, GE HealthCare. From the earliest stages to today, we remain focused on building a system that addresses the practical realities of clinical practice while opening pathways for scientific advancement. The result is a photon-counting platform engineered for the needs of today’s care teams, as well as the imaging challenges and research opportunities that will shape the future of CT.

Northwell, one of the largest U.S. health systems, is already working with 18 Enterprise Ireland companies, with existing engagements delivering procurement contracts, clinical pilots and trials, as well as strategic investments. Under the renewed framework, Enterprise Ireland client companies will retain direct access to Northwell’s clinical experts spanning 28 hospitals and more than 1,000 outpatient facilities. In addition, companies will be able to leverage Northwell’s innovation ecosystem and commercial infrastructure, strengthening pathways for Irish medtech expansion in a competitive global market.

The announcement aligns with Enterprise Ireland’s broader strategy to grow the Irish medtech sector internationally, following its end-of-2025 report highlighting sector expansion. Alongside this partnership, Galway-based Neurent Medical, supported by Enterprise Ireland, has also entered into an agreement with Northwell. Neurent develops the Neuromark system for treating chronic rhinitis, a device designed with a flexible shaft and atraumatic leaflets to conform to patient anatomy and reach difficult areas within the nasal cavity. The system delivers impedance-controlled, low-power radiofrequency (RF) energy to disrupt parasympathetic nerve signals, addressing symptoms such as persistent nasal congestion and rhinorrhea (runny nose). The next-generation Neuromark system received FDA clearance in June 2025, while Neurent raised $74 million (€62.5 million) in an oversubscribed Series C financing round earlier this year. With a U.S. headquarters in Braintree, Massachusetts, the company aims to scale further through this collaboration.

Enterprise Ireland also highlighted a broader wave of U.S. expansion by Irish firms, including Shorla Oncology, Fire1, Head Diagnostics and X-Bolt. These companies are strengthening their commercial, clinical and partnership footprints across the U.S., reflecting continued momentum in Ireland’s life sciences ecosystem. Government and industry leaders underscored the importance of such partnerships in enabling Irish innovation to reach global markets.

“Northwell Health has been an invaluable partner to Ireland and to Irish health tech and medtech companies. This alliance has provided Irish companies with unparalleled opportunities and privileged access to Northwell Health’s vast clinical network, serving as a critical gateway for innovative Irish companies entering and scaling within the U.S. healthcare market. Ireland’s life sciences and health tech sector is thriving, and partnerships like this are central to ensuring that innovation emerging from Ireland reaches patients in the U.S. and around the world.”

“Northwell Health is proud to sign this new strategic alliance with Enterprise Ireland and build upon years of successful collaboration. Our International Business Program has proven to be an invaluable gateway for innovative international companies seeking to enter and scale within the U.S. healthcare market. Since 2016, we have provided Enterprise Ireland client companies with direct access to clinical experts across one of America’s largest health systems, resulting in meaningful outcomes including procurement contracts, clinical pilots and trials, and strategic investments from Northwell Ventures. We look forward to welcoming the next generation of Irish healthcare innovators and supporting their growth in the U.S. market.”