As the clinical research landscape continues to evolve, the need for faster, more efficient data processes has become critical. IgniteData, having achieved significant sponsor growth in 2025, is at the forefront of enabling frictionless data exchange that accelerates drug development and enhances operational efficiency.

During the conversation, Taft discusses how streamlined data integration is helping reduce delays in clinical trials and ensuring that life-saving treatments reach patients sooner. He also highlights IgniteData’s collaborations with leading U.S. cancer centers and its role in addressing long-standing challenges in oncology trials, particularly in reducing administrative burdens and improving data accessibility for research teams.

The interview further explores the industry’s transition away from traditional Electronic Data Capture (EDC) systems. Taft shares his perspective on what reduced reliance on EDC could mean for clinical research sites and how organizations can adapt to this shift while maintaining data integrity.

Additionally, the discussion touches upon the complexities of expanding across global markets and the importance of ensuring data efficiency across diverse regulatory environments.

Looking ahead, Taft outlines the next wave of innovation in clinical research, emphasizing the importance of interoperability, efficiency, and patient-centric approaches in shaping the future of healthcare.

In preparation for the rollout, the European Medicines Agency has scheduled an online information session on 24 April 2026. The session will outline key elements of the Breakthrough Devices framework and address practical considerations for stakeholders intending to participate. This step is expected to help manufacturers better understand procedural requirements and align early with regulatory expectations.

The pilot draws from the recently adopted MDCG 2025-9 guidance issued by the Medical Device Coordination Group. It also aligns with broader regulatory revisions proposed by the European Commission in December 2025, which introduced new provisions under Article 52a of the Medical Devices Regulation and Article 48a of the In Vitro Diagnostic Regulation. These updates aim to formalise a future framework for breakthrough medical technologies within the EU.

Positioned as a strategic move, the programme reinforces efforts to foster an innovation-oriented regulatory landscape across Europe. To secure a breakthrough designation, manufacturers must seek an opinion from the agency’s expert panels, with additional guidance and application templates expected ahead of the launch. The pilot also supports wider objectives tied to public health priorities, ensuring that advanced medical technologies entering the EU market continue to meet stringent quality, safety, and performance benchmarks. The Breakthrough Devices pilot is therefore expected to play a defining role in shaping future regulatory processes while strengthening confidence in high-impact innovations. The Breakthrough Devices pilot further underlines the EU’s commitment to balancing innovation with robust oversight.

The current shortage is largely driven by concentrated global production and geopolitical instability. A significant share of helium supply originates from Qatar, with exports heavily dependent on transit routes such as the Strait of Hormuz. Disruptions in this corridor, alongside damage to production infrastructure, have constrained global availability. Since helium is a by-product of natural gas extraction, its supply cannot be easily scaled in response to demand, further tightening market conditions.

MRI systems at the centre of the disruption

Magnetic Resonance Imaging (MRI) remains the most exposed segment within healthcare. These systems rely on liquid helium to cool superconducting magnets to temperatures close to absolute zero, enabling stable, high-resolution imaging.

• MRI scanners typically require around 1,500 litres of liquid helium
• Healthcare accounts for nearly 30% of global helium consumption
• Helium has no viable substitute in MRI cooling systems
• Periodic refilling is required throughout a scanner’s lifecycle

As supply tightens, radiology departments face increasing uncertainty around maintenance and refilling cycles. Unlike sudden equipment failures, helium shortages create a gradual decline in system reliability. Reduced helium levels can limit scanning capacity, increase downtime risks, and complicate servicing.

This directly affects diagnostic workflows. Delays in MRI availability can extend timelines for cancer detection, neurological assessments, and surgical planning, placing additional strain on already burdened healthcare systems.

Expanding impact across clinical and research applications

Beyond MRI, the helium shortage impact extends into multiple layers of healthcare and life sciences:

• Nuclear Magnetic Resonance (NMR): Essential for drug development, molecular analysis, and pharmaceutical quality control
• Cryogenic research systems: Used in advanced biological and medical research requiring ultra-low temperatures
• Specialised surgical and laboratory processes: Where inert, ultra-cold environments are necessary

These applications rely on helium’s unique ability to maintain extremely low temperatures without chemical reactivity. Its physical properties make substitution impractical, meaning shortages can halt or delay critical research and laboratory operations.

Cost pressures and procurement instability

The shortage has triggered sharp price increases, with helium costs rising by an estimated 50–70% in recent months. For healthcare providers, this translates into immediate financial pressure, particularly for institutions operating multiple MRI units or large research facilities.

Procurement is further complicated by helium’s storage limitations. Due to its low boiling point and tendency to escape containment, long-term stockpiling is not viable. Most healthcare systems depend on continuous supply, leaving them exposed to market volatility and logistical disruptions.

This has forced procurement teams to prioritise allocation, renegotiate supplier contracts, and explore alternative sourcing strategies, often under tight operational constraints.

System-wide ripple effects on healthcare infrastructure

The helium shortage is also revealing deeper interdependencies within healthcare supply chains. The same geopolitical disruptions affecting helium are influencing energy markets, shipping routes, and industrial inputs.

• Semiconductor production—dependent on helium—may face constraints, affecting medical devices and digital health technologies
• Pharmaceutical manufacturing faces rising costs due to energy and logistics disruptions
• Transport bottlenecks are increasing lead times for critical medical supplies and equipment

These interconnected pressures highlight how upstream resource constraints can cascade into healthcare delivery, affecting both clinical services and supporting infrastructure.

HHM Global notes that such disruptions underline the growing need for resilience across healthcare systems, where access to critical materials directly influences service continuity and patient outcomes.

Industry response: reducing dependency and improving resilience

Healthcare providers and equipment manufacturers are actively adapting to mitigate supply risks. Several strategies are gaining traction:

• Low-helium MRI systems: Newer designs significantly reduce helium usage, with over 1,000 units deployed globally
• Helium recycling technologies: Systems that capture and reliquefy helium, enabling reuse within facilities
• Supplier diversification: Reducing reliance on single geographic sources
• Operational prioritisation: Allocating helium to critical applications during shortages

Helium recovery systems, in particular, are emerging as a key solution. By creating closed-loop usage models, hospitals can reduce dependence on external supply while maintaining imaging and research continuity.

HHM Global highlights that such technological adoption reflects a broader shift toward operational self-sufficiency, particularly in environments where uninterrupted diagnostic capability is essential.

Long-term outlook: from commodity to critical asset

The current crisis is repositioning helium as a strategic healthcare resource rather than a routine consumable. Its role in sustaining diagnostic capacity, research capability, and advanced medical technologies makes it integral to modern healthcare infrastructure.

In the long term, addressing the helium shortage impact will require a combination of supply diversification, technological innovation, and more efficient resource management. Expanding production, improving recycling systems, and prioritising critical healthcare usage will be central to stabilising the market.

For healthcare systems, the lesson is structural: resilience now depends not only on clinical expertise and infrastructure, but also on securing access to critical materials that underpin everyday medical operations.

As policymakers and industry leaders prepare to gather at Interclean 2026, new insights highlight the significant economic and societal contribution of Europe’s tissue sector – an often overlooked but essential pillar of daily life, hygiene, and public health.

According to ETS’ latest socioeconomic impact analysis, the tissue industry:

• Supports over 421,000 jobs across Europe, with employment extending far beyond manufacturing into retail, logistics, and services
• Generates €19.7 billion in annual revenue, highlighting the sector’s role in Europe’s industrial and economic ecosystem
• Delivers 8.2 million tonnes of essential tissue products each year, supporting hygiene in homes, healthcare, and public spaces
• Plays a critical role in hygiene standards, particularly in healthcare settings, public facilities, and high-traffic environments

At a time when Europe is navigating complex discussions around sustainability, public health, and industrial policy, these findings underscore the importance of a balanced, evidence-based approach to hygiene solutions.

“Tissue products are a cornerstone of modern hygiene systems,” said Carlos Reinoso, Director General of the European Tissue Symposium (ETS). As policymakers consider future regulations, it is essential to recognise both the economic contribution of our sector and the critical role tissue plays in protecting public health. Decisions must be grounded in science, lifecycle thinking, and real-world usage.”

The findings contribute to the broader sustainability debate by highlighting the importance of lifecycle thinking, hygiene performance, and practical implementation.

Meet ETS at Interclean 2026

ETS will be present at Interclean 2026, engaging with policymakers, industry stakeholders, and media to discuss the implications of the study for Europe’s regulatory and sustainability landscape.

Journalists and attendees are invited to connect with ETS on-site to explore:

• The full socioeconomic impact of the tissue industry
• The role of tissue in maintaining hygiene and public health
• The importance of evidence-based policymaking in sustainability discussions

Media Opportunities

• On-site meetings with ETS representatives
• Access to key data and insights from the socioeconomic impact study
• Expert commentary on hygiene, sustainability, and regulatory developments

To arrange a meeting or interview, please contact:
Nadia Del Rio | press@europeantissue.com

As part of the agreement, member companies will gain access to discounted international shipping services, with savings of up to 60% across offerings such as FedEx International Priority® Express, FedEx International Priority®, and FedEx International Economy. These solutions are positioned to address the time-sensitive and compliance-driven requirements of medical device exports, leveraging FedEx’s global logistics network to provide reliable and flexible delivery capabilities. The collaboration also introduces a structured support framework through educational webinars and one-on-one consultations focused on customs clearance procedures, regulatory compliance, and export optimization strategies.

The broader backdrop for this FedEx KMDIA partnership reflects sustained growth in Korea’s medical device sector, supported by rising demand for diagnostic reagents, aesthetic laser systems, and rehabilitation equipment. The country’s biohealth industry is forecast to expand by 20.8% to USD 290 billion in 2026, marking its fastest growth since 2019, with projections indicating a further increase to USD 357 billion by 2029. In parallel, the Korean government has outlined plans to invest approximately USD 628 million between 2026 and 2032 to accelerate research and development in medical devices, reinforcing its ambition to position the sector as a national growth engine.

“We are excited to collaborate with KMDIA to support Korean medical device manufacturers and exporters as they scale globally,” said Wonbin Park, managing director of FedEx Korea. “With our global network, industry expertise and differentiated logistics solutions, FedEx is well positioned to help K-biohealth compete on the world stage and contribute to the government’s vision of developing medical devices into a new national growth engine.”

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.

The transaction carries a total value of approximately $140m, including assumed liabilities. Merit paid $90m in cash at closing, while the remaining $50m will be disbursed in two deferred payments of $25m each, scheduled no later than the first and second anniversaries of the closing date. With the integration of View Point’s capabilities, Merit is broadening its offering in oncology procedures that require precise tumour localisation and imaging support.

View Point Medical is known for manufacturing the OneMark detection imaging system along with OneMark tissue markers. Cleared by the US Food and Drug Administration, the OneMark platform combines a surgical detection console with ultrasound-enhanced tissue markers. These markers are designed to remain visible across standard imaging modalities after placement, while also minimising interference during imaging procedures. When used alongside Merit’s SCOUT platform, the system may reduce the need for additional pre-surgical procedures to identify tumour locations.

From 1 April 2026 through 31 December 2026, Merit expects the acquisition to generate between $2m and $4m in revenue, while reducing previously forecast non-GAAP earnings per share by $0.05. Over the 12 months ending 31 December 2027, revenue contribution is projected to reach between $14m and $16m, with the deal anticipated to become accretive to non-GAAP earnings per share.

Merit Medical Systems president and CEO Martha Aronson said: “This acquisition expands Merit’s portfolio of therapeutic oncology products dedicated to the accurate diagnosis and localisation of breast and soft tissue tumours.

“View Point’s unique ultrasound-enhanced technology offers a highly innovative solution to localise more lesions at the time of biopsy – representing an estimated 1.3 million procedures annually in the US alone.”

Financial advisory services for the deal were provided by Piper Sandler, while legal counsel was handled by Baker & McKenzie.

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 combination is expected to bring together Bioniq’s biomarker-based formulation approach with Pro2col’s digital health application and Link BioSciences’ processing of biometrics, biomarkers, lifestyle data, DNA, and application-derived inputs. Herbalife states that these additions will enable it to provide a broader portfolio of customized supplements across multiple delivery formats, reinforcing its positioning in personalized nutrition at scale.

“The future of health and wellness is becoming more personalized and informed by data,” says Stephan Gratziani, Herbalife CEO. “By combining Bioniq’s personalized supplement technology with Pro2col and the power of our global distributor network, we are expanding our ability to deliver personalized wellness at a global scale.”

The transaction is expected to close in Q2 of 2026, subject to customary closing conditions and regulatory approvals. The company plans to introduce Bioniq’s solutions to customers in the US and select European markets later this year through its distributor network.

Bioniq’s platform combines a patented personalization framework, individual health data, and a proprietary biomarker database to generate supplement formulations suited to a wide spectrum of users, from general consumers to high-performance athletes. “I founded Bioniq in 2019 with a vision to help people optimize their well-being through a science-driven approach to nutrition that incorporates biomarker and lifestyle data,” says Vadim Fedotov, founder and president of Bioniq. “I am excited to join Herbalife with its global distributor network and commitment to advancing wellness at scale.”

Herbalife has also secured a call option to acquire Bioniz LAB, a platform focused on small molecules and peptides, enabling evaluation of longer-term opportunities. Cristiano Ronaldo, a nutrition partner of Herbalife and shareholder in Bioniq, supports the strategy. “Throughout my career, biometrics and personalized nutrition have been central to helping me perform and compete at the highest level,” says Ronaldo. “I’ve experienced firsthand how a tailored approach to nutrition can help optimize performance.” He adds, “I’m delighted to see Bioniq’s personalized supplements become part of Herbalife’s expanding access to nutritional supplements, helping people take a more informed approach to their health, wellness, and performance.”

The deal comes amid continued consolidation across the nutrition sector. Danone recently agreed to acquire Huel to expand its functional nutrition offering, while Lone Star Funds announced plans to acquire the Capsules & Health Ingredients division of Lonza Group. In parallel, Darling Ingredients and Tessenderlo Group combined collagen and gelatin operations into a new entity expected to generate US$1.5 billion in revenue.

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.”