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.

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.

Alignment Efforts to Streamline Regulatory Pathways

The collaboration focuses on improving and aligning regulatory frameworks governing medical device approvals, with both agencies exploring mutual recognition mechanisms. These mechanisms are intended to allow partial acceptance of each other’s approval processes, reducing duplication and creating more efficient pathways for manufacturers operating across both markets.

Technical discussions are underway to identify areas where regulatory convergence can be implemented without compromising safety, quality, or effectiveness standards. While alignment will increase, both regulators will retain independent authority over final approvals.

According to Lawrence Tallon, the initiative will support faster and more efficient access to advanced medical technologies, reinforcing regulatory efficiency within both healthcare ecosystems.

Policy and Trade Integration

The regulatory developments are closely tied to wider policy changes under the US-UK partnership. The US has lifted tariffs on pharmaceuticals and medical technologies imported from the UK for at least three years, reducing trade barriers and strengthening cross-border supply chains.

In parallel, the UK has outlined plans to increase pharmaceutical spending to 0.6% of GDP by 2035, signalling long-term investment in healthcare innovation. The UK’s pharmaceutical sector, which contributes £28.5 billion annually and exports nearly £21 billion in drug products, underpins this strategic direction.

Operational Impact on Healthcare Systems

From a healthcare management perspective, accelerated medical device approvals are expected to influence system-level operations:

• Shorter timelines for adoption of new diagnostic and therapeutic technologies
• Reduced regulatory complexity for cross-border technology deployment
• Greater predictability in procurement and capital planning
• Enhanced access to innovative MedTech solutions

The UK’s MedTech sector, employing over 195,000 people, stands to benefit from improved regulatory clarity and faster routes to market. Lord Vallance noted that the partnership strengthens regulatory leadership while supporting innovation uptake.

Strategic Implications for Market Access

Industry bodies including the Association of British HealthTech Industries and techUK have highlighted that regulatory alignment will provide more predictable pathways for innovators, particularly small and medium-sized enterprises.

As observed by HHM Global, the initiative reflects a broader shift toward globally connected regulatory systems, where harmonisation reduces friction in bringing new technologies to market while maintaining high safety standards.

Outlook

Ongoing technical work between the MHRA and FDA will determine the scope of future alignment and mutual recognition frameworks. Any resulting agreements will remain subject to stringent regulatory requirements, ensuring that safety and performance benchmarks are upheld.

The advancement of medical device approvals alignment marks a significant step toward more integrated healthcare systems, with implications for regulatory efficiency, procurement strategies, and innovation adoption.

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.”

The organisations confirmed that the merger, while financial terms remain undisclosed, will establish what they describe as the largest clinical reporting network in the UK. The combined service is set to span major diagnostic subspecialties and expand capacity to manage both routine and urgent cases.

Medica currently delivers remote teleradiology reporting services to radiology departments across 55% of NHS Trusts. Its clinical focus areas include stroke imaging, cardiac, PET CT, and nuclear medicine, supporting hospitals with off-site specialist expertise.

Axon Diagnostics operates in digital pathology, working with NHS and private healthcare providers to manage caseloads and enable remote reporting workflows. Its cloud-based teleradiology and telepathology platform underpins these services, allowing clinicians to access and report cases remotely.

Through the integration of Axon’s platform and artificial intelligence (AI)-based workflow tools alongside clinical desktop technology from Axon’s sister company, MITIS Medica stated that the enlarged organisation will introduce more streamlined workflows. The aim, it said, is to enhance efficiency and cost effectiveness for clients, in line with the NHS’s long term priorities.

The announcement comes against the backdrop of the UK government’s 10-year plan for the NHS, unveiled in July 2025. In that plan, the UK’s Labour government highlighted the acceleration of AI deployment in hospitals to support clinical reporting in radiology and pathology. The strategy also emphasised remote monitoring to enable virtual care for patients at home.

Medica CEO Andrew Cannon commented: “Bringing Axon into Medica strengthens our position as the UK’s leading diagnostics provider. Clients will continue to receive the excellent service they rely on, now supported by greater capacity and advanced reporting technology.”

To finalise the merger, both companies said they are implementing a phased integration plan designed to bring together their systems, teams, and best practice protocols in a “structured and transparent” manner.

Axon CEO Rahul Mehta commented: “This merger combines our technology and agile approach with Medica’s scale and clinical excellence, meaning more patients will benefit from faster and smarter reporting.”

The transaction also unfolds amid workforce pressures in UK radiology. According to the Royal College of Radiologists (RCR), the country faces a 30% shortfall in clinical radiologists, a figure projected to increase to 40% by 2028 if no corrective measures are taken. In response to these constraints, teleradiology has increasingly served as a key stopgap solution, helping to ease clinician burnout while addressing rising caseloads.

The deal opens access to the European Union’s USD 572.3 billion pharmaceuticals and medical devices market, giving Indian companies preferential or zero-tariff entry, while EU firms benefit from India’s tariff reductions on imported medical equipment.

Together, India and the EU represent close to a quarter of global GDP and serve a combined population of nearly two billion people. Announcing the deal, European Commission President Ursula von der Leyen said, “We did it, we delivered the mother of all deals,” while Prime Minister Narendra Modi described the agreement as “historic”.

Under the India-EU Free Trade Agreement, India will reduce or eliminate customs duties on around 90% of medical and surgical equipment categories. Tariffs that currently reach as high as 27.5% will gradually fall to zero, easing the cost burden on imported European technologies.

The moves will likely reduce the price of purchasing these advanced imaging devices such as CT scanners, MRI machines and ultrasounds along with critical-care gear and high-end diagnostics. These items already constitute a major portion of imports into India of medical technology products, especially those used in tertiary and quaternary care.

Hospitals and diagnostic networks are likely to see improved access to advanced equipment, while patients may benefit from wider availability of cutting-edge technologies and reduced capital expenditure pressures across healthcare systems.

At the same time, Indian manufacturers gain improved access to European markets. Tariffs of up to 6.7% on medical instruments, devices, and related products are set to be removed across more than 99% of applicable lines, strengthening the export outlook for Indian MedTech companies.

Rajiv Nath, Forum Coordinator, AiMeD, said, “The India-EU FTA must ensure a level playing field for India’s medical device manufacturers. With fair regulatory alignment and safeguards against predatory imports (especially from 3rd countries), this agreement can unlock high-value collaboration, boost domestic manufacturing, and support India’s ambition to become a top-five global MedTech hub. The goal should be mutual growth anchored in quality, transparency, and patient safety under an MRA(mutual recognition agreement) based on common ISO standards. We look forward to reviewing the fine print and the follow-on cooperation discussions.”

Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), added, “We congratulate India and the European Union on concluding this landmark agreement, which is expected to open a new chapter in healthcare cooperation – where success will be measured not only in GDP, but in lives improved and saved… Most importantly for patients, any eventual tariff reductions on medical devices should help improve affordability and access to advanced therapies, making this agreement a potential example of how ethical and equitable trade can reinforce health systems on both sides.”

Signals from the industry and policy makers suggest new openings for Indian-made medical devices, consumables, lenses, spectacles and in-vitro diagnostics produced at hubs located in Gujarat, Maharashtra, Karnataka and Andhra Pradesh. Lowering the costs for in-vitro diagnostics firms, zero tariff access will make them more competitive in Europe if companies adhere to stringent EU regulations.

The collaboration is expected to drive efforts in genomic diagnostics, with the eventual goal of improving patient outcomes and helping to guide future care. The organizations have also announced the launch of a prospective observational study called “Serial Molecular Profiling and Monitoring of Human Cancer.” Patients participating in the study will undergo sequencing at various time points during treatment to generate the longitudinal datasets that will be critical to the effort.

In addition to the initial research study, other work included in the collaboration involves assay validation, biomarker identification, biological modeling, real-world data analysis, and the development of artificial intelligence-powered predictive algorithms. The work is in addition to Tempus’ current role as a provider of next-generation sequencing testing services to NYU Langone Health.

“Through the integration of advanced genomic technologies and data science, we are deepening our understanding of cancer’s complexity and pioneering transformative approaches for patient monitoring and treatment,” said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus. “Our research is focused on generating actionable insights through better understanding of cancer response, resistance, and trajectory that will not only refine and enhance current assays, but also drive the creation of innovative diagnostic tools and algorithms that can empower clinicians to deliver truly individualized care to their patients.”

The Tempus-NYU Langone collaboration will be carried out within routine clinical care at the Perlmutter Cancer Center, allowing researchers to study serial molecular profiling in real-world settings.

“This strategic collaboration will further our ability to analyze cutting-edge serial molecular profiling technology in the routine care of patients at the Perlmutter Cancer Center at NYU Langone Health,” said Shridar Ganesan, MD, PhD, Director of the Center for Molecular Oncology at Perlmutter Cancer Center. “This approach will enable us to better understand the biology of individual cancers, inform our ability to implement and develop targeted therapies, and assess response and emerging resistance.”

On December 29, 2025, Judge Lance Walker went on to rule in favor of the American Hospital Association as well as other provider plaintiffs when it comes to granting a preliminary injunction.

HHS has been barred from executing the rebate program pending a further order, said Walker.

On the same day that the court went on to rule in favor of the hospitals, Robert F. Kennedy Jr., the HHS Secretary, appealed the decision to the United States Court of Appeals. The next day, on December 30, 2025, Walker denied the motion in order to stay the preliminary injunction pending the appeal.

Also, December 30, 2025, pharmaceutical companies such as Pharmacyclics, AstraZeneca Pharmaceuticals, AbbVie LP, Boehringer Ingelheim Pharmaceuticals, and Novo Nordisk, along with the Pharmaceutical Research and Manufacturers of America, went ahead and appealed to the Court of Appeals for the First Circuit on a decision from the federal court in Maine in order to deny them the intervenor status.

Apparently, the 340B rebate pilot should have gone into effect on January 1, 2026.

The American Hospital Association, along with other groups, went ahead and sued to prevent implementation of a model that, according to them, would harm the safety net providers.

The model would alter the hospital reimbursement for drugs in the 340B program from being upfront payments to back-end rebates.

Defendants say that a stay is indeed required so as to prevent any sort of disruption of industry preparation in order to execute a pair of major programs that have taken effect on January 1, 2026. Walker confirmed.

Interestingly, the judge went on to rule in favor of the American Hospital Association as well as other plaintiffs since HHS did not meet the minimum benchmarks set by the Administrative Procedure Act of the government before commencing a new program or policy.

Walker added that those minimal needs are simply that agency action should be reasonable as well as reasonably explained, as the ruling said.  The government had to offer a reasoned explanation for its action.

There are competing directives when it comes to officer price concessions as per both 340B and the Drug Price Negotiation Program from the Inflation Reduction Act.
as per the court.

The Health Resources and Services Administration planned to begin a hastily assembled 340B Rebate Model Pilot Program on January 1, 2026, so as to deduplicate such kinds of price concessions, the ruling said.

This has gone on to involve a rather threadbare administrative record, which likely fails to consider as well as reasonably explain the effect of a rebate model when it comes to 340B hospitals, which depend on the upfront price concessions to go ahead and stretch few resources as much as possible in order to serve the rural and poor communities, Walker remarked. The APA is likely in need of more from defendants.

Apparently, the merger is pending final legal as well as regulatory approval; however, it is anticipated to get finalized by April 2026, city officials cited.

The partnership has the support of $2.2 billion over the next five years from New York State in order to protect safety net healthcare within Brooklyn, the officials said.

Notably, Maimonides Health is a Brooklyn healthcare system having three hospitals and over 80 community-based sites. Through partnering with the city, Maimonides is going to be reimbursed at a much higher rate by Medicaid, hence bolstering its financial health and position, the health system executives went on to say in a press release.

The merger also enables Maimonides to embrace a new Epic electronic health record – EHR platform. Health system executives went on to say that the move to Epic is going to help enhance care coordination along with the ability of the organization to collect revenue. Maimonides patients are going to be able to get access to their health records online and also have an option to contact their care team digitally by way of the portal.

According to Eric Adams, New York City Mayor, through bringing two storied health care systems together in one umbrella, they will make sure that Brooklynites, as well as all New Yorkers, can continue to get the high-quality care that they actually deserve. It is worth noting that NYC Health + Hospitals is actually the envy of cities everywhere, and New Yorkers actually trust the care they get at its 11 hospitals as well as many other patient care sites.

This sort of effort preserves and also strengthens the care in his home borough of Brooklyn and is indeed going to be great for the thousands of patients who make use of Maimonides every day added Adams.

Mitchell Katz, M.D., President and CEO of NYC Health + Hospitals, said that this is indeed quite an exciting opportunity for NYC Health + Hospitals along with Maimonides, two institutions having their own respected history as well as traditions and both committed to offering high-quality care for all the New Yorkers. Katz added that all their 11 hospitals have their own identity and culture, and Maimonides is going to retain its distinct character along with its commitment to all the communities it goes on to serve. As they move forward, they are going to work with its incredible, dedicated clinicians as well as staff in order to make sure of a smooth transition for everyone, specifically its patients.

Interestingly, Gov. Kathy Hochul went on to announce the $2.2 billion grant on October 16, 2025. The Health Care Safety Net Transformation Program motivates building partnerships with safety-net institutions through offering strategic capital as well as operating support, besides the required regulatory agility, in order to improve the resilience as well as sustainability of safety-net hospitals and to also expand the access to high-quality care.

Joining NYC Health + Hospitals is going to enable Maimonides to keep offering the necessary specialty care, as per Ken Gibbs, Maimonides Health President and CEO. He adds that they are grateful to have a partner who goes on to share their commitment to working along with communities in order to meet their requirements, and that they are grateful to Mayor Adams, Governor Hochul, and Dr. Katz for offering them this very distinct opportunity to go ahead and broaden their access to care throughout Brooklyn.

It is worth noting that NYC Health + Hospitals is the largest municipal healthcare system in the country that serves over a million New Yorkers per year across more than 70 patient care locations throughout the five boroughs of the city. The health system’s network, when it comes to outpatient, neighborhood-based primary as well as specialty care centers, goes on to anchor care coordination along with the trauma centers, nursing homes along with post-acute care centers, home care agency, and MetroPlus health plan of the system. NYC Health + Hospitals apparently employs over 46,000 people.

NYC Health + Hospitals went on to note that the organization, under the leadership of Katz since September 2017, had gone through many changes in order to enhance its finances, including consolidating its EHRs throughout the system, which helps with better care coordination along with data collection, and also went on to expand its team of financial counselors, who enable the patients to enroll in health insurance if they are eligible, said the health system executives.

Notably, in fiscal 2025, the direct patient care revenue of NYC Health + Hospitals went on to surpass $5.7 billion, which was an increase of over $2.5 billion from fiscal 2019. The healthcare system now has its patients within primary care, with 459,000 in fiscal 2025, which was an increase of almost 43,000 patients from fiscal 2018.

Besides this, Ronovo also signed an agreement with Johnson & Johnson Medical Shanghai Ltd. in order to expand its surgical technology offerings across hospitals in parts of China. This partnership happens to cover the Carina robotic surgery platform of Ronovo for soft tissue procedures as well as complementary J&J surgical products.

Ronovo, which happens to be Shanghai-based, has also said it has started an international expansion, which goes on to include the regulatory submissions throughout Europe as well as South America.

Ronovo which has raised $67M Series D funding by JJDC has already gone on to raise over $100 million in 2024, which happens to include its Series C round that was led by Granite Asia. The company has already brought in $44mn in Series B financing in 2024, after securing over $50 million in the past.

According to its CEO, John Ma, who also happens to be a former Intuitive Surgical executive, Ronovo is indeed committed so as to democratize the access to surgical robotics on a worldwide scale.

Ma and Ying Mao, who happens to be the chief operating and technology officer, went on to found Ronovo in 2019. Mao comes from Auris Health, the Monarch robot developer, which J&J went on to acquire in 2019.

It is well to be noted that the Carina robot from Ronovo went on to receive the regulatory approval from the National Medical Products Administration of China in March 2025 when it comes to general surgery, gynecology, urology, and thoracic surgery. This modular soft tissue platform goes on to address the agility and adaptability as well as affordability challenges that happen to be posed by the legacy robotic surgical systems. This partnership along with J&J is indeed going to speed up the commercial momentum in China and at the same time also lay the foundation when it comes to international growth, opined Ma.

Ronovo is going ahead and also scaling up in a very crowded field pertaining to surgical robots, thereby challenging the grip of Intuitive on the market. J&J itself is also preparing to come up with a soft tissue robot named Ottava in the U.S. and has also said that it has plans to submit a de novo application to the FDA in the first quarter of next year.

On the other hand, Intuitive has faced certain barriers in the China market ever since 2022, when numerous provinces went ahead and set limits on what hospitals can charge the patients as far as surgeries using robotic technology are concerned. The limits have indeed gone on to affect the various procedures that are performed, and also Intuitive’s instruments as well as accessories revenue have not had a material effect on the business as of June 2025, said the company in its security filing report.