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.”

At the core of medical device manufacturing advancing global supply is a shift toward more resilient and diversified supply chains. The vulnerabilities of the traditional global model were laid bare during recent years, as logistical bottlenecks and material shortages highlighted the risks of over-reliance on a single geographic region. Today, the industry is moving toward a multi-hub approach, where manufacturing capabilities are strategically distributed to mitigate risk and ensure a stable flow of essential medical goods. This trend is not about deglobalization, but about a more sophisticated form of resilient globalization, where medical device manufacturing advancing global supply is supported by a network of localized production centers that can rapidly scale or pivot in response to a crisis.

The Strategic Role of OEM Partnerships in MedTech

A significant portion of the innovation in this sector is driven by OEM (Original Equipment Manufacturer) partnerships. Many of the world’s leading medical device brands do not actually manufacture every component of their products. Instead, they rely on specialized OEM medical devices partners who possess the specific engineering and production expertise required for high-precision components. These partnerships are a cornerstone of medical device manufacturing advancing global supply, as they allow for a more agile and efficient use of resources. By outsourcing the production of specialized parts to an OEM partner, a medical technology company can focus its internal efforts on research, clinical trials, and regulatory compliance, effectively accelerating the time-to-market for new life-saving innovations.

These OEM relationships are built on a foundation of rigorous quality management and regulatory alignment. In the medical device industry, there is no margin for error. Every component, no matter how small, must meet the exacting standards of the FDA, EMA, and other international regulatory bodies. Therefore, the choice of a manufacturing partner is a strategic decision that goes far beyond cost. It is about finding an organization that shares a commitment to quality-by-design and possesses the necessary ISO certifications to operate in a highly regulated environment. This collaborative model is a primary engine of medtech production, ensuring that even the most complex devices can be manufactured at a scale that meets the needs of a global population.

Precision Engineering and Advanced Materials in Healthcare Manufacturing

The physical reality of medical device manufacturing advancing global supply is defined by the incredible precision of modern engineering. We are now entering an age where devices are becoming smaller, more intelligent, and increasingly biocompatible. This requires a level of manufacturing expertise that was once the exclusive domain of the aerospace or semiconductor industries. For example, the production of micro-stents for cardiovascular surgery or ultra-thin electrodes for neural implants demands cleanroom environments and microscopic assembly techniques that are at the absolute cutting edge of human capability. This focus on device engineering is what allows for the creation of tools that are not only more effective but also less invasive, significantly improving the patient experience.

Furthermore, the use of advanced materials is a key driver of healthcare manufacturing. The development of new polymers, titanium alloys, and bio-absorbable materials is opening up new possibilities for long-term implants and wearable sensors. These materials must be processed with extreme care to ensure they do not trigger an immune response or degrade prematurely within the human body. By integrating these material sciences into the production process, medical device manufacturing advancing global supply is providing clinicians with more durable and reliable tools than ever before. This is particularly evident in the field of orthopedics, where 3D printing and additive manufacturing are now being used to create patient-specific implants that mimic the exact structure of a person’s bone, leading to better integration and faster healing times.

Scalable Production and Global Supply Chain Resilience

One of the greatest challenges in medical device manufacturing advancing global supply is the need for scalability. A medical breakthrough is only as good as our ability to produce it in sufficient quantities to help those in need. This requires a transition from the lab-scale prototype to a mass-scale production environment without any loss of quality or precision. This is where advanced automation and digital twin technology are playing a crucial role. By creating a virtual model of the production line, manufacturers can simulate and optimize the manufacturing process before a single physical part is ever made. This not only reduces waste but also ensures that the final production system is robust and capable of meeting global demand.

Moreover, the resilience of the global medical supply chain is being bolstered by better data integration. Manufacturers are increasingly using blockchain and real-time tracking to monitor the movement of raw materials and finished products from the factory floor to the hospital loading dock. This level of visibility is essential for medical device manufacturing advancing global supply, as it allows for a more proactive approach to inventory management. If a supplier in one part of the world experiences a delay, the manufacturer can quickly identify an alternative source, ensuring that there is no disruption in the availability of critical medical devices. This connected supply chain is a fundamental component of a more stable and equitable global healthcare system.

Regulatory Compliance and Quality-Driven Systems

The most critical factor in medical device manufacturing advancing global supply is, and always will be, patient safety. This is why every aspect of the manufacturing process is governed by a complex and ever-evolving web of regulations. Compliance is not just a legal requirement it is a moral obligation. High-quality medical device manufacturing is characterized by a culture of quality that permeates every level of the organization. From the initial design phase to the final inspection, every step is documented, verified, and audited to ensure that the device performs exactly as intended. This commitment to quality is what builds trust between the manufacturer, the clinician, and the patient.

As we look to the future, the harmonizing of international regulatory standards will be a key factor in further medical device manufacturing advancing global supply. Currently, manufacturers often have to navigate different sets of rules for the US, Europe, and Asia, which can slow down the distribution of new technologies. Efforts to create a more unified global regulatory framework will allow for a more rapid and efficient response to global health challenges. By continuing to innovate in both the engineering and the regulatory aspects of the industry, we can ensure that medical device manufacturing advancing global supply remains a robust and reliable pillar of the modern world, bringing the latest medical advancements to every corner of the globe.

The core of clinical laboratory automation improving testing efficiency is found in the total laboratory automation (TLA) models. In these systems, a sample is placed on a track and navigated through the entire analytical process from sorting and centrifugation to analysis and storage without any human intervention. This hands-off approach is the hallmark of modern clinical lab systems, as it drastically reduces the potential for human error. In a manual lab, the risk of mislabeling a tube or incorrectly pipetting a reagent is a constant concern. However, in an automated environment, every sample is tracked by a barcode and handled by robotic arms that operate with sub-millimeter precision. This not only ensures the integrity of the test but also significantly reduces the turnaround time (TAT), allowing physicians to receive critical results while a patient is still in the emergency room or the operating suite.

The Impact of Robotic Sample Processing on Workflow

One of the most significant bottlenecks in traditional diagnostics is the pre-analytical phase. This stage includes the sorting, uncapping, and preparation of various biological samples, such as blood, urine, and tissue. Historically, this work was performed by laboratory technicians, who spent hours on repetitive tasks that were both time-consuming and prone to causing repetitive strain injuries. The emergence of robotic sample processing as part of clinical laboratory automation improving testing efficiency has fundamentally changed this dynamic. Modern pre-analytical workstations can sort and prepare hundreds of tubes per hour, ensuring that they are ready for the analyzer the moment they arrive in the lab. This initial speed is crucial, especially for time-sensitive tests like cardiac troponin or blood glucose levels, where every minute counts for the patient’s outcome.

Beyond the immediate speed of processing, these robotic systems contribute to a much safer work environment. Laboratory personnel are frequently exposed to biohazardous materials, and manual handling of open tubes increases the risk of aerosolization and accidental needle sticks. By utilizing clinical laboratory automation improving testing efficiency, the lab can keep samples closed and contained for as much of the process as possible. The robots handle the dirty work, allowing the highly trained human staff to focus on the thinking work interpreting complex results, maintaining the equipment, and troubleshooting rare diagnostic anomalies. This shift in roles is a key benefit of diagnostic laboratory technology, as it elevates the profession of laboratory medicine from manual labor to data-driven clinical consultation.

Digital Lab Management and Real-time Data Integration

While the hardware of clinical laboratory automation improving testing efficiency is impressive, the brain of the modern lab is the Laboratory Information Management System (LIMS). These digital platforms are the connective tissue that links every piece of robotic hardware to the hospital’s electronic health records. When a sample is scanned at the point of collection, the LIMS immediately knows which tests are required and directs the automated track to send the sample to the appropriate analyzer. This seamless integration is essential for lab efficiency solutions, as it eliminates the need for manual data entry and reduces the risk of clerical errors. Furthermore, these systems provide laboratory managers with real-time data on the status of every sample, allowing them to identify and resolve bottlenecks before they impact patient care.

The use of clinical laboratory automation improving testing efficiency also allows for autoverification of results. This process uses complex algorithms to review test results against a patient’s historical data and known physiological ranges. If a result is within normal parameters and consistent with previous tests, the LIMS can automatically release the result to the clinician without a manual review. This drastically speeds up the reporting process for the vast majority of normal tests, leaving the laboratory specialists with more time to focus on the critical or abnormal results that require expert clinical judgment. This blend of robotic efficiency and human expertise is the ultimate goal of clinical laboratory automation improving testing efficiency, creating a system that is both faster and more reliable than either could achieve alone.

Scalability and the Global Demand for Diagnostics

The global demand for diagnostic testing is increasing at an exponential rate. Factors such as an aging population, the rise of chronic diseases like diabetes and cardiovascular disorders, and the increasing use of personalized medicine are putting unprecedented pressure on laboratory resources. In this context, clinical laboratory automation improving testing efficiency is not just a convenience it is a necessity for the sustainability of the healthcare system. Automated labs are inherently scalable, meaning they can handle a significant increase in testing volume without a proportional increase in staff or physical space. This efficiency is particularly vital during public health crises, such as the COVID-19 pandemic, where the ability to rapidly scale up PCR testing was a critical component of the global response.

Furthermore, these lab efficiency solutions are becoming more accessible to smaller community hospitals and diagnostic centers. While the initial investment in a TLA system can be significant, the long-term cost savings in terms of reduced labor, decreased reagent waste, and fewer errors make it a compelling financial decision. As the technology matures, we are seeing the emergence of modular clinical laboratory automation improving testing efficiency, where a lab can start with a single robotic module and add more as their needs grow. This democratization of diagnostic laboratory technology ensures that patients in rural or underserved areas can receive the same high-quality, rapid diagnostics as those in major metropolitan medical centers.

The Future of Automated Laboratory Medicine

As we look to the future, the next frontier for clinical laboratory automation improving testing efficiency is the integration of artificial intelligence and advanced molecular diagnostics. We are moving toward a world of smart labs that can not only process samples but also predict when a piece of equipment is about to fail or when a specific reagent is running low. AI will play a greater role in the analytical phase, helping to interpret complex genomic sequences or identify rare cellular abnormalities in blood smears with a level of accuracy that exceeds human capability. This evolution will further solidify the role of clinical laboratory automation improving testing efficiency as the backbone of precision medicine.

The ultimate vision is a fully integrated diagnostic ecosystem where the lab is not a separate department but a seamless part of the patient’s clinical journey. From the moment a sample is drawn, it is part of a high-speed, data-driven process that delivers actionable insights directly to the physician’s fingertips. By continuing to innovate in the field of clinical laboratory automation improving testing efficiency, we are not just making labs faster we are making healthcare more responsive, more accurate, and more human. The robots may be doing the work, but the benefit is felt by every patient who receives a timely diagnosis and a personalized path toward healing.

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.

At the core of the platform is its ability to generate a patient-specific, simulation-ready digital replica of the lungs. By embedding directly into CT imaging workflows, the system uses deep learning models to reconstruct a detailed 3D digital twin, offering clinicians an interactive view of anatomical structures such as airways, blood vessels, lung lobes, and lesions. This AI Lung Digital Twin Platform enables practitioners to simulate bronchoscopy and biopsy pathways, facilitating improved procedural planning within an immersive digital environment.

The platform is built on NVIDIA Physical AI infrastructure, incorporating NVIDIA Omniverse and OpenUSD for interactive visualization, NVIDIA TensorRT for optimized AI inference, and NVIDIA MONAI for advanced image segmentation. These components collectively support automated identification of critical lung structures, volumetric analysis, and navigation path planning. By transforming static CT scans into dynamic models, the system allows clinicians to better assess anatomical relationships, reduce pre-operative planning time, and improve procedural safety across complex interventions.

“By combining LTTS’ engineering expertise in medical imaging and digital health platforms with the power of NVIDIA’s Physical AI infrastructure, we are enabling a new generation of AI-powered biological digital twins for precision medicine,” observed Amit Chadha, CEO & Managing Director, L&T Technology Services. “These platforms can transform how clinicians visualize lung anatomy, plan interventions and deliver precision care. The impact will be visible across the global healthcare ecosystem in the years ahead.”

David Niewolny, Head of Business Development for Healthcare and Medical Technology, NVIDIA, said, “Digital twins are emerging as a powerful new tool for precision medicine. By leveraging NVIDIA Physical AI infrastructure, Omniverse, MONAI and TensorRT, LTTS is transforming CT data into interactive lung digital twins that allow clinicians to visualize anatomy in 3D, simulate procedures and plan clinical interventions with greater confidence.”

Rising global cases of respiratory diseases, including lung cancer and COPD, are accelerating the adoption of AI-driven digital twin technologies. These innovations are expected to shift clinical workflows away from conventional imaging interpretation toward predictive, simulation-led, and minimally invasive intervention planning, supporting more personalized and data-driven treatment strategies.

The revised framework introduces regulatory sandboxes that allow AI solutions to be tested in real-world healthcare environments, ensuring systems are trained on high-quality, real-life datasets. Ong noted that while HSA has yet to receive any registration applications for AI-developed drugs, it remains open to such submissions. He also emphasised that HSA “will take a technology-neutral approach to regulation, applying the same rigour to AI-developed drugs as it does to conventional drugs”. This approach comes as AI continues to reshape drug development, particularly through the use of simulated laboratory data that can replace early-stage clinical trials, which are often costly and time-intensive.

In parallel, HSA has achieved a significant milestone by becoming the first national regulatory authority to reach the World Health Organization’s highest level of medical device regulation. This designation allows HSA to act as a global reference point for other regulators. Ong highlighted that several jurisdictions—including Australia, Hong Kong, Malaysia, the Philippines, South Africa, Sri Lanka, Switzerland, Thailand and the United Kingdom—already reference HSA approvals to accelerate their own regulatory processes. At the same time, HSA aligns its standards with major regulatory systems such as those in the US, European Union, UK and Japan, reinforcing its international credibility.

Singapore is also part of a consortium with Australia, Canada, Switzerland and the UK that facilitates the approval of new therapeutic products, helping improve access to safe and effective pharmaceuticals. Ong stated that these initiatives position Singapore as more than a domestic market, expanding its relevance to hundreds of millions globally. Adjunct Professor Raymond Chua added that HSA’s WHO recognition supports its evolving economic role in strengthening the biomedical sector. He said: “The future of healthcare will not be shaped by innovation alone, but by the wisdom with which we govern it.” Moving forward, Singapore plans to integrate regulatory functions and align product development with priority disease areas such as cardiovascular diseases, diabetes and metabolic disorders, supporting simultaneous progress in regulatory approval, clinical development and health technology assessment.

The system is specifically designed for patients with quadriplegia caused by cervical spinal cord injuries. By using a glove connected to the interface, the technology enables patients to regain hand-grasping ability. Classified as an invasive BCI system, the device functions by inserting electrodes directly into the brain rather than placing them on the brain’s surface. The system uses minimally invasive extradural implantation combined with wireless technology to facilitate communication between the brain and the external device.

China’s National Medical Products Administration said that Brain-Computer Interface products such as the newly approved system have been given priority regulatory attention. The regulator noted that the BCI sector has been identified as a “future industry” in Beijing’s latest five-year plan released last week. The move reflects the country’s efforts to accelerate development and deployment of emerging neurotechnology platforms.

Eligibility requirements for the device include patients aged 18 to 60 who suffer from a specific form of spinal cord injury. The diagnosis must have been established for at least one year, and patients must have remained in a stable condition for six months following standard treatment. Candidates must also be unable to grasp objects with their hands while still retaining some level of upper-arm function.

According to the regulator, clinical trial data showed significant improvement in hand-grasping ability among participants, with the improvement contributing to a better quality of life for patients involved in the trials.

“At MiniMed, every advancement begins with listening to the needs of people living with diabetes,” said Que Dallara, CEO of MiniMed. “By offering more sensor flexibility within a fully integrated system backed by the proven clinical outcomes of our MiniMed™ 780G system1,2,3,4 we’re helping lighten the burden of daily management and giving individuals the freedom to choose what works best for them.”

The MiniMed 780G system already supports the Guardian™ 4 and Simplera Sync™ sensors, each designed to provide up to seven days of wear time. Following the latest approval, the system will also operate with the Instinct sensor, which has been developed exclusively by Abbott for MiniMed’s automated insulin delivery (AID) system. The Instinct sensor is described as the world’s smallest, thinnest and most discreet continuous glucose monitoring (CGM) sensor and can be worn for up to 15 days.

With the addition of the Instinct sensor, individuals using the MiniMed™ 780G system can now select between sensors offering either 7-day or 15-day wear durations, enabling greater flexibility depending on personal preference and lifestyle requirements. MiniMed plans to introduce the MiniMed™ 780G system with the Instinct sensor commercially in the first European countries during the summer of 2026. The company also intends to showcase the complete system at the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2026) scheduled to take place in Barcelona from March 11–14, 2026. In Europe, the MiniMed™ 780G system is indicated for individuals aged two years and older with insulin-requiring diabetes (type 1 and type 2) whose total daily insulin dose is six units or more, and the system is also CE marked for use during pregnancy.

The SmartHeart goes on to simplify one of the most technically demanding MRI exams, easing the workload of technologist and at the same time making sure of an image quality that’s consistent.

When it comes to patient comfort, the SmartHeart cuts the number of breath holds by almost 75%, hence enhancing the comfort for patients with conditions such as dyspnea, arrhythmias, or even anxiety.

The fact is that broader access to cardiac MR could help with much earlier detection and more confident diagnosis along with proactive management of heart disease.

According to Business Leader MR at Philips, Ioannis Panagiotelis, PhD, “Cardiac MR is one of the most powerful tools available to assess the heart, yet its complexity and exam length have historically constrained its broader clinical impact. With SmartHeart embedded directly into the planning workflow, Philips is fundamentally redefining how CMR is performed – transforming it from a highly specialized, time-intensive procedure into a streamlined, intelligent, and scalable solution. This empowers clinicians to deliver consistent, precision cardiac care to significantly more patients.”

Part of the full AI-enabled cardiac MR suite by Philips

CINE FreeBreathing – Helps with diagnostic-quality imaging without breath-holds.

Cardiac Motion Correction – MoCo – Corrects the cardiac and respiratory motion for more definitive diagnoses.

CardiacQuant Perfusion – Offers quantitative evaluation when it comes to myocardial perfusion for subtle deficits.

Cardiac MR Suite by Philips expands access to precision cardiac care by way of reducing dependence on highly specialized operators. It also supports productivity gains in cardiology and radiology departments without compromising on the quality of diagnosis.

The Cardiac MR Suite indeed positions Philips as a leader in AI-driven cardiac MR innovation, transforming CMR into a much more scalable as well as a streamlined solution.