The test is performed using Fujirebio’s fully automated LUMIPULSE® G1200 instrument system, which is already widely available in clinical laboratories across the United States. By enabling automated, accessible plasma-based testing, this advancement offers a less invasive alternative to traditional cerebrospinal fluid (CSF) testing or amyloid PET imaging. The new plasma ratio test complements Fujirebio’s Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which was authorized by the FDA for use in CSF samples in May 2022. Together, these diagnostic tools expand the capabilities of clinicians to detect Alzheimer’s-related pathology earlier and more accurately, supporting improved patient care and timely intervention.
“The lack of effective, accessible, and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in the early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”
The Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test offers a highly accurate, minimally invasive, and accessible method for measuring plasma concentrations of phosphorylated tau 217 (pTau 217) and β-Amyloid 1-42. These biomarkers serve as a proxy for β-Amyloid plaque pathology in the brain, a hallmark of Alzheimer’s disease. The test is intended for use in adults aged 50 and older who are exhibiting signs and symptoms of cognitive decline and are being evaluated in a specialized care setting. In a clinical study involving 499 patients, designed to reflect U.S. demographic diversity, the test demonstrated strong performance. Using a dual cut-point approach, it achieved a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%. Notably, only 20% of patients were classified as indeterminate, potentially requiring additional confirmatory testing, highlighting the test’s utility in reducing diagnostic uncertainty and guiding next steps in clinical evaluation.
As per DelveInsight’s “Alzheimer’s Disease Diagnostic Market Report”, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2025 to 2032. The Alzheimer’s disease (AD) diagnostic market is observing an optimistic market growth due to factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand of Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, the presence of key players in the market, increasing product launches and approvals, and other factors will create a requirement for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2025 to 2032.
Stryker Received FDA Clearance for OptaBlate® BVN System, Offering a New Minimally Invasive Solution for Chronic Vertebrogenic Low Back Pain Through Targeted Basivertebral Nerve Ablation
On May 19, 2025, Stryker, a global leader in medical technologies, announced that its OptaBlate™ Basivertebral Nerve Ablation (BVN) System received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks a significant advancement in the treatment of chronic vertebrogenic low back pain. The OptaBlate BVN System is designed for use in a targeted, minimally invasive procedure that delivers long-lasting† relief of vertebrogenic pain, a condition associated with damage or inflammation of the basivertebral nerve.
The system leverages Stryker’s expertise in radiofrequency ablation technology and vertebral access, representing the convergence of two of the company’s core competencies. With this addition, Stryker further expands its advanced pain therapy portfolio, offering healthcare providers and patients an innovative solution that addresses a challenging source of chronic low back pain. The OptaBlate BVN System reinforces Stryker’s commitment to delivering effective, evidence-based treatments across the continuum of care.
“We often see patients with chronic low back pain who have tried multiple treatments—physical therapy, injections, medications—without lasting relief,” said Dr. Jad Khalil, Spine Surgeon at Michigan Orthopaedic Surgeons. “BVNA is a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific MRI findings. Before BVNA, options for lasting relief were limited. For many, it offers meaningful improvement and can help avoid more aggressive treatments like surgery.”
“We have a long history in radiofrequency ablation, and we’re relentlessly committed to delivering groundbreaking approaches to protect and promote quality of life,” said Kristen Berg, vice president and general manager of Stryker’s Interventional Spine business. “Our legacy providing solutions to reduce pain now continues with OptaBlate BVN, addressing the underserved population suffering from chronic vertebrogenic lumbar pain.”
The OptaBlate™ BVN System is engineered with key features that enhance precision, efficiency, and safety during vertebrogenic nerve ablation procedures. The system is capable of achieving a lesion of at least 1 cm in just 7 minutes, supporting swift and effective treatment. Its steerable, dynamically curved introducer allows for targeted navigation and placement, optimizing procedural accuracy. Additionally, the system incorporates microinfusion technology, which maintains hydration within the ablation zone—this helps to reduce impedance errors and prevent tissue charring, promoting consistent energy delivery. The procedure is further supported by 10-gauge access tools, enabling reliable vertebral entry and instrument control. These features collectively position the OptaBlate BVN System as a robust solution for delivering lasting vertebrogenic pain relief through a minimally invasive approach.
As per DelveInsight’s “Radiofrequency Ablation Devices Market Report”, the global radiofrequency ablation devices market was valued at USD 3.64 billion in 2023, growing at a CAGR of 9.37% during the forecast period from 2024 to 2030 to reach USD 6.19 billion by 2030. The demand for radiofrequency ablation devices is witnessing growth due to the growing prevalence of chronic diseases such as cardiovascular diseases, cancers, a rising geriatric population, and technological advancements in product development and design improvement.
Abbott Announced Landmark Clinical Results Showing Libre® CGM as First Continuous Glucose Monitor Linked to Reduced Hospitalizations from Heart Complications in People with Diabetes
On May 15, 2025, Abbott announced new findings from its REFLECT real-world studies, revealing that the use of FreeStyle Libre® continuous glucose monitoring (CGM) technology is significantly associated with a reduced risk of hospitalization for heart-related complications in people living with diabetes. For the first time, evidence demonstrates that CGM use can help mitigate the severity of cardiovascular complications in individuals with Type 1 diabetes, regardless of their prior history of low blood sugar episodes or hospitalizations related to heart disease. Additionally, similar benefits were observed among people with Type 2 diabetes who use insulin, with the FreeStyle Libre biowearable technology contributing to a notable decrease in heart-related hospital admissions. These findings further support the growing role of CGM in not only improving glycemic control but also in promoting broader cardiometabolic health outcomes.
New data from recent studies reveal a 78% reduction in cardiovascular disease-related hospitalizations for individuals with Type 1 diabetes who have experienced prior severe low blood sugar episodes. This significant improvement is linked to the use of Libre biowearable technology, which demonstrates clear advantages over traditional blood glucose monitors in managing cardiovascular health. Additionally, the results show a similar reduction in hospitalizations for cardiovascular complications among adults with Type 2 diabetes who are on insulin and using Libre technology. These findings highlight the potential of continuous glucose monitoring in not only managing blood glucose levels but also reducing the risks of severe cardiovascular outcomes.
“These results are remarkable, as we see dual benefits from CGM technology in managing diabetes and its associated cardiovascular complications,” said one of the lead authors of the studies, David Nathanson, MD, PhD, Karolinska University Hospital in Sweden. “CGMs empower people to proactively manage their diabetes and make informed health choices through real-time, constant feedback on their glucose levels. This data shows that using CGMs is linked with significantly reduced hospitalizations related to heart issues, which can have a significant impact on patients, their families, and the healthcare system by easing medical, emotional, and financial burdens.”
“I regularly treat people with diabetes who have problems with their blood vessels, resulting in heart attacks, strokes, and amputations,” said Ramzi Ajjan, M.D., professor of Metabolic Medicine at the University of Leeds and Leeds Teaching Hospitals NHS Trust. “These blood vessel problems, known collectively as cardiovascular disease, remain the main causes of ill health and death in people with diabetes. I am very excited to see data that show a significant reduction in cardiovascular disease-related hospital admissions. It’s great to see the clear, positive impact of FreeStyle Libre technology on cardiovascular outcomes, making diabetes management more effective and improving the health of our patients.”
The REFLECT studies, funded by Abbott, were real-world retrospective studies that utilized data from the Swedish National Diabetes Register (NDR), one of the largest and most comprehensive diabetes registers globally, representing approximately 90% of all patients with diabetes in Sweden. These studies examined several key outcomes: first, they assessed the impact of intermittently scanned continuous glucose monitoring (CGM) versus traditional blood glucose monitoring on HbA1c levels and hospitalization rates in adults with insulin-treated Type 2 diabetes. Second, the studies analyzed the impact of intermittently scanned CGM compared to blood glucose monitoring on hospitalization rates for metabolic and vascular complications, as well as HbA1c levels, in adults with Type 1 diabetes. Lastly, the studies explored the risk of cardiovascular complications following severe hypoglycemia in adults with Type 1 diabetes, comparing the risk of post-severe hypoglycemia cardiovascular complications in users of intermittently scanned CGM versus those using traditional blood glucose monitoring.
As per DelveInsight’s “Blood Glucose Monitoring Systems Market Report”, the global blood glucose monitoring systems market was valued at USD 12.12 billion in 2024, growing at a CAGR of 7.72% during the forecast period from 2024 to 2030 to reach USD 18.89 billion by 2030. The blood glucose monitoring systems market is expanding rapidly due to the rising prevalence of lifestyle style disorders such as diabetes and impaired glucose tolerance, growing product launches and approvals by key players, and a rising preference for minimally invasive techniques that are expected to significantly drive the demand for blood glucose monitoring systems from 2024 to 2030.
Philips Launched RADIQAL Clinical Study to Validate Ultra-Low X-ray Dose Technology Aiming to Reduce Radiation Exposure in Coronary Procedures Without Compromising Performance
On May 20, 2025, Philips, a global leader in health technology, announced the launch of the RADIQAL (Radiation Dose and Image Quality Trial), a multicenter, randomized study aimed at improving diagnostic imaging in coronary artery disease (CAD) patients. Sponsored by Philips, the trial will enroll 824 patients across six hospitals in Spain, the Czech Republic, and the United States. The study’s objective is to evaluate the impact of advanced imaging technologies on radiation dose and image quality in CAD patients. The first patient in the study was enrolled at Aarhus University Hospital in Denmark, marking the beginning of this important clinical research initiative.
This prospective, randomized, unblinded, comparative, international, multi-center clinical investigation will enroll 824 patients across six hospitals in Spain, the Czech Republic, Denmark, and the United States. The primary objective of the study is to demonstrate that the new technology can effectively reduce overall patient radiation dose while maintaining the performance of coronary procedures. This investigation aims to provide critical insights into the balance between minimizing radiation exposure and ensuring optimal procedure outcomes for patients with coronary artery disease.
“The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology,” said Dr. Javier Escaned, Professor of Cardiology at Hospital Clínico San Carlos and principal investigator. “It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultra-low contrast procedures. RADIQAL is designed to generate robust, real-world evidence on whether Philips’ new ultra-low X-ray dose technology can reduce radiation exposure for patients and staff without affecting the quality of coronary procedures.”
“Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,” said Dr. Darshan Doshi, Head of Medical & Clinical at Philips Image-Guided Therapy Devices and Interventional Cardiologist at the Massachusetts General Hospital in Boston, USA. “Interventional cardiologists rely on low-dose, high-quality imaging for confident decision-making throughout multiple procedures each day. Also for patients, especially those with high BMI or with complex conditions requiring repeat interventions, minimizing radiation exposure is increasingly critical.”
The RADIQAL trial evaluates the radiation exposure, image quality, and procedural performance between Philips’ new ultra-low dose technology and the existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol for coronary procedures, reducing X-ray exposure by 50% compared to even the lowest setting available on current Azurion systems with ClarityIQ. This advancement already received CE marking and is cleared under the EU MDR regulatory framework, ensuring its compliance and safety for use in clinical settings.
According to DelveInsight’s “X-Ray Devices Market Report”, the global X-ray devices market was valued at USD 9.75 billion in 2024, growing at a CAGR of 8.36% during the forecast period from 2024 to 2030 to reach USD 15.70 billion by 2030. The X-ray devices market is experiencing significant growth due to the rising prevalence of chronic disorders such as cardiovascular disorders and different types of cancer, increasing instances of dental disorders including periodontal diseases and tooth decay, coupled with rising product developmental activities that are acting as major factors contributing to the overall growth of the X-ray devices market during the forecast period from 2024 to 2030.
GE HealthCare Launched CleaRecon DL, Introducing AI-Powered 3D Reconstruction to Revolutionize Interventional Suite and Enhance Clinical and Operational Outcomes
On May 15, 2025, GE HealthCare announced the launch of CleaRecon DL, a cutting-edge technology powered by a deep-learning algorithm aimed at enhancing the quality of cone-beam computed tomography (CBCT) images. This AI-driven solution is specifically designed to eliminate streak artifacts caused by the pulsatile nature of blood flow in the arteries and variations in contrast distribution during CBCT acquisitions. It is particularly useful in liver, prostate, neuro, and endovascular aortic repair procedures. CleaRecon DL recently received U.S. FDA 510(k) clearance and CE mark, confirming its safety and efficacy. The technology will be available for use on the Allia™ platform, further expanding its capabilities in advanced imaging solutions.
“The introduction of CleaRecon DL represents a leap forward in the interventional suite and for the advancement of CBCT. By improving image quality and reducing artifacts, this technology can empower clinicians to perform procedures with greater precision and confidence,” said Arnaud Marie, General Manager, Interventional Solutions at GE HealthCare. “This solution builds on our portfolio of tools aimed at improving the user experience and workflow efficiency, enabling clinicians to deliver more accurate and effective interventions for enhanced patient outcomes.”
“CleaRecon DL takes CBCT to the next level, enabling clinicians to confidently use CBCT on patients with tools that help us provide the highest quality imaging and treatment across a wide range of clinical scenarios,” said. Dr. Charles Nutting5, Interventional Radiologist, Image Guided Therapy in Denver, Colorado. “This advancement improves our ability to perform precise interventions, with less manipulation of the image and eliminates artifacts that have historically hindered image clarity, ultimately helping improve the care clinicians can provide to patients.”
Cone-beam computed tomography (CBCT) is widely used in interventional suites to provide cross-sectional imaging during various procedures. However, the quality of CBCT reconstructed images can be compromised by artifacts caused by the pulsatility of blood vessels, which can reduce both image clarity and accuracy. These artifacts may diminish the confidence clinicians have in interpreting CBCT images, posing a challenge to its broader adoption in routine clinical practice. Despite these limitations, CBCT remains an essential tool in interventional procedures, offering comprehensive visualization of anatomical structures and significantly enhancing procedural accuracy.
Deep learning is an advanced AI technology that become the state-of-the-art approach for image processing, enabling machines to learn from data and perform specific tasks. It relies on population-representative data and extensive testing in collaboration with clinical domain experts to ensure its effectiveness. CleaRecon DL leverages deep-learning algorithms designed to deliver clearer and more accurate imaging, empowering healthcare professionals to make better-informed decisions and enhance patient care. During clinical validation testing, a recent survey found that 98% of cases showed CBCT images reconstructed with CleaRecon DL were clearer than conventional CBCT images. Moreover, this technology was shown to increase confidence in CBCT image interpretation in 94% of cases, highlighting its significant impact on improving diagnostic accuracy and clinical outcomes.
According to DelveInsight’s “Computed Tomography (CT) Devices Market Report”, the global computed tomography devices market was valued at USD 8,400.69 million in 2024, growing at a CAGR of 6.15% during the forecast period from 2025 to 2032 to reach USD 13,460.21 million by 2032. The rising prevalence of chronic diseases, such as cancer, cardiovascular disorders, and respiratory illnesses, significantly increases the demand for diagnostic imaging, making computed tomography (CT) devices essential for early detection and monitoring. Additionally, technological advancements, including faster scanning speeds, enhanced image resolution, and lower radiation exposure, make CT devices more efficient and safer, encouraging wider adoption by healthcare providers. Furthermore, key market players are continuously developing innovative products, such as portable and AI-integrated CT systems, which improve diagnostic accuracy and expand the application of CT devices in various medical fields. Collectively, these factors are expected to boost the market for computed tomography devices during the forecast period from 2025 to 2032.
Philips Launched Real-Time 3D Intracardiac Imaging Catheter in Europe, Advancing Minimally Invasive Heart Procedures and Enhancing Patient-Centered Care for Structural Heart Disease
On May 19, 2025, Philips, a global leader in health technology, announced the launch of its VeriSight Pro 3D Intracardiac Echocardiography (ICE) catheter in Europe. Building on its successful introduction in the United States, VeriSight Pro offers real-time 3D imaging directly inside the heart, providing physicians with enhanced clarity during procedures. This advanced technology allows for more precise interventions, all while eliminating the need for general anesthesia, offering both clinical and patient benefits.
The VeriSight Pro 3D ICE catheter is a pioneering innovation featuring a miniaturized ultrasound probe embedded at the tip of a thin, steerable catheter. This catheter is carefully navigated through the vascular system into the heart chambers, providing high-quality 2D and 3D images in real-time. The technology offers enhanced procedural guidance, enabling more precise and efficient interventions. Crucially, it supports patient-friendly care by eliminating the need for general anesthesia, making it an ideal solution for structural heart disease treatments. Designed for complex procedures such as transcatheter valve repair and left atrial appendage closure, the VeriSight Pro 3D ICE catheter provides high-resolution 2D and 3D visualization directly within the heart chambers. This advanced imaging capability enhances clinical decision-making during structural heart and electrophysiology interventions, allowing physicians to perform procedures with greater confidence and precision. Additionally, by eliminating the need for general anesthesia and its associated risks, VeriSight Pro offers a more patient-friendly approach to heart procedures.
“With VeriSight Pro 3D ICE, we now have the ability to see detailed cardiac anatomy from inside the heart in real time,” said Prof. Dr. Jörg Hausleiter, Ludwig-Maximilians-Universität (LMU) Munich, Germany. “This helps streamline our workflows and makes complex procedures more accessible to patients who may not tolerate more invasive imaging approaches.”
“VeriSight Pro reflects our ongoing commitment to delivering clinically relevant innovations that enhance precision, reduce procedure complexity, and improve the care experience,” said Stacy Beske, Business Leader of Image-Guided Therapy Devices at Philips. “Its availability in Europe is an important milestone in helping more patients benefit from image-guided, minimally invasive heart procedures, while supporting care teams with integrated solutions that adapt to the way they work.”
VeriSight Pro is a pioneering innovation featuring a miniaturized ultrasound probe approximately 3 millimeters in diameter, embedded at the tip of a thin, steerable catheter. This compact device is designed to be navigated through the vascular system and into the heart chambers, providing high-quality 2D and 3D real-time imaging. By imaging the heart from within and offering control over the scan angle, VeriSight Pro introduces entirely new possibilities for guiding structural heart interventions. Physicians can now assess anatomy, guide device placement, and confirm procedural results — all from a single access point, avoiding the need for more invasive imaging techniques. As the first ICE catheter to miniaturize the same 3D imaging technology used in transesophageal echocardiography (TEE), VeriSight Pro helps overcome key barriers in delivering efficient, scalable care. This includes enhancing patient tolerance and optimizing resource availability in interventional suites, further improving both procedural outcomes and patient experience.
According to DelveInsight’s “Intracardiac Echocardiography Devices Market Report”, the global intracardiac echocardiography devices market is estimated to grow at a CAGR of 5.33% during the forecast period from 2025 to 2032. The demand for intracardiac echocardiography devices is primarily being boosted by the increasing prevalence of arrhythmia, atrial septal defects, and other cardiovascular diseases. Further, the rising figures of elderly patients, rising demand for minimally invasive approaches, increasing lifestyle disorders, and technological innovations about cardiac-related devices, among others, are thereby contributing to the overall growth of the intracardiac echocardiography devices market during the forecast period from 2025 to 2032.
