GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection

GE HealthCare Announced the U.S. FDA 510(k) Clearance and CE Mark for Allia Moveo and marks first Global Installation, Advancing Precision Care in the Interventional Suite

On February 02, 2026, GE HealthCare announced that Allia™ Moveo received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Marking, marking a significant advancement in mobility and precision within the interventional suite. The latest addition to the Allia platform, first introduced at the Radiological Society of North America (RSNA) 2025 Annual Meeting, was designed to support clinicians across a broad range of cardiovascular, vascular, non-vascular, interventional, and surgical procedures. Allia Moveo enhanced procedural workflows through a compact, cable-free C-arm system featuring an intuitive user interface and AI-powered guidance tools, enabling clinicians to work more efficiently while adapting to the space limitations of conventional interventional suites.

Hôpital Marie-Lannelongue in France, a recognized center of excellence in thoracic, vascular, and cardiac surgery and a national reference site for complex aortic pathologies, became the first medical center globally to complete the installation of Allia Moveo. The platform was designed to enable flexible cone-beam computed tomography (CBCT) and support the hospital in treating vascular and cardiology diseases. The ergonomic, highly maneuverable system was tailored to accommodate a wider patient population, regardless of body size or weight, featuring a wide-bore design and smooth table panning to help care teams maintain comfort, accessibility, and procedural efficiency.

As interventional procedures became increasingly complex, clinicians required imaging solutions that delivered clear insights while optimizing workflows. In minimally invasive interventions involving multiple users, procedural confidence depended on advanced imaging systems that could be positioned quickly and easily, deliver high-quality images, integrate seamlessly with other technologies, and operate at noise levels comparable to normal conversation. Allia Moveo was developed in collaboration with clinicians to address these demands, offering a high-performance, user-friendly system designed to enhance procedural fluidity in space-constrained environments.

The system was equipped with advanced 3D imaging capabilities to support confident anatomical visualization and informed clinical decision-making. These included CleaRecon DLi, an AI-driven technology designed to reduce streak artifacts caused by pulsatile blood flow; Motion Freeze, which helped compensate for involuntary respiratory motion to improve image clarity; and Metallic Artifact Reduction, intended to reveal anatomical details obscured by metal artifacts. In addition, Allia Moveo incorporated augmented guidance solutions, including the ASSIST advanced clinical applications portfolio, which provides enhanced support for complex procedures and is compatible with other GE HealthCare and third-party systems.

“My initial experience with Allia Moveo has been incredible; it’s a real game changer. With Allia Moveo, we had this opportunity to position the system very quickly in any working position that will adapt the best to us,” said Stephan Haulon, M.D., Ph.D., Vascular Surgeon, Head of Aortic Center and Vascular Surgery, Hôpital Marie-Lannelongue (Le Plessis-Robinson), part of the Fondation Hôpital Saint-Joseph, Paris, France. “One of the major milestones of this new system is having access to the reconstruction of the cone beam CT with CleaRecon DL, which is AI-driven and gives you much better image quality.”

According to DelveInsight’s “Diagnostic Imaging Equipment Market Report,” the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023 and is projected to grow at a CAGR of 5.10% from 2024 to 2030, reaching USD 33.56 billion by 2030. The demand for Diagnostic Imaging Equipment is primarily driven by technological advancements, the growing burden of chronic diseases, rising patient awareness of early-stage diagnosis, the need for effective & efficient imaging technologies, and the aging population.

China NMPA Approved the Promega MSI Detection Kit as Companion Diagnostic for KEYTRUDA® 

On February 03, 2026, the National Medical Products Administration (NMPA) approved the OncoMate® Microsatellite Instability (MSI) Detection Kit as a Class III in vitro diagnostic medical device in China. The assay was authorized for use as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) solid tumors who were eligible for treatment with KEYTRUDA® (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 immunotherapy. This approval marked the first Promega companion diagnostic to receive authorization from the NMPA.

Commenting on the milestone, Alok Sharma, Global Clinical Market Director at Promega, said the approval marked progress toward more personalized and effective cancer care in China. He noted that Promega’s collaboration with pharmaceutical partners aimed to deliver global diagnostic solutions that expanded patient access to innovative technologies and life-saving therapies.

China continued to experience one of the highest cancer burdens worldwide, with solid tumors accounting for the majority of diagnoses. Despite ongoing advances in oncology care, many patients with advanced solid tumors eventually progress following first-line therapy, underscoring the need for diagnostic tools capable of guiding alternative and more effective treatment strategies. The OncoMate® MSI Detection Kit, a PCR-based assay, was developed to assess MSI status in tumor tissue, supporting precision oncology approaches and informing treatment decisions in solid tumors.

The NMPA approval was supported by a collaboration between Promega and Merck & Co., Inc., Rahway, NJ, USA, the company that markets KEYTRUDA. The partnership reflected a shared commitment to improving access to companion diagnostics, enabling informed therapeutic decision-making.

Promega’s MSI technology had also received regulatory approvals in China, the European Union, and the United States. Additionally, the OncoMate® MSI Dx Analysis System was recently approved by the U.S. FDA as a companion diagnostic to identify patients with microsatellite-stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA in combination with LENVIMA® (lenvatinib), a multikinase tyrosine kinase inhibitor developed by Eisai. Following regulatory clearance, the OncoMate® MSI Detection Kit was expected to become commercially available in China.

“This approval represents a step toward more personalized and effective cancer treatment in China,” says Alok Sharma, Global Clinical Market Director at Promega. “We are proud to collaborate with pharmaceutical companies to deliver global solutions that expand access to innovative technologies and life-saving, effective therapies.”

As per DelveInsight’s “Companion Diagnostics Market Report,” the global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The growth in the market for companion diagnostics is primarily driven by the exponential rise in cancer cases worldwide. Additionally, rising awareness of precision medicine among patients, along with manufacturers’ growing focus on its development, has bolstered demand for companion diagnostics. Furthermore, increased research and development of companion diagnostics for non-cancer disorders, along with growing approvals and launches of companion diagnostic products, are key factors expected to drive the global companion diagnostics market over the forecast period 2024 to 2030.

Oracle Life Sciences AI Data Platform United Data and Agentic Intelligence to Accelerate Medical Breakthroughs and Drive Commercial Success 

On January 29, 2026, Oracle announced the launch of the Oracle Life Sciences AI Data Platform, a generative AI–enabled solution developed to help pharmaceutical, medical device, research, and life sciences organizations accelerate outcomes across research and development, clinical trials, post-market safety, and commercialization.

The platform was designed to unlock insights at scale by providing a foundation for AI-powered research and unifying and automating large, complex datasets. It combined customer data, third-party information, and more than 129 million de-identified longitudinal Oracle Health real-world data records, enabling organizations to manage and analyze diverse data sources within a single environment. Generative AI and agentic reasoning were applied to accelerate data interpretation and deliver actionable evidence directly within research and clinical workflows.

Powered by preconfigured AI agents as well as the ability for users to build custom agents, the platform enabled organizations to identify label expansion opportunities, conduct population-level health economics and outcomes research (HEOR), generate synthetic control arms, monitor safety signals across disparate data sources, and support regulatory submissions with improved efficiency and adaptability. Researchers were also able to ask open-ended questions, with AI agents clarifying user intent, generating and refining hypotheses, proposing analyses for review, and executing tasks within predefined guardrails while maintaining full transparency into data lineage.

By automating complex analytical processes, the platform enabled the scaling of research teams, helped uncover new clinical and commercial opportunities, maximized the value of existing therapies, and delivered measurable business outcomes.

Each new Oracle Life Sciences innovation was designed to integrate seamlessly into the unified data platform. The solution leveraged Oracle Cloud Infrastructure (OCI), the Oracle Life Sciences AI Application Suite, Oracle Fusion Cloud Supply Chain Management (SCM), Oracle Fusion Cloud Sales, and the Oracle Health AI Application Suite, enabling life sciences organizations to benefit from a fully interoperable and end-to-end Oracle ecosystem.

“Fragmented, inconsistent data is a major barrier to progress, holding back life sciences organizations from delivering the medical breakthroughs that could transform and even save lives,” said Seema Verma, executive vice president and general manager, Oracle Health and Life Sciences. “Oracle Life Sciences AI Data Platform unifies and intelligently organizes data and employs AI and advanced analytics to reveal deep insights that are often not possible with humans alone.”

As per DelveInsight’s “Real-World Evidence Solution Market Report,” the global real-world evidence solution market was valued at USD 2,832.33 million in 2024, growing at a CAGR of 8.07% during the forecast period from 2025 to 2032 to reach USD 5,240.07 million by 2032. The market for real-world evidence solutions is primarily driven by the growing prevalence of chronic diseases and their impact on the real-world market. Additionally, increasing technological innovations in big data analytics, machine learning, and artificial intelligence enable the efficient processing and analysis of vast amounts of real-world data. Furthermore, the increasing application of real-world evidence solutions in the pharmaceutical and biotech industries aims to enhance drug development, support regulatory approvals, secure market access, and monitor post-market performance. Overall, these factors are expected to drive market growth for real-world evidence solutions over the forecast period from 2025 to 2032.

Quest Diagnostics Launched Novel Flow Cytometry MRD Blood Test for Myeloma, Enabling Ultrasensitive Detection of Residual Disease 

On February 02, 2026, Quest Diagnostics, a major provider of diagnostic information services, announced the introduction of a new blood-based test that leverages advanced flow cytometry to evaluate measurable residual disease (MRD) in patients with multiple myeloma, a blood cancer. The assay, named Quest Flow Cytometry MRD for Myeloma, delivered sensitivity comparable to next-generation sequencing (NGS) methods for detecting residual myeloma, while offering a significantly lower-cost alternative that supported improved patient care and clinical outcomes.

The test differentiated itself by using next-generation flow cytometry on noninvasive blood samples rather than bone marrow aspirates, which were typically required for NGS-based MRD testing. Unlike sequencing approaches that depended on a pretreatment baseline aspirate for longitudinal monitoring, the Quest assay could be used even when no baseline sample was available. Additionally, the test demonstrated five-day specimen stability, exceeding the three-day or shorter stability typically associated with conventional flow cytometry, thereby improving accessibility when sample transport to the laboratory required additional time.

According to Timothy Looney, PhD, Senior Director of Immuno-Oncology at Quest Diagnostics, the strong interest shown by clinicians at the recent American Society of Hematology (ASH) Annual Meeting and Exposition underscored the assay’s potential to significantly enhance the multiple myeloma treatment paradigm. He noted that the combination of high sensitivity, lower cost, and extended sample stability provided tangible benefits to both patients and care teams managing this challenging disease.

Beyond its role in routine clinical care, the Quest Flow Cytometry MRD for Myeloma test was expected to serve as a valuable tool for monitoring responses in clinical trials. In January 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance supporting the use of MRD as a primary endpoint in clinical trials evaluating drug and biological products for the treatment of multiple myeloma, reinforcing the relevance of such assays in drug development and regulatory decision-making.

Quest Diagnostics continued to expand its oncology testing portfolio and remained a leading provider of advanced cancer diagnostics, including the Haystack MRD® test for residual disease assessment in solid tumors. The launch of the new myeloma-focused MRD assay further complements Quest’s comprehensive offerings in hematopathology and molecular oncology, strengthening its ability to support better patient outcomes.

“Our Flow Cytometry MRD for Myeloma test harnesses cutting-edge science and technology to deliver ultrasensitive insights from a noninvasive blood test, thereby improving care and value for patients and the healthcare system,” said board-certified oncologist and hematologist Yuri Fesko, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. “This new test merges this elite performance with improved access, given Quest’s approximately 7,000 phlebotomy sites across the United States, helping to illuminate a path to better health for more patients.”

According to DelveInsight’s “Minimal Residual Disease Testing Market Report”, the minimal residual disease testing market was valued at USD 2,031.45 million in 2024, growing at a CAGR of 10.61% during the forecast period from 2025 to 2032 to reach USD 4,514.74 million by 2032. The growing demand for minimal residual disease (MRD) testing is primarily fueled by the rising incidence of solid tumors and hematologic malignancies such as leukemia, multiple myeloma, and lymphoma. Advancements in molecular diagnostic technologies have significantly improved MRD detection accuracy, and ongoing product development and launch activities by key market players continue to strengthen market dynamics. Collectively, these factors are expected to drive robust, sustained growth in the MRD testing market over the forecast period from 2025 to 2032.

FDA Greenlights RevBio’s Pivotal Clinical Trial for its Cranial Flap Bone Glue 

On January 28, 2026, RevBio, Inc. announced that it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a multicenter, randomized, controlled pivotal clinical trial evaluating TETRANITE® for the reintegration of cranial bone flap sections of the skull temporarily removed during neurosurgical procedures.

The study was designed to demonstrate that TETRANITE could immediately stabilize cranial flaps and promote bone fusion in both craniotomy and cranioplasty procedures, with the goals of improving cosmetic outcomes, enhancing flap stability for patient comfort, and reducing the risk of cerebrospinal fluid (CSF) leaks. These complications represented well-recognized limitations of the existing standard of care, which relied on titanium plate-and-screw fixation systems.

Known as the T-RESTORE II trial, the pivotal study was planned to enroll up to 204 patients, with participants randomized to receive either TETRANITE or conventional cranial plate-and-screw fixation to secure bone flaps. Craniotomy procedures were commonly performed to remove brain tumors, treat aneurysms, relieve elevated intracranial pressure, or enable deep-brain stimulation. During these procedures, surgeons created a kerf line, a continuous gap between the removed bone flap and the surrounding skull. Although the bone flap was repositioned and secured during surgical closure, the kerf line typically remained unfilled, limiting bone integration because the gap exceeded the distance bone cells could naturally bridge.

As a regenerative bone adhesive applied directly into the kerf, TETRANITE was intended to immediately fix the bone flap in the correct anatomical position, seal the gap, and create a biological pathway that enabled bone cells to migrate from the surrounding skull. This process supported bone fusion and solid healing of the cranial flap.

The FDA approved up to 15 clinical sites to participate in the trial. At the time of approval, RevBio was actively recruiting study sites in accordance with guidance from its neurosurgical advisory board. The IDE approval was primarily supported by positive outcomes from a pivotal preclinical study, successful surgeon handling evaluations, and favorable results from the company’s pilot clinical study, T-RESTORE I.

“This novel regenerative adhesive has the potential to change how cranial restoration procedures are performed and significantly improve outcomes for patients,” said Timothy R. Smith, MD, PhD, MPH, Director, Computational Neuroscience Outcomes Center and practicing neurosurgeon at Brigham and Women’s Hospital in Boston, Massachusetts.

According to DelveInsight’s ”Cranial Fixation System Market Report,” the cranial fixation system market was valued at USD 1.56 billion in 2023, growing at a CAGR of 8.48% during the forecast period from 2024 to 2030 to reach USD 2.54 billion by 2030. The cranial fixation system market is growing significantly due to the high incidence of traumatic brain injuries from motor vehicle accidents, and sports, the considerable prevalence of fractures, rising product developmental activities by key players, availability of a wide range of cranial fixation systems, among others that are expected to drive the market for cranial fixation system during the forecast period from 2024 to 2030.

Hyperfine Announced the Publication of Breakthrough Clinical Data Demonstrating the Swoop® System’s Enhanced Stroke Detection Capabilities 

On January 27, 2026, Hyperfine, Inc., a health technology company recognized for introducing the first FDA-cleared, AI-powered portable MRI system for brain imaging, reported results from the largest dataset to date assessing the use of the Swoop® system for stroke detection. The findings provided strong clinical evidence supporting the application of AI-enabled portable MRI for stroke identification across multiple care settings, including hospital emergency departments.

The prospective, multicenter observational study, published in the November issue of Stroke: Vascular and Interventional Neurology (SVIN), analyzed data from 95 patients. The dataset combined results from the ACTION PMR study conducted at Massachusetts General Hospital and Buffalo General Medical Center, along with additional patient data from Yale New Haven Hospital. The study assessed the sensitivity and specificity of ischemic lesion detection, compared performance between the original and next-generation Swoop® MRI systems, and evaluated two diffusion-weighted imaging (DWI) sequences, which are critical for accurate stroke diagnosis.

Results demonstrated that the advanced multidirectional DWI sequence available on the next-generation Swoop® system delivered substantial improvements in diagnostic performance compared with the original scanner. The updated system successfully detected ischemic lesions as small as 2.8 mm (0.15 mL), enabling identification of very small strokes that might otherwise go undetected. For clinically significant lesions larger than 1.0 mL, the system achieved 100% sensitivity and 100% specificity, indicating perfect diagnostic accuracy within this range.

In addition, the next-generation Swoop® system reduced scan times by approximately 30%, making rapid stroke imaging more feasible in time-sensitive emergency care environments. The system also demonstrated improved image uniformity across the brain, enhancing image quality and increasing diagnostic confidence among clinicians.

“Stroke detection represents a critical driver of the Swoop® system’s expansion into emergency departments,” commented Maria Sainz, President and CEO of Hyperfine. “The results from our next-generation Swoop® system, combined with our new, advanced multi-direction DWI sequence that was recently cleared by the FDA, are truly remarkable. This data gives us even greater confidence that the Swoop® system can reliably detect clinically relevant strokes, streamline workflows, and further strengthen the value of integrating portable MRI into stroke diagnosis and care.”

According to DelveInsight’s “Magnetic Resonance Imaging (MRI) Devices Market Report”, the magnetic resonance imaging devices market was valued at USD 8,207.06 million in 2024, growing at a CAGR of 6.54% during the forecast period from 2025 to 2032 to reach USD 13,553.33 million by 2032. The rising prevalence of various chronic disorders, such as cardiovascular diseases, cancer, and neurological conditions, is fueling the demand for precise diagnostic tools like MRI, which offers superior imaging capabilities for soft tissues and organs. Additionally, the increasing awareness and the emphasis on early diagnosis of chronic disease are encouraging patients and healthcare providers to adopt MRI for timely intervention. Furthermore, technological advancements are driving growth in the MRI market, with innovations such as high-field and open MRI systems, functional MRI (fMRI), and shorter scan times improving imaging accuracy, comfort, and efficiency. Collectively, these factors are expected to increase global demand for magnetic resonance imaging devices over the forecast period from 2025 to 2032.