Philips Secures FDA Nod for Image-Guided Platform in Prostate Cancer Treatment; Roche Gains CE Mark for Alzheimer’s Screening Blood Test; CorTec Completes First Human Implantation of Its Brain-Computer Interface in Neurotech Breakthrough; Natera Initiates ABCSG 61 Trial to Assess Signatera™ in Early-Stage Breast Cancer; GE HealthCare Introduces Advanced Digital X-ray System to Enhance Imaging Accessibility in High-Volume Settings; Stryker-Owned Inari Medical Launches InThrill® System for AV-Access and Small Vessel Thrombus Treatment

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Philips Secures FDA Nod for Image-Guided Platform in Prostate Cancer Treatment; Roche Gains CE Mark for Alzheimer’s Screening Blood Test; CorTec Completes First Human Implantation of Its Brain-Computer Interface in Neurotech Breakthrough; Natera Initiates ABCSG 61 Trial to Assess Signatera™ in Early-Stage Breast Cancer; GE HealthCare Introduces Advanced Digital X-ray System to Enhance Imaging Accessibility in High-Volume Settings; Stryker-Owned Inari Medical Launches InThrill® System for AV-Access and Small Vessel Thrombus Treatment

Jul 31, 2025

Philips Secured FDA 510(k) Clearance for Image-Guided Navigation Technology, Advancing Minimally Invasive Prostate Cancer Treatment 

On July 23, 2025, Philips, a global leader in health technology, announced a significant milestone in prostate cancer care with the U.S. FDA 510(k) clearance of the latest version of its Philips UroNav system. This next-generation image-guided navigation platform introduces an advanced annotation workflow designed to support clinicians during focal therapy procedures, enabling greater precision and enhanced minimally invasive treatment. The enhanced UroNav system reflects Philips’ commitment to innovation in personalized cancer care, helping to improve diagnostic accuracy and procedural confidence while reducing patient burden.

“We’re entering a new era of precision prostate cancer care. Philips’ integrated focal therapy platform unifies imaging, biopsy pathology, treatment planning, and 3D imaging guidance with MR US fusio,n giving clinicians end-to-end efficiency and control,” said Dr. Ardeshir Rastinehad, Vice Chair of Urology at Lenox Hill Hospital and System Director of Prostate Cancer at Northwell Health. “With fused imaging and real-time ablation guidance in one place, we can personalize therapy with greater accuracy and spare patients the unnecessary side effects of traditional treatments.”

“We’re helping clinicians deliver more precise prostate cancer care by streamlining complex workflows and delivering the insights they need to support precise diagnosis and expand options for minimally invasive treatments,” said Martijn Hartjes, Business Leader, Clinical Informatics at Philips. “Our goal is to equip clinicians with the clinical tools required so they can deliver better care for more patients.”

As an advanced image fusion system, Philips UroNav seamlessly integrates pre-procedural imaging, such as Magnetic Resonance Imaging (MRI), with real-time intra-procedural ultrasound (US) imaging. This innovative combination empowers clinicians with a comprehensive and dynamic view of the prostate, significantly enhancing the precision and accuracy of diagnostic and therapeutic procedures.

By enabling a more targeted approach, UroNav supports more informed treatment selection. Patients benefit from more precise, personalized care, while clinicians are equipped to make better diagnostic decisions. Fusion biopsy using systems like UroNav demonstrated a 30% improvement in the detection of high-risk prostate cancer compared to standard biopsy methods. The latest UroNav version also features a new advanced annotation workflow, designed to work in tandem with DynaCAD Urology. This enhancement streamlines the planning, delivery, and review of focal therapy procedures, reducing workflow complexity and enabling a broader group of clinicians to offer minimally invasive treatment options with greater confidence.

As per DelveInsight’s “Surgical Navigation Systems Market Report”, the global surgical navigation systems market was valued at USD 7,753.34 million in 2023, growing at a CAGR of 6.76% during the forecast period from 2024 to 2030. The demand for surgical navigation systems is primarily being boosted by the increasing prevalence of various chronic diseases such as stroke, Alzheimer’s, cerebrovascular disease, and others. Further, the rising incidences of orthopedic disorders, especially among the geriatric population, along with increasing demand for minimally invasive surgical procedures, and growing activities for research and development for surgical navigation systems are thereby contributing to the overall growth of the surgical navigation systems market during the forecast period from 2024-2030.

Roche Secured CE Mark for Minimally Invasive Blood Test to Help Rule Out Alzheimer’s Disease 

On July 23, 2025, Roche announced that its Elecsys® pTau181 test has received CE Mark under the In Vitro Diagnostic Regulation (IVDR), making it the first certified blood-based test designed to rule out Alzheimer’s-associated amyloid pathology. Developed in collaboration with Eli Lilly and Company, the test measures phosphorylated Tau (pTau) 181, a key biomarker linked to amyloid pathology, one of the defining features of Alzheimer’s disease. 

Clinicians can use Elecsys pTau181 alongside other clinical assessments to help determine whether Alzheimer’s is not the underlying cause of cognitive decline. A negative result may eliminate the need for further confirmatory testing, streamlining the diagnostic process and potentially reducing patient burden. This minimally invasive blood test has shown strong clinical utility in primary care settings across patients presenting with varying degrees of cognitive impairment.

“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics. “With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.”

Clinical study findings support that the Elecsys® pTau181 test can be effectively integrated across a range of care settings, including primary care, where most individuals first seek help for cognitive symptoms. By identifying patients who are unlikely to have Alzheimer’s-related amyloid pathology, the test helps avoid unnecessary follow-up procedures. Those with positive results can be referred for further diagnostic evaluation, enabling earlier detection of Alzheimer’s disease—a critical step for accessing emerging treatments that are most beneficial in the early stages. Early identification also empowers patients and families to make informed decisions about their care and future planning.

In parallel, Roche is developing the Elecsys® pTau217 blood test, an in-vitro diagnostic immunoassay designed to quantitatively measure phospho-Tau (217P) in human plasma as an aid in detecting amyloid pathology. Recent data presented on the Elecsys pTau217 assay showed it can accurately identify amyloid pathology and offers greater stability than the pTau217/Aβ42 ratio in both blood and plasma samples stored at room or refrigerator temperatures. With its high throughput capability, full automation, and compatibility with Roche’s extensive installed base of analyzers, the Elecsys pTau217 test holds strong potential as a scalable and reliable standalone diagnostic tool for widespread use in routine clinical practice worldwide.

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 the rise in 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 for 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 need 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.

CorTec Marked Neurotech Breakthrough with First Human Implantation of Germany‑Made Brain Computer Interface 

On July 29, 2025, CorTec GmbH, a trailblazer in active implantable medical technologies, announced the successful first human implantation of its proprietary Brain Interchange™ brain-computer interface (BCI) system. This milestone represents a significant leap in bridging laboratory innovation with real-world clinical applications. The procedure was performed in late July at Harborview Medical Center in Seattle under an FDA Investigational Device Exemption (IDE).

The trial is led by Principal Investigator Dr. Jeffrey G. Ojemann from the University of Washington School of Medicine and Co-Principal Investigator Professor Steven C. Cramer from the University of California, Los Angeles. The study aims to collect initial safety data and assess whether direct cortical electrical stimulation can effectively enhance upper-limb motor recovery in stroke patients. This groundbreaking research is supported by funding from the National Institutes of Health (NIH).

“We’re thrilled to share that the implantation procedure was a success and, most importantly, the patient is in good condition and recovering well from the surgery. We’re incredibly grateful for this initial outcome in our first study participant. Both the therapeutic strategy and the technology we are using are entirely novel. While we proceed with careful optimism, the potential benefits for patients are promising,” commented Jeffrey G. Ojemann, MD, Vice Chair and Professor of Neurological Surgery, University of Washington School of Medicine.

“The first implantation of our BCI marks a milestone for European medical neurotechnology and underscores CorTec’s emergence as Germany’s first implantable BCI developer, ready to compete on the global stage,” said Dr. Frank Desiere, CEO of CorTec. “Building on our extensive experience in developing advanced components and active implantable systems, our proprietary cutting-edge BCI system is now entering human clinical testing, aiming to help people affected by neurological diseases recover lost function and enhance their quality of life. We are proud of this new era of innovation and are committed to expanding the possibilities of neurotechnology to improve outcomes for patients.”

This innovative approach delivers highly precise and personalized treatment for neurological conditions. The implant system continuously monitors brain activity, instantly interpreting neural signals and providing targeted electrical stimulation in real time to promote neuroplasticity, the brain’s remarkable ability to reorganize and form new neural connections. This study aims to determine whether such targeted stimulation can help the brain relearn lost functions, ultimately accelerating and improving rehabilitation outcomes for patients.

According to DelveInsight’s “Implanted Brain-Computer Interface (BCI) Devices Market Report”, the global implanted brain-computer interface (BCI) devices market is estimated to grow at a CAGR of 10.42% during the forecast period from 2025 to 2032. The demand for implanted brain-computer interface (BCI) devices is significantly driven by the increasing prevalence of neurological and movement disorders and a rising number of patients experiencing hearing and vision loss. Additionally, the growing adoption of digital health solutions is reshaping the landscape of patient care, further fueling market growth. Key factors contributing to this upward trend include increasing research and development activities and strategic collaborations among leading players to develop more advanced BCI devices. These developments are expected to play a pivotal role in propelling the implanted BCI devices market during the forecast period from 2025 to 2032.

Natera Launched ABCSG 61 (“TEODOR”) Randomized Controlled Trial Evaluating Signatera™ in Early‑Stage Breast Cancer 

On July 29, 2025, Natera, Inc., a global leader in cell-free DNA testing and precision medicine, announced the launch of the TEODOR trial (Neoadjuvant TrEatment Optimization driven by ctDNA and endOcrine Responsiveness). TEODOR is a Phase II, multicenter, randomized controlled trial (RCT) designed to explore whether chemotherapy can be safely replaced with endocrine therapy before surgery in a select group of women with hormone receptor-positive (HR+), HER2-negative breast cancer.

The study uses Signatera, Natera’s personalized molecular residual disease (MRD) test, to identify patients who are endocrine-responsive and ctDNA-negative, potential candidates for de-escalation of neoadjuvant chemotherapy. By focusing treatment on individual tumor biology, the TEODOR trial aims to minimize unnecessary toxicity while maintaining clinical outcomes.

“TEODOR is designed to examine whether we can use endocrine responsiveness and ctDNA status to optimize systemic therapy in the neoadjuvant setting,” said ABCSG President, Michael Gnant, M.D., FACS, FEBS, who serves as professor of surgery, Comprehensive Cancer Center, Medical University of Vienna, and principal investigator of the TEODOR trial. “This study marks a critical step toward more personalized medicine, leveraging the latest technologies to improve patient care.”

“With the TEODOR trial, our goal is to identify patients who may be able to safely forgo chemotherapy,” said Angel Rodriguez, M.D., medical director of oncology at Natera. “We are proud to collaborate with ABCSG on this important trial, and we hope this study will support the role of Signatera in guiding neoadjuvant therapy in breast cancer.”

The TEODOR trial, sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), aims to enroll approximately 250 patients across 15 sites in Austria. Prior research has shown that patients who test negative for circulating tumor DNA (ctDNA) using Signatera at diagnosis, and subsequently receive chemotherapy, have an excellent prognosis, with a recurrence risk of less than 5%. To reduce the use of pre-operative chemotherapy and its associated side effects, the TEODOR trial is designed to evaluate whether endocrine therapy alone may be equally effective for Signatera-negative patients with hormone receptor-positive (HR+), HER2-negative breast cancer.

Following an initial four-week course of endocrine therapy, patients who remain Signatera-negative and demonstrate favorable endocrine sensitivity, measured by the Ki-67 proliferation index, will be randomized to receive either continued endocrine therapy or standard chemotherapy before surgery. The primary endpoint of the study is the response to neoadjuvant therapy, assessed by pathological complete response (pCR) and the modified Preoperative Endocrine Prognostic Index (PEPI) score. Secondary endpoints include long-term outcomes such as breast cancer recurrence and overall survival.

According to DelveInsight’s “Molecular Diagnostics Market Report”, the global molecular diagnostics market was valued at USD 9.56 billion in 2024, growing at a CAGR of 9.21% during the forecast period from 2025 to 2032, to reach USD 16.12 billion by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B and Hepatitis C, Influenza, and human papillomavirus (HPV). The introduction of new and innovative products by key Molecular Diagnostics Companies, among others, is expected to drive the molecular diagnostics market from 2025 to 2032.

GE HealthCare Launched Advanced Digital X-ray System to Expand Access to Affordable, High-Quality Imaging in High-Throughput Settings

On July 24, 2025, GE HealthCare announced the commercial launch of Definium™ Pace Select ET, an advanced floor-mounted digital X-ray system designed to deliver high-quality imaging while improving efficiency, affordability, and access, especially in high-demand clinical environments.

The Definium Pace Select ET brings affordable, high-performance imaging to facilities managing large patient volumes. Engineered to function like a personal assistant for technologists, the system automates key in-room workflows and motorizes repetitive manual tasks. This not only helps increase throughput but also reduces the technologist’s learning curve, supporting consistent performance and improving overall workflow efficiency. Building on the trusted Definium platform from GE HealthCare, the Definium Pace Select ET system brings advanced automation and workflow features to a flexible, floor-mounted system with an elevating table, in-room exam control, and a common user interface to assist technologists.

“Burdened with the stress and pressure to keep radiology departments running smoothly and profitably, we aim to empower technologists with a system that consistently makes the first image count,” said Sharad Sharma, Global General Manager, X-ray, at GE HealthCare. “With its advanced digital capabilities and automation, Definium Pace Select ET al allows technologists of all experience levels to deliver consistent high-quality images to serve the full range of anatomies and patient populations.”

“This launch reinforces our commitment to provide accessible, efficient, and high-quality care for patients, while alleviating stress from the technologist’s workday by minimizing repetitive tasks and automating steps,” said Jyoti Gupta, PhD, President & CEO of Women’s Health and X-ray at GE HealthCare. “We remain dedicated to advancing our technology through transformative digital and AI-enabled capabilities that will remove barriers to timely and effective diagnostic imaging for any patient in need of X-ray imaging.”

GE HealthCare’s new Definium™ Pace Select ET addresses key challenges in high-volume imaging environments by automating manual, repetitive tasks and reducing physical strain on technologists. Leveraging AI-driven technologies, the system enhances patient positioning accuracy and delivers consistent, high-quality images across a range of clinical scenarios, all while streamlining workflows to improve patient experience and boost throughput.

Designed with extensive input from healthcare professionals, Definium Pace Select ET brings the advanced image quality typically found in more expensive overhead tube suspension (OTS) systems to a more affordable, floor-mounted platform. Key innovations include advanced automation to minimize workflow steps and reduce physically demanding tasks, potentially lowering the risk of work-related injuries, along with AI-powered Helix™ Advanced Image Processing to reduce image variability. Additionally, the Intelligent Workflow Suite helps prevent errors before they occur by automating patient positioning, protocol selection, body habitus detection, collimation, and performing a quality check prior to radiation exposure.

According to DelveInsight’s “Digital Radiography Systems  Market Report”, the global digital radiography or X-ray systems market is expected to grow at a CAGR of 5.53% during the forecast period from 2024 to 2030. The digital radiography systems market is witnessing positive growth owing to various factors such as rising cases of cancer, chronic disorders such as cardiovascular disorders, orthopedic, & other disorders, and the escalating burden of geriatric population. Additionally, technological advancements pertaining to the digital radiography systems such as high-quality image acquisition in short duration by digital detectors and reduced radiation exposure, among others will also aid in the growth of the digital radiography systems market. Therefore, the market for digital radiography systems is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.

Inari Medical, Now Part of Stryker, Unveils InThrill® Thrombectomy System to Tackle AV‑Access and Small Vessel Thrombus Cases 

On July 29, 2025, Inari Medical, now part of Stryker, a global leader in medical technologies, announced the launch of the InThrill™ Thrombectomy System, its next-generation solution and the first and only thrombectomy system specifically engineered for small vessels and arteriovenous (AV) access. Designed to meet the unique challenges of these delicate and complex anatomies, InThrill enables rapid, effective, and full luminal clot removal, setting a new standard in targeted thrombectomy care. This purpose-built system reflects a major advancement in precision vascular treatment, offering physicians a powerful tool to improve outcomes in patients with small vessel and AV access-related thrombosis.

“The launch of the next-generation InThrill Thrombectomy System reflects our deep commitment to solving real-world challenges in vascular care,” said Tim Lanier, president, Inari Division. “This latest innovation delivers new tools and enriches our work with physicians in the vascular space.”

The second-generation InThrill™ Thrombectomy System is an advanced French over-the-wire device that includes the InThrill thrombectomy catheter and the InThrill sheath, purpose-built to set a new standard for thrombectomy in AV access and small vessel procedures. Built on a familiar platform and optimized for both performance and usability, InThrill delivers exceptional efficiency and effective clot removal. Key design enhancements include increased radial force for improved apposition to the vessel wall, ensuring more complete clot engagement; an offset single open mouth to enhance clot capture and extraction; internal struts that evenly distribute clot material within the device; and a redesigned backend that improves ergonomics and streamlines the user experience. These innovations position InThrill as a powerful and intuitive tool for physicians treating complex vascular thrombosis in delicate anatomy.

According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market Report”, the global Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market was valued at USD 722.78 million in 2023, growing at a CAGR of 6.15% during the forecast period from 2024 to 2030 to reach USD 1033.33 million by 2030. The rise in demand for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices is predominantly attributed to the rising prevalence of neurovascular disorders across the globe, which require Neurovascular Thrombectomy Devices/Neurothrombectomy Devices for their treatment, such as ischemic stroke and hemorrhagic stroke, growing burden of the old age population. In addition, shifting key players focus towards development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors, among others, that are likely to upsurge the market for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices.

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