Olympus Secured FDA Clearance for Cutting-Edge EDOF™ Imaging Endoscopes, Redefining Visibility with Sharper, Blur-Free Views
On May 27, 2025, Olympus Corporation, a global leader in medical technology and endoscopic imaging, announced that it received FDA 510(k) clearance for its next-generation EZ1500 series endoscopes. The newly approved models, including the GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope, are equipped with proprietary Extended Depth of Field (EDOF™) technology and represent a significant advancement in the company’s EVIS X1™ endoscopy platform.
The integration of EDOF™ technology allows physicians to obtain high-resolution, sharply focused images across an extended depth range. This innovation enhances visualization of the gastrointestinal (GI) mucosa, supporting improved lesion detection and diagnostic confidence during endoscopic procedures. By maintaining the entire lesion in clear focus, EDOF™ has the potential to contribute to earlier and more accurate diagnoses.
“As a leading global MedTech company, Olympus remains committed to providing advanced options to help physicians offer their patients the best care possible,” said Kurt Heine, Senior Vice President and General Manager for Gastrointestinal Solutions at Olympus Corporation. “Our goal is to elevate the standard of endoscopy, and Extended Depth of Field (EDOF) technology represents Olympus’ most advanced scope technology to help physicians drive the best clinical outcomes for advancing gastrointestinal procedures.”
Olympus Corporation received FDA 510(k) clearance for its EZ1500 series endoscopes, marking a significant advancement in endoscopic imaging and procedural efficiency. The GIF-EZ1500 gastroscope and CF-EZ1500DL/I colonoscope are the first Olympus endoscopes to feature Extended Depth of Field (EDOF™) technology as part of the EVIS X1™ endoscopy platform. EDOF™ technology leverages a dual-prism optical system to split incoming light into two separate beams, one near-focused and one far-focused. These beams are projected simultaneously onto a single image sensor and then merged into a unified, sharply focused image. This approach enables physicians to maintain crisp, detailed views across a broad range of depths, minimizing image blurring and enhancing mucosal inspection.
The EZ1500 series also introduced the new ErgoGripTM control section, designed with user ergonomics in mind. The control section was approximately 10% lighter than the previous 190 series and features a rounded, easy-to-maneuver handle with accessible angulation knobs optimized for a broad range of users, including those with smaller hands. When connected to the EVIS X1 CV-1500 video system center, the EZ1500 series scopes were compatible with Olympus’ suite of advanced imaging technologies, including Texture and Color Enhancement Imaging (TXI™), Red Dichromatic Imaging (RDI™), and Narrow Band Imaging™ (NBI™), which further enhances visualization and clinical decision-making.
As per DelveInsight’s “Endoscopes Market Report”, the global endoscopes market was valued at USD 12.95 billion in 2023, growing at a CAGR of 6.05% during the forecast period from 2024 to 2030 to reach USD 18.32 billion by 2030. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic diseases that require the use of endoscopes for the diagnosis, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and Crohn’s disease, increase in the number of geriatric population who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2024 to 2030.
Abbott Gained FDA Approval for Groundbreaking Tendyne™ Device, Pioneering Minimally Invasive Mitral Valve Replacement
On May 27, 2025, Abbott announced the U.S. Food and Drug Administration (FDA) approval of its Tendyne™ Transcatheter Mitral Valve Replacement (TMVR) system, a breakthrough minimally invasive therapy for patients with mitral valve disease who are not candidates for conventional surgery. This approval marks a major advancement in structural heart care, providing a critical new option for treating patients with severe mitral annular calcification (MAC), a complex condition characterized by calcium buildup in the mitral valve annulus that impairs valve function.
The Tendyne system is designed to replace a dysfunctional mitral valve through a transcatheter approach, eliminating the need for open-heart surgery. This innovation provides a life-saving alternative for high-risk patients with severe MAC, a population with limited treatment options and historically poor outcomes. With this approval, Tendyne becomes the first and only TMVR device specifically indicated in the U.S. for the treatment of patients with mitral valve dysfunction due to MAC, further strengthening Abbott’s leadership in the fast-growing market for minimally invasive structural heart therapies. The system complements Abbott’s comprehensive portfolio, which includes technologies for mitral and tricuspid valve repair and replacement.
“Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart’s ability to pump blood effectively. These conditions can have a significant impact on a patient’s quality of life, causing symptoms such as chest pains, shortness of breath and dizziness,” said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. “Unfortunately, patients with MAC can be very difficult to operate on and many are considered too high risk for open-heart surgery due to multiple co-morbidities or other factors. Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.”
“Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio that offers less invasive treatment options for a range of heart diseases,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “This approval builds on our more than two decades of mitral valve leadership that includes developing first-of-their-kind devices that truly change – and save – people’s lives.”
The Abbott Tendyne™ TMVR system features a unique, self-expanding valve design available in multiple sizes, enabling it to accommodate a wide range of patient anatomies. Delivered through a small chest incision, the valve is advanced into the heart and can be fully repositioned or retrieved during the procedure, helping ensure optimal placement and patient outcomes. This FDA approval highlights Abbott’s continued commitment to advancing minimally invasive, catheter-based heart therapies that improve outcomes, reduce surgical risk, and expand access for patients with limited treatment options.
As per DelveInsight’s “Transcatheter Mitral Valve Repair Devices Market Report”, the global transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.
Exact Sciences Validated Oncodetect™ Test in New Study, Advancing MRD Detection and Recurrence Prediction in Stage II-IV Colorectal Cancer
On May 28, 2025, Exact Sciences Corp., a leader in cancer diagnostics, announced new clinical validation data for its tumor-informed molecular residual disease (MRD) test, Oncodetect™, to be presented at the 2025 ASCO Annual Meeting. Findings from the Beta-CORRECT study, part of the GALAXY cohort, confirm the test’s ability to predict cancer recurrence in stage II-IV colorectal cancer, reinforcing its value in guiding treatment and surveillance decisions. Looking ahead, Exact Sciences will launch a next-generation version of Oncodetect™ in 2026, powered by the Broad Institute’s MAESTRO technology. This advanced test will track up to 5,000 patient-specific variants and detect circulating tumor DNA (ctDNA) at levels below 1 part per million, offering even greater sensitivity. The updated test will be available to both new and existing customers.
At the 2025 ASCO Annual Meeting, Exact Sciences shared new results from its largest molecular residual disease (MRD) clinical study to date, Beta-CORRECT. The data confirmed that the Oncodetect™ test accurately predicted recurrence in stage III colorectal cancer, consistent with previous findings from the Alpha-CORRECT study, and further extended this association to stages II and IV. In a cohort of over 400 patients, those who tested ctDNA-positive after treatment or during surveillance had a 24- and 37-fold increased risk of recurrence, respectively. By tracking ctDNA levels over time, Oncodetect supports more informed treatment and surveillance decisions, helping physicians personalize care throughout the patient journey.
“We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that’s already being realized,” said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. “We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility.”
“The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology,” said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. “This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes.”
Exact Sciences is developing a next-generation molecular residual disease (MRD) test designed to monitor up to 5,000 patient-specific variants with a limit of detection below 1 part per million. Currently, in validation across multiple solid tumor types, this highly sensitive test will support broad clinical applications and scalable cancer monitoring. The test is powered by MAESTRO, a proprietary whole-genome sequencing technology exclusively licensed from the Broad Institute. MAESTRO enables accurate detection of low-frequency ctDNA mutations across thousands of sites while reducing sequencing depth, delivering high performance at a lower cost.
As per DelveInsight’s “In-Vitro Diagnostics Market Report”, the global in-vitro diagnostics market was valued at USD 71.01 billion in 2024, growing at a CAGR of 4.71% during the forecast period from 2025 to 2032, to reach USD 93.60 billion by 2032. The in vitro diagnostics market is estimated to register positive revenue growth owing to factors such as the rising prevalence of various infectious diseases, such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics, among others.
Sensome Completed Enrollment in First-in-Human Study of In Situ Tumor Detection System for Lung Cancer, Marking Key Milestone in Early Diagnosis Innovation
On May 27, 2025, Sensome, a leader in microsensing technology for real-time, intraoperative tissue analysis, announced the completion of patient enrollment in its groundbreaking INSPECT clinical study. This first-in-human, multi-center, single-arm trial is evaluating Sensome’s novel tumor detection system, developed to identify cancerous tissue in situ during transbronchial biopsies of endobronchial and peripheral lung tumors.
The INSPECT study enrolled 27 patients, aimed to assess the ability of the technology to accurately identify lung lesion tissue and differentiate cancerous from healthy tissue in real time. Sensome’s proprietary microsensing platform is designed to provide immediate feedback to bronchoscopists, confirming needle placement within a tumor without relying on imaging modalities that often lack the resolution to clearly detect malignant tissue.
“We are very encouraged by our experience using the Sensome tumor detection technology. It has significant potential to make lung biopsies more efficient, and our treatment of lung cancer – the leading cause of cancer deaths globally – more effective,” said Amir Hanna, MD, Interventional Pulmonologist, Coordinating Investigator of the INSPECT study, and Principal Investigator at Lannelongue Hospital, France.
“We found the technology easy to understand and integrate into our bronchoscopy workflow, as the microsensor is integrated into a wire delivered through the biopsy needle, similar to the current stylet we typically use,” added David Fielding, MD, Associate Professor, Director of Thoracic Medicine, and Principal Investigator of the study at Royal Brisbane and Women’s Hospital in Australia.
Sensome’s proprietary sensor technology leverages electrical impedance spectroscopy to analyze tissue characteristics in a full 360° view around the sensor tip. This miniaturized sensing platform is compact enough to be integrated into a medical device introduced through a standard biopsy needle, enabling real-time, in situ tissue assessment. By guiding physicians to the optimal biopsy site with greater precision, Sensome’s tool-in-lesion system may help accelerate lung cancer diagnosis and reduce the need for repeat procedures. The ability to identify tumor tissue on the spot has the potential to significantly improve procedural accuracy and streamline the care pathway for patients with suspected lung cancer.
As per DelveInsight’s “Cancer Diagnostics Market Report,” the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer Diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus on developing advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.
On May 21, 2025, Johnson & Johnson MedTech, a global leader in the treatment of cardiac arrhythmias, announced the U.S. launch of the SOUNDSTAR CRYSTALTM Ultrasound Catheter, a next-generation device designed to enhance intracardiac echocardiography (ICE) imaging during cardiac ablation procedures. SOUNDSTAR CRYSTALTM delivers improved 2D image quality compared to existing ICE catheters, providing electrophysiologists with clearer visualization to support precision in complex procedures. Fully integrated with the CARTO™ 3 Mapping System, the catheter works seamlessly with the CARTOSOUND™ FAM module, which leverages artificial intelligence to streamline mapping and improve procedural efficiency.
The CARTOSOUND™ FAM module utilizes a novel AI algorithm to automatically generate a 3D anatomical map of the left atrium based on ICE images collected during a rotational sweep of the catheter in the right atrium. This AI-driven approach enhances workflow integration and simplifies left atrial anatomy reconstruction, enabling faster and more informed decision-making for electrophysiologists.
“We are proud to advance our legacy in integrated ultrasound catheters with this latest innovation that equips electrophysiologists with the tools they need to promote patient safety and drive effective results,” said Jasmina Brooks, President, Electrophysiology, Johnson & Johnson MedTech. “The superior image quality, improved catheter maneuverabilityii and stability of the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, along with seamless CARTO™ 3 System integrationi can help enable a zero fluoroscopy workflow, enhancing procedure effectiveness and safety for both healthcare professionals and patients they treat.”
“During the cases I performed with the SOUNDSTAR CRYSTAL™ Ultrasound Catheter, I was impressed by the clear visualization, tissue definition and enhanced far field imaging, and full integration with other platforms. Integration with the CARTO™ 3 System provides clear, high-resolution images which simplify the anatomical mapping process and procedure workflow,” said Amin Al-Ahmad, MDx, St. David’s HealthCare, Austin, TX.
The SOUNDSTAR CRYSTAL™ Ultrasound Catheter is the latest advancement in Johnson & Johnson MedTech’s comprehensive portfolio of ultrasound solutions, designed to support precision and efficiency in cardiac procedures. Featuring an 88-element phased linear array, the catheter delivers exceptional image quality and detailed visualization of complex intracardiac structures, critical for guiding catheter ablation procedures. Seamlessly integrated with the CARTO™ 3 System, SOUNDSTAR CRYSTAL™ supports a cohesive, streamlined workflow. Its optimized design offers an ideal balance of stiffness and flexibility, providing electrophysiologists with enhanced control and maneuverability within the heart.
SOUNDSTAR CRYSTAL™ builds on the momentum of recent innovations such as the NUVISION™ Catheter, which brings advanced 4D imaging capabilities to procedures like Left Atrial Appendage Closure (LAAC). Together, these technologies reflect Johnson & Johnson MedTech’s commitment to advancing intracardiac imaging and empowering physicians with tools that drive accuracy, efficiency, and improved patient outcomes.
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 pertaining to 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.
Terumo Corporation Released ROADSAVER™ Carotid Stent System Commercially, Enhancing Clinical Outcomes in Carotid Artery Stenting to Addresses Carotid Artery Stenosis
On May 27, 2025, Terumo Interventional Systems (TIS), a division of Terumo Corporation, announced the early commercial availability of the FDA-approved ROADSAVER™ Carotid Stent System in the United States. This innovative device is indicated for use with the Nanoparasol® Embolic Protection System and is designed to treat carotid artery stenosis in patients at increased risk of complications from carotid endarterectomy. The ROADSAVER™ Stent System features a unique dual-layer micromesh design, offering the protection of a closed-cell stent with the flexibility and deliverability of an open-cell stent. This hybrid structure is engineered to optimize plaque coverage and reduce the risk of embolic events, while maintaining the conformability needed to navigate complex vascular anatomy.
“ROADSAVER Stent System is yet another example of our unrelenting pursuit of achieving better outcomes for patients,” said Chris Pearson, Executive Vice President – US Commercial Operations, Terumo Interventional Systems. “Its rapid delivery and accurate placement drive procedure predictability and efficiency, differentiating it from other carotid artery stents on the market and providing a level of confidence unmatched in the industry.”
“An inner micromesh layer with a pore size four times smaller than any carotid stent, which provides sustained embolic protection, makes the ROADSAVER Stent System a leading technology in the evolution of CAS,” said Michael J. Martinelli, MD, FACC, FSCAI, and Chief Medical Officer, Terumo Medical Corporation. “This is supported by the results of clinical trials, which demonstrated that using ROADSAVER for symptomatic patients with high-risk lesions is safe and effective, with a low complication rate.”
The ROADSAVER™ Carotid Stent System is the first and only dual-layer micromesh stent approved for carotid artery stenting (CAS) in the U.S. Its innovative design combines the benefits of a closed-cell stent with excellent plaque coverage and the flexibility of an open-cell stent, ensuring optimal wall apposition even in challenging anatomies. It is uniquely engineered to contain plaque against the vessel wall and prevent plaque protrusion, helping to reduce the risk of distal embolization. ROADSAVER™ is available in a wide range of sizes (5–10 mm width; 22–47 mm length) and features a 143 cm rapid-exchange shaft for ease of use. Its low-profile 5Fr design improves crossability, and the stent is fully re-sheathable and repositionable, even after 50% deployment, offering greater control during placement.
According to DelveInsight’s “Carotid Artery Stent Market Report”, the global carotid artery stents market was valued at USD 575.76 million in 2023, growing at a CAGR of 3.21% during the forecast period from 2024 to 2030 to reach USD 718.25 million by 2030. The demand for carotid artery stents is primarily being boosted by the increasing prevalence of cardiovascular disorders such as stroke, ischemic stroke, and Transient Ischemic Attack (TIA), among others. Additionally, the increasing demand for minimally invasive surgical procedures is another key factor influencing the positive growth of the market. Further, rising technological developments in the domain of stents is also contributing to the overall growth of the carotid artery stents market during the forecast period from 2024 to 2030.
