Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification
On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent safety, performance, and quality requirements set under the EU MDR framework and assessed by EU-approved notified bodies. This certification, which is mandatory for commercialization in the European Union and other regions recognizing CE Mark standards, enabled broader market access for the system. The Imagio® System was designed to help physicians and healthcare facilities differentiate between benign and malignant breast lesions by using a novel combination of artificial intelligence (SenoGram®), ultrasound, and opto-acoustic imaging technology, supporting clinical decisions on whether invasive diagnostic procedures were necessary. Seno Medical had previously received its first CE Mark under the Medical Device Directive (MDD) in 2014, and the Model 9100 represented a market-optimized update, incorporating state-of-the-art opto-acoustic imaging capabilities and native AI-driven clinical decision support.
The Imagio® technology combined light, sound, and artificial intelligence to generate diagnostic information previously unavailable from conventional imaging modalities. Opto-acoustic imaging served as a novel medical imaging approach by integrating functional, anatomic, and morphologic data via laser-based optics and sound waves, and proprietary AI algorithms to produce high-resolution, high-contrast images with decision-support insights for clinicians. The system delivered a non-invasive diagnostic solution that did not rely on ionizing radiation, contrast agents, breast compression, or limitations on patient body habitus, as seen with MRI. It provided real-time imaging and same-day results, improving workflow efficiency in diagnostic centers while reducing patient stress and anxiety. The system was indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients referred for diagnostic breast imaging following clinical findings or prior examinations such as screening mammography.
“EU MDR certification is one of the most challenging regulatory processes, and we are so pleased to have achieved this significant milestone for our most recent version of the Imagio® System,” commented Tom Umbel, CEO of Seno Medical. “Imagio® delivers a revolutionary leap forward in patient care, and we are thrilled to be able to collaborate with our European colleagues to improve diagnostic processes for providers and patients.”
As per DelveInsight’s “Diagnostic Imaging Equipment Market Report,” the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2020 and is projected to grow at a CAGR of 5.10% from 2024 to 2030, reaching USD 33.56 billion. The demand for Diagnostic Imaging Equipment is primarily driven by rising technological advancements, the growing burden of chronic diseases, increasing patient awareness of early-stage diagnosis, the need for effective & efficient imaging technologies for diagnosis, and an aging population.
Spine Innovation Announced the FDA 510(k) Clearance for LOGIC™ Titanium Expandable Interbody System
On January 26, 2026, Spine Innovation, LLC, a medical device startup focused on developing novel interbody fusion implants, announced that it had received FDA 510(k) clearance to market the LOGIC™ Titanium Implant System. The LOGIC™ Implant System represented the next-generation version of the LOGIC™ platform and incorporated OsteoSync™ Ti, a patented pure titanium lattice material developed by Sites Medical that had been implanted in more than 250,000 patients since 2014.
The patented LOGIC™ implant was designed with a reduced profile during implantation and expanded to more than double its size once deployed, providing enhanced stability and increased bone graft volume. This expandable design had been used successfully in the U.S. for approximately 10 years and had previously been manufactured from polyether ether ketone (PEEK). The implant restored disc height and sagittal balance while resisting subsidence and expulsion, supported by an expanded footprint of 18 mm × 26 mm that spanned the vertebral body. With the FDA clearance, the LOGIC™ implant became available in the OsteoSync™ Ti material, offering advanced structural support and improved bone integration.
As per DelveInsight’s “Spinal Fusion Devices Market Report,” the spinal fusion devices market was valued at USD 7,139.71 million in 2024, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032 to reach USD 10,762.88 million by 2032. The spinal fusion devices market is experiencing steady growth, driven by the rising instances of spinal disorders along with the growing global prevalence of chronic pain. Additionally, conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis are becoming increasingly common, particularly among the aging population. The surge in road traffic accidents further highlights the urgent need for effective spinal fusion solutions to restore mobility and reduce long-term disability. Additionally, the increase in product development activities among key market players is further driving the overall market for spinal fusion devices. Collectively, these factors are anticipated to fuel the expansion of the spinal fusion devices market over the forecast period from 2025 to 2032.
Laborie Acquired the JADA® System for Rapid Postpartum Hemorrhage Control, Expanding Obstetrics Portfolio
On January 28, 2026, Laborie Medical Technologies Corp (“Laborie”) announced that it had completed the previously announced acquisition of the JADA® System, marking a significant milestone in the expansion of its obstetrics portfolio. The addition of the JADA System, an FDA-cleared device designed for the rapid control and treatment of abnormal postpartum uterine bleeding, further strengthened Laborie’s commitment to improving the patient journey through innovative solutions that enhance maternal health and safety.
The JADA System became part of Laborie’s comprehensive obstetrics portfolio, which spanned antepartum, intrapartum, postpartum, neonatal, and surgical care. By addressing postpartum hemorrhage (PPH)—one of the most critical complications of childbirth and the leading cause of maternal mortality globally—the device played a key role in tackling an urgent clinical need. Each year, millions of women experience PPH, accounting for more than 20% of all maternal deaths worldwide, underscoring the importance of effective and timely intervention solutions such as the JADA System.
As per DelveInsight’s “Maternal Mental Health Market Report,” the global maternal mental health market is estimated to grow at a CAGR of 14.57% during the forecast period from 2024 to 2030. The demand for maternal mental health is primarily being boosted by the growing prevalence of maternal mental health disorders such as postpartum depression, dysthymia, pregnancy-related anxiety, birth-related PTSD (Post-traumatic stress disorder), and others. Furthermore, the growing awareness regarding maternal mental health issues and increasing regulatory approvals for various therapies associated with maternal mental health are also driving the market. Additionally, the growing number of innovations in technology, such as the integration of telehealth, mobile apps, and digital health platforms with maternal mental health solutions, are some of the other key factors that are responsible for contributing to the positive growth of the maternal mental health market during the forecast period from 2024 to 2030.
Olympus Announced U.S. Launch of the SecureFlex™ Single-Use Fine Needle Biopsy Device
On January 28, 2026, Olympus Corp. of the Americas announced the U.S. launch of its advanced single-use SecureFlex™ fine needle biopsy (FNB) device, designed for endoscopic ultrasound-guided tissue sampling in the diagnosis of conditions such as pancreatic cancer. The SecureFlex™ FNB needle was developed to collect large, intact tissue samples and to improve access to hard-to-reach lesions, including those in the pancreatic head and uncinate process, and was offered in 19G, 22G, and 25G sizes.
The device featured a Dual-Beveled Raptor™ Tip to support precise tissue acquisition while preserving cellular architecture, along with nitinol construction, a multi-layer sheath for smooth handling, and enhanced ultrasound visibility. Olympus also planned to showcase the SecureFlex FNB needle at major endoscopy meetings, including the Cedars-Sinai Endoscopy Symposium and Orlando Live Endoscopy 2026. The launch supported growing clinical demand for high-quality tissue sampling driven by advances in targeted and immunotherapies for pancreatic cancer and complemented Olympus’ broader GI portfolio, including the EU-ME3 Ultrasound Processor for hepatobiliary and pancreatic procedures.
“Gastroenterologists require precision and reliability when performing a biopsy for diagnostic accuracy. Olympus is excited to offer U.S. customers a dependable biopsy solution designed for precision sampling,” said Christian Hagie, Vice President, GI EndoTherapy Business Unit Leader, Olympus Corporation of the Americas. “The SecureFlex EUS-FNB needle offers an advanced design to help physicians perform efficient procedures by facilitating access to complex anatomical structures and obtain adequate samples for diagnostic testing, even in challenging cases.”
According to DelveInsight’s “Biopsy Devices Market Report”, the global biopsy devices market size is expected to increase from USD 5,813.16 million in 2024 to USD 10,812.77 million by 2032, growing at a CAGR of 8.09% during the forecast period from 2025 to 2032. The market of biopsy devices is being primarily driven by the rising incidence of cancer, such as breast, lung, prostate, and colorectal cancer, among others, increasing demand for minimally invasive procedures, increasing technological advancements in devices, and an increase in product development activities among the key market players.
Kardium Announced Publication of PULSAR Pivotal Trial Results in JACC
On January 21, 2026, Kardium Inc., an emerging leader in advanced solutions for atrial fibrillation, announced that the results of the PULSAR clinical trial had been published in the Journal of the American College of Cardiology (JACC). The landmark study evaluated Kardium’s Globe® Pulsed Field System for the treatment of paroxysmal atrial fibrillation (PAF).
The multicenter pivotal trial demonstrated that the Globe® System achieved durable pulmonary vein isolation (PVI) in 95% of treated veins with a single pulsed field application, while maintaining a 0% rate of device-related primary safety events. At 12-month follow-up, 78% of patients remained free from atrial arrhythmias, highlighting the system’s effectiveness in treating drug-refractory PAF.
The study enrolled 183 patients across leading clinical centers in North America and Europe, with procedures showing high efficiency in mapping, ablation, and overall treatment times. Importantly, the trial confirmed the strong safety profile of the technology, reporting a 0% primary device-related safety event rate throughout the study period.
“The Globe Pulsed Field System has the potential to transform how we treat atrial fibrillation by delivering durable pulmonary vein isolation with remarkable efficiency and safety,” said Dr. Vivek Reddy, Principal Investigator of the trial. “These results show that this technology can make a real difference for patients, offering them better outcomes and a safer path to long‑term relief from arrhythmias.”
“The publication of the PULSAR pivotal trial results in JACC is a tremendous validation of the safety, efficacy and efficiency of the Globe System. At Kardium, we are committed to delivering the most advanced system for the treatment of atrial fibrillation,” said Kevin Chaplin, Chief Executive Officer of Kardium.
According to DelveInsight’s “Ablation Devices Market Report,” the global ablation devices market is expected to grow from USD 8,090.31 million in 2024 to USD 15,347.69 million by 2032, at a CAGR of 8.38% during the forecast period from 2025 to 2032. The market for ablation device solutions is primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular diseases, as well as by global technological advancements.
First Patient Treated in Myra Vision’s U.S. ADAPT Clinical Study for Glaucoma
On January 26, 2026, Myra Vision, a Shifamed portfolio company, announced that the first patient had been enrolled in its ADAPT clinical study evaluating the Calibreye™ TGT Surgical System in patients with glaucoma. This milestone marked meaningful progress in the company’s U.S. regulatory pathway, following the FDA’s approval of Myra Vision’s Investigational Device Exemption (IDE) application in August 2025.
The ADAPT trial was designed as a prospective, multicenter, nonrandomized, open-label study and aimed to enroll up to 70 patients with refractory glaucoma, with a 12-month primary effectiveness endpoint. The study assessed the safety and effectiveness of Myra Vision’s titratable glaucoma therapy system, which was developed to optimize intraocular pressure (IOP) reduction in patients undergoing glaucoma surgery. After implantation, the Calibreye™ aqueous shunt was designed to allow slit-lamp–based outflow adjustments, enabling therapy to be tailored over time as individual patient needs evolved.
Glaucoma, the leading cause of irreversible blindness, affected an estimated 80 million people worldwide, and with no cure available, disease management focused on controlling IOP to slow progression. Existing treatment options, including trabeculectomy, tube shunt implants, and newer minimally invasive surgical devices, generally lacked adjustability, highlighting the clinical need addressed by the Calibreye™ system.
“We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System,” said Dr. Godfrey. “The potentially groundbreaking Calibreye System is the first adjustable glaucoma shunt in the United States, aiming to enable clinician-directed postoperative adjustment to support individualized intraocular pressure (IOP) management.”
“We are excited to have enrolled the first patient in our ADAPT clinical study. This is a significant accomplishment for our organization, and an important step towards delivering the Calibreye System to physicians and patients,” commented Robert Chang, President and Chief Executive Officer of Myra Vision. “Subconjunctival filtration procedures like Calibreye are currently being evaluated in a small percentage of eligible moderate to advanced glaucoma patients who require significant pressure reduction. The personalized IOP control provided by Calibreye will offer physicians greater confidence to address the needs of these underserved patients.”
According to DelveInsight’s “Micro Invasive Glaucoma Surgery (MIGS) Devices Market Report”, the Micro Invasive Glaucoma Surgery (MIGS) Device market was valued at USD 406.55 million in 2023, growing at a CAGR of 13.34% during the forecast period from 2024 to 2030 to reach USD 972.26 million by 2030. The demand for microinvasive glaucoma surgery devices is primarily being boosted by the growing prevalence of glaucoma. Furthermore, the increasing lifestyle disorders such as diabetes and hypertension double the chances of causing glaucoma, leading to vision loss and blindness, thereby boosting the market of micro-invasive glaucoma surgery devices. Additionally, advances in product development, such as greater effectiveness and reduced invasiveness, are key drivers of the positive growth of the micro-invasive glaucoma surgery device market during the forecast period from 2024 to 2030.
