Johnson & Johnson Received FDA Approval for TRUFILL n BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma
On December 18, 2025, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) had approved an expanded indication for the TRUFILL n-BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) as an adjunct to surgery in the treatment of symptomatic subacute and chronic subdural hematoma (cSDH).
At the time, cSDH was commonly associated with minor head trauma that resulted in bleeding between the dura and arachnoid membranes, particularly among older adults and patients receiving anticoagulation therapy. Although surgery represented the traditional standard of care, recurrence rates were reported to range from 10% to 20%.
Embolization of the MMA was recognized as a minimally invasive endovascular technique that targeted smaller cerebral vessels believed to contribute to hematoma persistence and regrowth.
The FDA approval was supported by data from the MEMBRANE randomized controlled trial, which assessed the safety and effectiveness of MMA embolization in patients with cSDH. Findings from the study showed that TRUFILL n-BCA demonstrated superior efficacy compared with standard of care for MMA embolization in the treatment of symptomatic cSDH, while also confirming a favorable safety profile.
“This approval reinforces the enduring value of TRUFILL n-BCA and our commitment to delivering innovative technologies that improve outcomes for patients and address complex neurovascular conditions,” said Christian Cuzick, President, Worldwide Neurovascular, Johnson & Johnson MedTech.
As per DelveInsight’s “Neurovascular Devices Market Report,” the Global Neurovascular Devices market is expected to increase from USD 3,616.46 million in 2024 to USD 6,814.26 million by 2032, growing at a CAGR of 8.33% during the forecast period from 2025 to 2032. The demand for Neurovascular devices is gaining importance owing to the rising prevalence of the target patient population, increasing demand for minimally invasive neurosurgical procedures, ongoing development of technologically advanced products, and rising R&D investments, among others, which are contributing to the overall growth of the Neurovascular devices market during the forecast period from 2025 to 2032.
Abbott’s Volt™ Pulsed Field Ablation System Received FDA Approval to Treat Patients with Atrial Fibrillation
On December 22, 2025, Abbott announced that the U.S. Food and Drug Administration (FDA) had approved the company’s Volt™ PFA System for the treatment of patients with atrial fibrillation (AFib). Following the approval, Abbott indicated that it would begin commercial pulsed field ablation (PFA) cases in the United States and continue expanding clinical sites across the European Union, after receiving the Volt CE Mark earlier in the year.
At the time of the announcement, atrial fibrillation affected an estimated 12 million people in the United States aged 65 and older, a figure projected to double over the following two decades. Individuals living with AFib were known to have a fivefold higher risk of stroke, and the condition had contributed to mortality in the United States for more than 20 years. For patients who did not respond adequately to medications or other therapies, minimally invasive cardiac ablation procedures were commonly used to control irregular heart rhythms.
The FDA approval of the Volt PFA System was supported by positive findings from Abbott’s VOLT-AF IDE study, which enrolled 392 patients across 40 clinical centers in the United States, Europe, Canada, and Australia. Study results demonstrated clinically meaningful safety and effectiveness outcomes in two patient populations: those with paroxysmal atrial fibrillation, characterized by intermittent episodes, and those with persistent atrial fibrillation, in which episodes lasted longer than seven days.
“AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient’s quality of life. When I perform a cardiac ablation, I look for a tool with an excellent patient safety profile that can simplify the treatment of AFib,” said DJ Lakkireddy, M.D., executive medical director of the Kansas City Heart Rhythm Institute and one of the first physicians to use Volt in the United States. “Volt is a promising option for patients. Its real-time contact visualization and unique balloon-in-basket design provide superior tissue contact and focused energy delivery, while addressing some of the limitations of the early generation PFA systems.”
As per DelveInsight’s “Cardiac Ablation Devices Market Report,” the global cardiac ablation devices market is expected to increase from USD 3,832.19 million in 2024 to USD 10,317.88 million by 2032, growing at a CAGR of 13.25% from 2025 to 2032. The cardiac ablation devices market is experiencing strong growth, driven by rising disease prevalence, evolving patient preferences, and ongoing technological progress. The increasing incidence of cardiovascular disorders, particularly atrial fibrillation, linked to risk factors such as hypertension, diabetes, obesity, and aging populations, has created a pressing need for advanced rhythm management solutions. Growing preference for minimally invasive procedures is further fueling demand, as catheter-based ablation offers faster recovery, reduced complications, and shorter hospital stays compared to traditional surgical approaches. Simultaneously, rapid technological innovations, including advanced radiofrequency and cryoablation systems, contact-force-sensing catheters, and the emergence of pulsed-field ablation, are enhancing procedural precision, safety, and long-term outcomes. Leading manufacturers are actively focusing on next-generation platforms that integrate imaging, mapping, and AI-driven guidance to improve treatment efficacy and expand clinical adoption. Together, these factors are creating a favorable environment that is expected to sustain the upward trajectory of the cardiac ablation devices market in the years ahead.
Medicus Pharma Ltd. Announced the Engagement with Reliant AI to Develop Artificial Intelligence (AI) Driven Clinical Data Analytics Platform
On December 22, 2025, Medicus Pharma Ltd., a precision-guided biotech and life sciences company focused on advancing the clinical development of novel and potentially disruptive therapeutic assets, announced that it had entered into a non-binding letter of intent (LOI) with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to collaborate on the development of an artificial-intelligence-powered data analytics platform aimed at supporting clinical trial execution through data-driven insights.
Reliant AI Inc., a privately held decision-intelligence company founded by former DeepMind and Google Brain researchers Karl Moritz Hermann and Marc Bellemare, along with life sciences expert Richard Schlegel, combined advanced machine-learning capabilities with deep biomedical expertise to power next-generation life sciences research. Its platform automated data-intensive workflows ranging from systematic literature reviews to commercial success prediction enabling biopharmaceutical teams to make faster, evidence-based decisions.
Under the proposed collaboration, the platform was intended to enhance data-driven decision-making across Medicus’ clinical pipeline by integrating Reliant’s proprietary AI technology with Medicus’ clinical, operational, and proprietary datasets. The platform was expected to support more efficient trial execution, including dynamic clinical-site selection, patient stratification, and enrollment forecasting. The initial phase of the collaboration was planned to focus on dynamic site selection, supported by targeted patient-stratification analyses, for an upcoming Teverelix clinical study expected to commence in 2026.
“This proposed collaboration reflects an important strategic step of selectively deploying advanced analytics and AI tools to improve the efficiency, quality, and predictability of clinical development,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO “by integrating AI-enabled modeling with our clinical and pharmacodynamic data, we aim to support more precise trial execution while maintaining capital discipline We see this as the foundation for a broader, data-driven clinical execution capability. Starting with Teverelix, our goal is to apply these insights to improve trial efficiency, inform patient selection, and support smarter decision-making as our programs move toward late-stage development.”
As per DelveInsight’s “Artificial Intelligence (AI) in Clinical Trials Market Report,” the global artificial intelligence in clinical trials market is expected to increase from USD 1,350.79 million in 2024 to USD 3,334.47 million by 2032, growing at a CAGR of 12.04% during the forecast period from 2025 to 2032. The demand for AI in clinical trials is growing robustly, driven mainly by the increasing global burden of chronic diseases such as diabetes, cardiovascular conditions, respiratory disorders, and cancer. This surge is further supported by rising investment and funding aimed at advancing drug discovery and development. Moreover, the growing trend of strategic collaborations and partnerships among pharmaceutical, biotechnology, and medical device companies is accelerating the adoption of AI-powered clinical trial solutions. Collectively, these factors are expected to propel the expansion of AI in the clinical trials market throughout the forecast period from 2025 to 2032.
Solventum Completed the Acquisition of Acera Surgical
On December 23, 2025, Solventum announced that it had completed the acquisition of Acera Surgical (Acera), a privately held bioscience company focused on the development and commercialization of fully engineered materials for regenerative wound care. Under the terms of the agreement, Solventum acquired Acera for an upfront cash payment of $725 million, subject to customary purchase price adjustments, along with up to $125 million in contingent cash payments tied to the achievement of specified future milestones.
The company stated that the transaction was expected to be slightly dilutive to adjusted earnings per share (EPS) in 2026 and accretive to adjusted EPS beginning in 2027, while having no material impact on fourth-quarter 2025 financial results. Acera was projected to generate approximately $90 million in revenue in 2025.
Further details regarding the transaction were provided in the acquisition announcement press release issued on November 20, 2025. Morgan Stanley & Co. LLC acted as financial advisor to Solventum, with McDermott Will & Schulte LLP serving as its legal advisor. Truist Securities advised Acera on the transaction, while Hogan Lovells US LLP served as Acera’s legal counsel.
“Announcing and completing our first strategic acquisition is a significant milestone and the successful completion of another commitment made as part of our three-phased transformation plan,” said Bryan Hanson, chief executive officer of Solventum. “The addition of Acera’s innovative synthetic tissue matrix technology complements our existing advanced wound care portfolio, enhancing the solutions our specialized commercial team can provide to clinicians and decision makers in acute care settings. We are excited to welcome the Acera team to the Solventum family and look forward to our work together to accelerate growth and create significant value for patients, clinicians and shareholders.”
According to DelveInsight’s “Advanced Wound Care Market Report”, the advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2025 to 2032, to reach USD 16.97 billion by 2032. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence, such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players. This is expected to significantly drive the demand for advanced wound care from 2025 to 2032.
Envoy Medical Reached Enrollment Milestone in Pivotal Clinical Study of Fully Implanted Acclaim(R) Cochlear Implant
On December 18, 2025, Envoy Medical® Inc., a hearing health company focused on the development of fully implanted hearing solutions, announced that its pivotal clinical study for the investigational fully implanted Acclaim® cochlear implant had reached a significant milestone by achieving the midpoint of its total enrollment target.
The company noted that, despite challenges related to holiday scheduling and year-end operating room availability, patient enrollment was progressing steadily, with participating clinical sites actively screening a large number of potential candidates. Envoy Medical stated that full enrollment remained on track and was expected to be completed within the first half of Q1 2026.
“Reaching the midway point of the study’s enrollment is another strong indication that our pivotal study continues to move forward efficiently,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “Even in a season that traditionally makes scheduling difficult, the investigational sites and our internal teams are performing exceptionally well.”
Lucas added, “We believe our fully implanted approach represents the future of hearing implants. The momentum in our pivotal study and the enthusiasm we are seeing from professionals in the field underscore the strong differentiation of our technology and our leadership as the industry shifts toward fully implanted solutions.”
According to DelveInsight’s ”Cochlear Implants Market Report,” the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is experiencing substantial growth, primarily driven by the increasing prevalence of hearing loss & which incurs high economic costs. Investing in cochlear implants & improving access to these devices, along with supportive reimbursement policies, are expected to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
Galaxy Therapeutics Completed Enrollment in Pivotal SEAL IT IDE Trial
On December 23, 2025, Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on the treatment of brain aneurysms, announced that it had completed patient enrollment in SEAL IT, its U.S. Investigational Device Exemption (IDE) trial evaluating the SEAL device for the treatment of brain aneurysms. The multicenter, prospective study involved 50 clinical sites and enrolled 279 patients across three primary aneurysm cohorts: wide-neck bifurcation aneurysms (WNBA), sidewall aneurysms, and ruptured aneurysms.
The WNBA cohort was designed to build on the foundation of the earlier WEB-IT trial while expanding the indication to include a broader range of aneurysm sizes. The Sidewall cohort focused on patients with single-vessel, non-bifurcation aneurysms, whereas the Ruptured cohort included patients treated during the acute phase of subarachnoid hemorrhage. Collectively, these cohorts enabled a comprehensive assessment of the SEAL device across a wide range of aneurysm types and clinical treatment scenarios.
“Completing enrollment in SEAL IT is a major milestone not only for Galaxy but for the field of neurointervention,” said Dr. Sam Zaidat, President and CEO of Galaxy Therapeutics. “We designed this study to reflect real-world aneurysm complexity and believe the evidence generated will meaningfully advance the care of these patients.”
“It is impressive that all three arms of the trial progressed so rapidly. It’s a testament to our enrolling physicians’ ability to integrate a new device into their practices and the ease of use of the device itself”, said Dr. Michael Alexander, Galaxy Therapeutics CMO.
“SEAL IT represents an important step in advancing clinical research for complex aneurysms such as wide-neck bifurcations. The design of the study reflects a broad real-world population, and I’m grateful to all participating centers and colleagues,” said Dr. David Altschul, Principal Investigator and Chief of Neurointerventional Surgery at Montefiore Medical Center.
“SEAL IT is one of the first prospective U.S. IDE trials to include a ruptured aneurysm cohort, a critical and underrepresented population in device studies. To our knowledge, it is also among the fastest-enrolling aneurysm studies in the U.S., a testament to the engagement of investigators across the country,” added Dr. Brian Jankowitz, Principal Investigator and Chief of Neurosurgery at Hackensack Meridian Neuroscience Institute.
According to DelveInsight’s “Endovascular Aneurysm Repair Devices Market Report”, the endovascular aneurysm repair devices market was valued at USD 2,937.61 million in 2024, growing at a CAGR of 5.85% during the forecast period from 2025 to 2032, to reach USD 4,613.26 million by 2032. The rising incidence of abdominal and thoracic aortic aneurysms (AAA and TAA) is significantly driving the Endovascular Aneurysm Repair (EVAR) market. As the aging population grows, demand for effective, minimally invasive treatments like EVAR increases, given its benefits of reduced hospitalization, lower complication rates, and quicker recovery compared to traditional surgery. Additionally, continuous advancements in EVAR device technology, such as more flexible stent grafts and improved imaging for precise placement, are expanding its applicability to a broader range of patients, further boosting market growth. Together, these factors are expected to increase demand for endovascular aneurysm repair devices globally during the forecast period from 2025 to 2032.
