This milestone positions Navi Medical Technologies at the forefront of addressing critical needs in pediatric care, with the potential to significantly improve patient outcomes by minimizing the reliance on confirmatory chest X-rays, reducing care delays, and lowering the risk of complications for vulnerable newborns and children.
“We recognize the tremendous opportunity to bring our ground-breaking technology to the U.S., and we will continue to engage hospital networks and potential partners that can help ensure that our innovations reach the patients who need them most,” said Alex Newton, CEO of Navi. “With FDA clearance in hand, we’re uniquely positioned to drive significant impact in the largest healthcare market in the world. Our investors have the chance to be part of a mission that’s not only financially rewarding but also deeply meaningful. By working together, we can ensure that every critically ill child has access to safer, faster, and more effective care.”
“This local Victorian company will be taking its home-grown technology to the United States – helping make hospital care safer for critically ill newborn babies on the other side of the world.” Breakthrough Victoria, an investor in Navi, also praised the company’s progress. CEO Rod Bristow commented: “As an investor, we are excited about Navi’s trajectory and its potential to become a leader in the paediatric medical device market. With strong fundamentals, regulatory validation, and a clear pathway to commercialization, Navi represents a compelling investment opportunity with both financial and wider societal impact.”
The Neonav® system offers the broadest “Indication for Use” of any tip location system on the market, extending its application from preterm newborns to adults. This versatile system is capable of accurately placing ultra-small 1Fr catheters for very small newborns and is cleared for both above- and below-heart catheter placements. Additionally, the system includes a pioneering feature for continuous surveillance of catheters post-initial placement, helping to prevent serious healthcare complications related to undiagnosed catheter tip movement. These innovative capabilities directly address critical challenges faced by healthcare professionals in neonatal and pediatric care, enhancing patient safety and improving clinical outcomes.
As per DelveInsight’s “Tip Location Devices Market Report”, the global tip location devices market is growing at a CAGR of 4.77% during the forecast period from 2024 to 2030. The growing demand for tip location devices is driven by the increasing prevalence of cardiovascular diseases such as cardiac arrhythmia, atrial fibrillation, and stroke. Moreover, the shift towards minimally invasive procedures, which offer significant advantages over traditional open-heart surgeries, is contributing to market growth. The rising aging population, coupled with ongoing technological advancements in tip location devices, is further fueling the expansion of the market for these devices during the forecast period from 2024 to 2030.
ClearPoint Neuro Announced EU MDR Certification for SmartFlow Cannula, Strengthening Commitment to European Market
On February 12, 2025, ClearPoint Neuro, Inc., a global leader in device, cell, and gene therapy solutions offering precise navigation to the brain and spine, announced that it received European Medical Device Regulation (EU MDR) approval for its SmartFlow Neuro Cannula. The SmartFlow Cannula successfully met the more stringent EU MDR standards well ahead of the 2027 deadline for Class III devices. Additionally, the updated certification extends the SmartFlow Cannula’s shelf life to 48 months in the European Union, doubling the previous shelf life of 24 months. This milestone further strengthens ClearPoint Neuro’s position in the European market and enhances the product’s availability for critical medical procedures.
“Receiving EU MDR clearance for SmartFlow shows our commitment to the European market and to supporting our partners who are running clinical trials or commercializing their therapies in the region,” stated Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “We are also happy to announce the longer 48-month shelf life, which now matches our shelf life in the United States and Brazil, as this will help our customers with inventory management and improve sustainability by reducing waste. We are proud to have achieved this milestone so far in advance of the required timeframe.”
“This approval is made possible by the significant global clinical trial history of the SmartFlow Cannula,” said Jeremy Stigall, Chief Business Officer of ClearPoint Neuro. “Under EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access. The many years of trial experience with the SmartFlow Cannula contributed greatly to its successful review and approval. This approval will give our over 50 biopharma partners, some of whom are headquartered in the EU, the confidence that we can support clinical trials and eventual commercialization globally.”
In the European Union, the SmartFlow Neuro Cannula received CE marking for the delivery of approved fluids into the brain during intracranial procedures, as well as for the injection of Cytarabine and the removal of cerebrospinal fluid (CSF) from the ventricles, specifically using 14 gauge cannulas. Additionally, SmartFlow is featured in the Summary of Product Characteristics for PTC Therapeutics’ Upstaza, the first marketed gene therapy approved for direct infusion into the brain, highlighting its use for the minimally invasive infusion of gene therapy. This further solidifies the SmartFlow Cannula’s pivotal role in advanced neurosurgical and gene therapy procedures.
As per DelveInsight’s “Clot Management Devices Market Report”, the global clot management devices market was valued at USD 1.76 billion in 2023, growing at a CAGR of 4.50% during the forecast period from 2024 to 2030 to reach USD 2.29 billion by 2030. The demand for clot management devices is primarily being boosted by the increasing geriatric population who form a big part of the at-risk population for developing thrombus, the rising prevalence of lifestyle disorders such as hypertension and obesity which massively increase the chances of developing blood clots, and the innovation in product development leading to the development of second-generation thrombectomy devices ultimately contributing in the overall growth of the clot management devices market during the forecast period.
Volta Medical’s AI-Guided Cardiac Ablation Procedure Demonstrated Improved Efficacy in Treating Persistent Atrial Fibrillation in Clinical Trial
On February 14, 2025, Volta Medical, a leading health technology company specializing in artificial intelligence (AI) solutions for electrophysiologists, announced the publication of the landmark TAILORED-AF clinical trial in Nature Medicine. The trial demonstrated that an AI-guided procedure for persistent atrial fibrillation (AF), in combination with conventional pulmonary vein isolation (PVI) treatment, resulted in superior outcomes compared to PVI alone. Specifically, the study showed a higher percentage of patients achieving freedom from AF, with or without anti-arrhythmic drugs, 12 months after undergoing the AI-guided tailored cardiac ablation procedure combined with PVI. Despite advancements in catheter ablation technology, persistent AF remains one of the most difficult AF subtypes to treat, impacting over 70% of all AF patients globally.
The TAILORED-AF clinical trial is the first large-scale transatlantic randomized controlled trial (RCT) in a persistent atrial fibrillation (AF) population to demonstrate the benefit of extending beyond the conventional pulmonary vein isolation (PVI)-only approach with extra-pulmonary vein procedures. Unlike previous studies, which failed to show superior efficacy with alternative ablation strategies for persistent AF, this landmark trial highlighted the advantages of combining PVI with a tailored approach. The Volta AF-Xplorer™, a digital AI companion designed to assist cardiologists in the real-time identification of specific abnormal electrograms (EGMs), particularly spatiotemporal dispersed EGMs, played a pivotal role in the success of the TAILORED-AF trial, providing enhanced precision during the procedure.
“Previously, there has not been a replicable, effective treatment strategy for patients with persistent atrial fibrillation. Volta’s AI solution finally offers a solution for this large and underserved patient population,” said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. “The TAILORED-AF trial highlights AI’s ability to help physicians treat cardiovascular disease and improve patient outcomes. This is the first large-scale international RCT in interventional cardiology demonstrating superior efficacy through the use of AI.”
“Atrial fibrillation, when left untreated, doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke. However, advancements in AI are transforming this landscape,” said Professor Isabel Deisenhofer, German Heart Center Munich Department of Electrophysiology. “This trial featuring AI-guided assessment of AF represents a true milestone for improvement of outcomes for this underserved and difficult-to-treat patient community.”
In the TAILORED-AF clinical trial, adults with symptomatic persistent or long-standing persistent atrial fibrillation (AF), who were candidates for their first ablation, were enrolled across Europe and the United States. A total of 187 patients underwent a tailored cardiac ablation guided by Volta’s AI in addition to pulmonary vein isolation (PVI) (Tailored cohort), while 183 patients received the conventional PVI-only treatment (Anatomical cohort). All participants were followed for 12 months. The trial involved 51 electrophysiologists across 26 centers in 5 countries. The study successfully met its primary endpoint, showing superior outcomes for patients in the tailored cohort compared to those in the Anatomical cohort.
According to DelveInsight’s “Cardiac Ablation Devices Market Report”, the global cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.
WhiteSwell Unveiled New Clinical Data Supporting eLym System for Acute Decompensated Heart Failure Treatment, Addressing Fluid Overload and Congestion in ADHF Patients
On February 13, 2025, WhiteSwell, a company at the forefront of a new approach to treating acute decompensated heart failure (ADHF), announced positive data from 21 patients treated in its DELTA-HF trial evaluating the WhiteSwell eLym™ System. The data, which were presented at the Technology and Heart Failure Therapeutics (THT) meeting in Boston, were shared by Jan Biegus, M.D., deputy scientific director at the Institute of Heart Diseases at Wroclaw Medical University in Poland.
The decongestion of excess lymphatic fluid via the thoracic duct in acute decompensated heart failure (DELTA-HF) Trial is a non-randomized early feasibility study focused on evaluating the safety and performance of the eLym™ System in treating fluid overload or congestion in patients with acute decompensated heart failure (ADHF).
WhiteSwell previously reported early feasibility data from a study of nine patients treated with the eLym™ System, who were followed for six months. The newly presented data expands the cohort to 21 hospitalized patients who received eLym therapy in combination with diuretic therapy and were followed for 90 days. The device was successfully deployed in all 21 patients. Those who underwent treatment with the eLym System and loop diuretics lost a mean of 10.7 lbs (±7.1) from baseline to hospital discharge, with every patient showing weight loss and a resolution or reduction in peripheral edema and orthopnea. Kidney function remained stable throughout treatment and discharge, as measured by creatinine (mean Δ 0.02 ± 0.26 mg/dL). One patient experienced a serious adverse event related to the procedure, device, or therapy, but it resolved before discharge. At 90 days, 9.5% of patients were rehospitalized for heart failure, with no reported deaths.
“Persistent congestion in acute heart failure patients is associated with a high risk of rehospitalization and death. The lymphatic system is believed to be critical in effectively removing excess fluid from the tissues and organs, yet can be dysfunctional in heart failure patients,” said Dr. Biegus. “The eLym System is designed to support lymphatic function during decongestive therapy. In the first 21 patients treated, all patients lost weight and demonstrated concordant signs of decongestion, while maintaining stable renal function. At 90 days, having just 9.5% of patients rehospitalized for heart failure with no deaths is substantially better than rates we see with standard-of-care diuretics alone, which is quite promising.”
“We are encouraged by the clinical results as more patients are treated with the eLym System. WhiteSwell is entering an important phase as we expand our clinical trial sites and look ahead to a randomized controlled trial in the U.S. and other countries,” said Eamon Brady, WhiteSwell CEO. “By supporting the lymphatic system to drain interstitial tissues and organs in conjunction with diuretic therapy, we hope to break the cycle of repeated heart failure hospitalizations for people with ADHF and improve patient outcomes.”
The eLym™ System is a minimally invasive, catheter-based device designed to assist in the removal of excess fluid from tissues and organs (interstitial fluid) in patients with acute decompensated heart failure (ADHF). By supporting the overwhelmed lymphatic system, the eLym System facilitates fluid drainage. The device is deployed in the left internal jugular and innominate veins, near the point where the thoracic duct, the lymphatic system’s primary channel, connects. It creates a low-pressure zone that aids fluid drainage when used alongside intravenous diuretics, providing an innovative solution to managing fluid overload in ADHF patients.
According to DelveInsight’s “Thoracic Drainage Devices Market Report”, the global thoracic drainage devices market is estimated to grow at a CAGR of 4.31% during the forecast period from 2024 to 2030. The demand for thoracic drainage devices is primarily being boosted by the increasing prevalence of cardiovascular and pulmonary disorders. Additionally, the growing incidence of heart and thoracic surgeries around the globe is another key factor, which is contributing to the growth of the thoracic drainage devices market during the forecast period from 2024 to 2030.
On February 12, 2025, Johnson & Johnson MedTech, a leading innovator in neurovascular care, announced the launch of the CEREGLIDE™ 92 Catheter System, a next-generation .092” catheter featuring the INNERGLIDE™ 9 delivery aid. This advanced catheter is designed to facilitate the insertion and guidance of interventional devices within the neurovascular system. The CEREGLIDE™ 92 catheter allows physicians to achieve large distal access and is specifically engineered to provide flow reduction in the M1i when inserting devices for revascularization in patients with acute ischemic stroke. Additionally, the larger lumen offers enhanced distal support for multiple neurovascular tools, making it suitable for treating aneurysms and other hemorrhagic complications.
The CEREGLIDE™ 92 Catheter System features several advanced design elements, including the co-packaged INNERGLIDE™ 9 Delivery Aid and a .092” inner diameter, providing enhanced performance for interventional procedures. It incorporates BRITE-LINE™ Technology for full catheter visibility under fluoroscopy, ensuring precise guidance throughout the procedure. Additionally, the system uses TruCourse™ Technology to increase distal tip flexibility, enhancing catheter trackability and ease of navigation. The CEREGLIDE™ 92 is designed to track to the M1 and provides large distal placement, offering procedural control and visibility for effective treatment in neurovascular procedures.
“Vessel tortuosity and other anatomical challenges are present in approximately 50 percent of mechanical thrombectomy cases, which can increase procedure time or prevent the ability to treat,” said Dr. Brian Jankowitz, Chief of Neurosurgery and Co-Chair of the Stroke and Neurovascular Program at the Hackensack Meridian Neuroscience Institute at JFK University Medical Center. “As an early user of CEREGLIDE™ 92 and INNERGLIDE™ 9, this super large-bore catheter system helps provide quick and seamless access to the M1 with the benefit of flow control, allowing us to rapidly reperfuse the patient and extend the benefits of next-generation stroke technology to more patients.”
Devices within Johnson & Johnson MedTech’s Neurovascular portfolio are developed with deep insights from expert stroke science, particularly through the Neuro Thromboembolic Initiative (NTI). This initiative ensures that the devices are tested in models that closely replicate real-world clinical scenarios, addressing critical unmet needs in the neurovascular space. As a result, these devices are designed to offer innovative solutions that improve outcomes for patients and healthcare providers dealing with neurovascular conditions.
“Johnson & Johnson MedTech is continuing to innovate to help address the access challenges physicians face during mechanical thrombectomy procedures with the launch of CEREGLIDE™ 92,” said Mark Dickinson, Worldwide President, Neurovascular, Johnson & Johnson MedTech. “The CEREGLIDE™ 92 Catheter System is the latest innovation in our CEREGLIDE and ischemic stroke suite of technologies designed to assist physicians in treating their patients and maximizing procedural outcomes, to ultimately change the trajectory of stroke.”
As part of its ongoing sustainability initiatives, the CEREGLIDE™ 92 Catheter System will feature electronic instructions for use (e-IFUs). This move is expected to reduce Johnson & Johnson MedTech’s environmental footprint by lowering CO2 emissions associated with shipments and minimizing post-consumer recycling and medical waste disposal in healthcare systems. By transitioning to e-IFUs, the company aims to further its commitment to sustainability while enhancing operational efficiency. The CEREGLIDE™ 92 Catheter System is now commercially available in the U.S., marking a significant step forward in both innovation and environmental responsibility.
According to DelveInsight’s “Vascular Access Devices Market Report”, the global vascular access devices market was valued at USD 4.59 billion in 2023, growing at a CAGR of 6.64% during the forecast period from 2024 to 2030, to reach USD 6.75 billion by 2030. The demand for vascular access devices is primarily motivated by the growing prevalence of chronic diseases such as cancer, chronic kidney disease, and heart diseases that require the use of these devices. Technological advancements in vascular access devices and the growing aging population which require frequent medical treatment and hospitalization may drive the growth of the market during the forecast period from 2024 to 2030.
Thermo Fisher Scientific Unveiled New Spatial Imaging System, Empowering Researchers with High-Quality Data for Advancements in Spatial Tissue Proteomics
On February 12, 2025, Thermo Fisher Scientific Inc., a global leader in serving science, launched the Invitrogen™ EVOS™ S1000 spatial imaging system. This cutting-edge system overcomes the limitations of existing fluorescent microscopy technologies by enabling researchers to generate multiplexed, high-quality images for multiple samples within hours. By significantly enhancing efficiency, the EVOS S1000 lowers the barrier to entry for researchers into the field of spatial tissue proteomics, paving the way for more advanced and accessible research in this area.
“Understanding tissue structure and function is crucial for developing new treatments for solid tumors and neurodegenerative diseases,” said Trisha Dowling, vice president and general manager for flow and imaging technologies at Thermo Fisher Scientific. “The EVOS S1000 delivers a detailed snapshot of tissue microenvironments and architecture in their native state, helping researchers accelerate their experiments, achieve more with their tissue samples, and drive advancements in critical research areas.”
“Our lab handles everything from project design and sample preparation to imaging, and we must deliver high-quality results to our customers, while also working to support our research projects,” said Carolina Oses Sepúlveda, researcher and lab manager for spatial proteomics at SciLifeLab Stockholm. “With the new EVOS S1000, we can select and utilize any antibody or reagent – allowing us more flexibility to choose the tools that best fit our research needs – or even work without antibodies, all of which reduces sample processing.”
The EVOS S1000, part of Thermo Fisher Scientific’s innovative line of cell imaging microscopes and systems, utilizes advanced and patented spectral technology to enable researchers to capture images of up to 9 different targets simultaneously. This capability reduces the need for multiple imaging rounds and helps preserve tissue integrity. Additionally, the system’s compatibility with a wide range of reagents and antibodies allows for seamless integration into existing laboratory setups, addressing the growing demand for multiplex imaging and enhancing research efficiency in spatial tissue proteomics.
As per DelveInsight’s “Flow Cytometry Market Report”, the global flow cytometry market was valued at USD 4,942.02 million in 2023, growing at a CAGR of 7.52% during the forecast period from 2024 to 2030 to reach USD 7,587.63 million by 2030. The increase in demand for flow cytometry is primarily attributed to the rising research and development activities in the healthcare industry. Further, rising prevalence of chronic and immunological ailments like HIV & AIDS and cancer due to gene mutations, such as smoking, radiation, viruses, cancer-causing chemicals (carcinogens), obesity, hormones, chronic inflammation, and a lack of exercise. The diagnosis of HIV & AIDS and cancer is done by flow cytometry thereby increasing the demand for the device in the market. Additionally, rising advancements in stem cell research and recombinant DNA technology in the development of cancerous and immunology drugs and increasing advancements in flow cytometry software such as providing high-resolution imaging, fluorescence, and laser technology, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the flow cytometry market during the forecast period from 2024 to 2030.
