“FDA clearance of the WasherCap™ Mini is a tremendous milestone for ABANZA,” said Juan Abascal, Chief Executive Officer at ABANZA. “Our device provides surgeons with a highly reliable solution for suture and tape fixation—particularly in surgeries where precise tension control is critical. For meniscal root repair, its knotless technology corrects extrusion and restores the meniscus to its anatomical position, which we believe will lead to better short and long-term outcomes, while potentially slowing the progression of arthritis.”
The WasherCap™ Mini is the second device in ABANZA’s new platform of products, built on disruptive technology and a shared commitment to advancing soft-tissue repair. This innovative platform will be further expanded with upcoming products, including the WasherCap™ In Line and the LoopCap™, which will offer surgeons robust solutions for a wide range of procedures. These include biceps tenodesis, medial collateral ligament repairs, and challenging foot and ankle pathologies, further enhancing ABANZA’s portfolio and reinforcing its leadership in the field of soft-tissue repair.
As per DelveInsight’s “Knee Reconstruction/Replacement Devices Market Report,” the global knee reconstruction/replacement devices market was valued at USD 7.54 billion in 2023, growing at a CAGR of 4.52% during the forecast period from 2024 to 2030 to reach USD 9.78 billion by 2030. The knee reconstruction/replacement devices market is experiencing significant growth owing to the widespread instances of degenerative bone conditions like osteoarthritis and rheumatoid arthritis, the rise in product development & innovation activities, among others that are acting as key factors, thus contributing to the market growth of the knee reconstruction/replacement devices market during the forecast period from 2024 to 2030.
Cerus Corporation Announced Receipt of CE Mark for Next-Generation INTERCEPT Illumination Device
On March 05, 2025, Cerus Corporation announced the CE mark approval of its next-generation LED-based illumination device, the INT200, for use with the INTERCEPT Blood System for platelets and plasma under the European Union (EU) Medical Device Regulation (MDR). This approval enables Cerus to market the INT200 across the EU and in other regions that recognize the CE mark. While some countries may require additional in-country regulatory approval before commercialization, this marks a significant milestone.
“We are delighted to achieve this important commercial milestone. We believe the INT200 will be the foundational platform for geographic expansion and future growth of the INTERCEPT business,” said Obi Greenman, Cerus’ president and chief executive officer. “Today’s news also demonstrates our continued commitment to customer-centric innovation for the global transfusion medicine community.”
“Taking into account feedback received from our customers, we designed the INT200 to provide a significantly improved user experience and operational benefits through enhanced physical design and a novel software interface while maintaining compatibility with the same disposable processing sets and pathogen inactivation process currently in use,” said Vivek Jayaraman, Cerus’ chief operating officer. “Critically, we believe the INT200 will provide blood centers with the robust and reliable pathogen inactivation platform that they have come to expect from Cerus. We look forward to supporting our existing customers as they transition to this new device over the next few years as well as new customers as INTERCEPT is introduced in additional geographies.”
With the CE mark approvals for the INTERCEPT processing sets for platelets and plasma granted in 2023, this approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma under the EU MDR framework.
As per DelveInsight’s “Blood Purification Devices Market Report”, the global blood purification devices market was valued at USD 4.90 billion in 2023, growing at a CAGR of 4.19% during the forecast period from 2024 to 2030, to reach USD 6.27 billion by 2030. The demand for blood purification devices is primarily witnessing growth on account of the increase in the number of Chronic Kidney diseases (CKD) and End Stage Renal Disease (ESRD) patients, the surge in the cases of hypertension and diabetes leading to kidney disorders, technological advancements in hemodialysis, increasing product approvals, and increase in adoption of blood purification equipment.
Spinal Stabilization Technologies™ Announces Enrollment of First U.S. Patient in IDE Trial for PerQdisc™ Nucleus Replacement Device, Revolutionizing Spinal Care
On March 03, 2025, Spinal Stabilization Technologies, LLC (SST) announced a significant milestone in its mission to transform spinal care: the enrollment of the first U.S. patient in its Investigational Device Exemption (IDE) clinical trial for the PerQdisc Nucleus Replacement Device (NRD). This marks the official launch of SST’s U.S.-based trial, aimed at evaluating the PerQdisc system for patients suffering from degenerative disc disease (DDD).
The IDE trial will evaluate the PerQdisc’s ability to replace the nucleus pulposus of a single lumbar disc (L1-L5) to preserve motion and alleviate pain. Currently, patients suffering from painful lumbar degenerative disc disease (DDD) have limited surgical options, often resulting in spinal fusion, which restricts motion and increases stress on adjacent spinal levels.
“The reduction in pain and overall clinical outcomes observed with PerQdisc during the feasibility trials (over 40 patients treated) have been exceptional,” stated Dr. Pierce Nunley, Principal Investigator and Medical Director of the Spine Institute of Louisiana. “The procedure was notably straightforward, and the recovery period is anticipated to be brief. This technology holds the potential to revolutionize the treatment of patients suffering from discogenic low back pain, providing a straightforward, safe, and minimally invasive option that reduces pain and maintains mobility while restoring functionality.”
“This is an exciting time for SST as we expand our clinical research into the U.S. market,” said Novotny, “With strong clinical results, a highly experienced team, and the addition of Dr. Phillips to our Board, we are well-positioned to bring PerQdisc to patients in need of better treatment options.”
SST’s PerQdisc offers a groundbreaking alternative, providing a solution that avoids fusion and preserves the surrounding anatomy, offering patients a potential improvement in both mobility and quality of life.
According to DelveInsight’s “Spinal Implants Market Report”, the global spinal implants market was valued at USD 13.01 billion in 2023, growing at a CAGR of 5.40% during the forecast period from 2024 to 2030 to reach USD 17.84 billion by 2030. The rise in demand for Spinal Implants is predominantly attributed due to the increasing prevalence of various spinal disorders, which include spinal stenosis, disc herniation, and degenerative disc diseases, among others in the older population across the globe. Moreover, shifting focus towards technological advancement in bone graft products, rising awareness among the patient population regarding spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implants market.
Inspira Technologies Announced Positive Results from Clinical Study of HYLA Blood Sensor, Integrating AI-powered Continuous Blood Monitoring Technology
On March 04, 2025, Inspira™ Technologies OXY B.H.N. Ltd., a pioneer in innovative life-support and diagnostic technologies, announced positive results from the clinical study of its AI-powered HYLA™ blood sensor. Inspira believes these breakthrough results significantly advance the company’s efforts in developing real-time blood monitoring capabilities, enabling early diagnosis and personalized care without the need for intermittent blood draws. This innovation marks a critical step toward transforming patient care by providing continuous, non-invasive monitoring.
The Company is proud to report that the HYLA™ successfully achieved 96% accuracy in its clinical study results for a key parameter, compared to traditional blood test analyzers. Additionally, the study tested new parameters, including a novel indicator for identifying oxygen deficiencies, demonstrating an impressive 92.3% accuracy. The data collected from these clinical studies is being analyzed to further enhance the algorithms and AI-powered learning capabilities of the system.
This real-time, continuous measurement capability the potential to help prevent blood oxygen deficiency during surgical procedures, eliminating the need for traditional blood draws. The clinical study involved six patients undergoing open-heart surgery, with the clip-on HYLA blood sensor attached at two different points on the blood circuit tubing. This setup allowed the sensor to monitor the patients’ blood as it flowed through the system during the bypass procedure—both from the patient to the heart-lung machine and back. The accuracy of the HYLA device was validated by comparing its readings to those obtained from routine blood samples, which were analyzed by traditional blood analyzers.
“We consider these exceptional results that mark a pivotal milestone in our mission to transform critical care monitoring,” said Dagi Ben-Noon, CEO of Inspira Technologies. “We believe that achieving 96% accuracy as reflected in our clinical results in real-time blood monitoring without the need for blood draws represents a significant technological breakthrough. We plan to introduce the HYLA blood monitoring device for wide adoption across various medical procedures, targeting healthcare providers with early detection diagnostics to support patient treatment.”
The clinical study was conducted at Sheba Hospital, ranked among the world’s top 8 hospitals by Newsweek, by the hospital’s medical team and authorized members of the Company. Focused on accuracy testing against current hospital blood lab testing methods, this study marks an important step in validating the HYLA™ blood sensor. The Company plans to advance the study by collecting additional patient data to further enhance the system’s AI-powered learning capabilities. This will contribute to the development of early detection diagnostics software, expanding the potential for real-time, non-invasive monitoring in clinical settings.
According to DelveInsight’s “Blood Gas and Electrolyte Analyzer Market Report”, the global blood gas and electrolyte analyzers market was valued at USD 2,517.65 million in 2024, growing at a CAGR of 5.65% during the forecast period from 2025 to 2032 to reach USD 3,891.67 million by 2032. The demand for blood gas and electrolyte analyzers is primarily driven by the increasing prevalence of chronic diseases, including cardiovascular, respiratory, and kidney diseases, along with conditions such as diabetes. These conditions are particularly common among the growing geriatric population, which is more prone to develop such ailments. Additionally, the rising adoption of Point-of-Care Testing (POCT) enables faster, on-site diagnosis, thus contributing to market growth. Technological advancements such as smaller, portable, and automated analyzers, along with new product launches by key players, further enhance the market’s expansion. All these factors are expected to drive the growth of the blood gas and electrolyte analyzers market during the forecast period from 2025 to 2032.
iCAD and RamSoft Announced Partnership to Deliver ProFound AI-Powered Mammography Solutions Across North America
On March 05, 2025, iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, and RamSoft®, a global leader in cloud-based RIS/PACS radiology solutions for imaging centers and providers, announced a new strategic commercial preferred distributor and integration partnership across the US and Canada. With over 750 sites and thousands of healthcare providers worldwide already utilizing RamSoft’s solutions, this collaboration will bring iCAD’s ProFound AI® Breast Health Suite directly into imaging centers. The integration aims to enhance workflow efficiency, increase diagnostic confidence, and improve patient care, all within the platforms that providers are already using.
“iCAD’s partnership with RamSoft marks an important step in expanding access to AI-powered breast health solutions across North America,” said Dana Brown, President and CEO of iCAD, Inc. “By integrating the ProFound Breast Health Suite into RamSoft’s leading RIS/PACS platform, we are equipping radiologists with the tools they need to enhance early detection and improve patient outcomes.”
“RamSoft is committed to delivering innovative solutions that streamline radiology workflows and improve diagnostic accuracy,” said Vijay Ramanathan, CEO and Co-Founder of RamSoft. “Our collaboration with iCAD allows us to provide an advanced AI-powered mammography solution that enhances efficiency and enables better patient care. The first organization that will jointly be incorporating ProFound AI Breast Health Suite via the RamSoft PowerServer platform is Mammolink.”
The ProFound AI® Breast Health Suite is designed to address key challenges in mammography by offering a comprehensive AI-powered solution. ProFound AI analyzes each mammogram with high sensitivity, identifying suspicious areas earlier and providing radiologists with crucial insights to enhance accuracy and efficiency in screenings. By seamlessly integrating into RamSoft’s imaging platform, ProFound AI empowers radiologists with real-time, data-driven decision support, ultimately improving patient outcomes and operational workflows.
iCAD’s ProFound AI Breast Health Suite will be integrated into the PowerServer cloud-based RIS/PACS platform, which is designed to offer unmatched functionality, flexibility, and data management—making it well-suited for even the most demanding imaging environments. This integration aims to streamline processes and enhance clinical capabilities, allowing for more effective and efficient breast health screenings.
According to DelveInsight’s “Breast Cancer Diagnostics Market Report”, the global breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The Breast cancer diagnostics market is witnessing a positive growth owing to the factors such as, increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2024-2030.
Pulnovo Medical Announced Closing of Nearly USD 100 Million in Series C Financing
On March 04, 2025, Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension and heart failure, announced the successful closing of a Series C financing round, raising nearly $100 million. The round was co-led by Qiming Venture Partners and existing shareholder Lilly Asia Ventures, with participation from OrbiMed and Gaorong Capital on a super pro-rata basis. The proceeds from this round will be used to advance Pulnovo Medical’s global clinical trials, as well as to expand its international operations and strategic initiatives. The round was oversubscribed twice, making it one of the largest fundraisings in recent years within the innovative medical device sector in the Asia-Pacific region. This strong investor confidence highlights the belief in Pulnovo Medical’s global strategy and technical capabilities, further positioning the company for continued growth and success in the global market.
William Hu, Senior Partner of Qiming Venture Partners, said: “Pulnovo Medical’s progress in the field of interventional treatments for heart disease and heart failure is impressive. The company’s PADN technology is now commercially available in mainland China, Hong Kong, and Macau, and in 2024, global multi-center trials will be launched in Portugal, Serbia, Georgia, and Southeast Asia. Following the FDA’s Breakthrough Device Designation, global clinical trials confirm the technology’s leadership and clinical value. As a long-term healthcare investor, Qiming is committed to supporting innovators with a global vision. We are confident in Pulnovo Medical’s potential and will support its international expansion and commercialization, bringing new hope to patients around the world.”
Pulnovo Medical’s flagship product, PADN (Pulmonary Artery Denervation) technology, offers an innovative and effective minimally invasive treatment for pulmonary hypertension, a condition that can lead to heart failure and mortality with limited treatment options. PADN uses radiofrequency ablation to target the pulmonary vascular endothelial sympathetic nerve, effectively reducing pulmonary artery pressure and slowing disease progression. The technology has already received marketing authorization and is making significant strides in the treatment of pulmonary hypertension.
PADN received FDA Breakthrough Device Designation in 2021 for Group I, Group II, and Group IV Pulmonary Hypertension. It was also included in the 2022 European Society of Cardiology and European Respiratory Society guidelines. In 2023, Pulnovo Medical received Compassionate Use Exemption Device Designation for Group I heart disease. The catheter and RF generator received marketing authorization in China in late 2023, marking PADN as a commercially available device in this critical area of intervention. Most recently, in 2024, Pulnovo Medical’s accessory product, the 9F Sheath, received FDA clearance, further expanding the company’s product offering.
As per 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.
