Notizia - Recent Pharma, Healthcare and Biotech Happenings
Apr 24, 2025
Table of Contents
On April 18, 2025, Medtronic plc, a global leader in healthcare technology, received FDA approval for its Simplera Sync™ sensor for integration with the MiniMed™ 780G system. This approval enhances the flexibility of Medtronic’s most advanced insulin delivery system, which now supports both the Guardian™ 4 and the newly approved Simplera Sync™ sensors. The Simplera Sync™ is a disposable, all-in-one continuous glucose monitoring (CGM) sensor that eliminates the need for fingersticks when used with SmartGuard™ technology and requires no overtape. Featuring a streamlined two-step insertion process, the Simplera Sync™ broadens Medtronic’s CGM portfolio and offers users a more convenient and adaptable diabetes management solution.
The MiniMed™ 780G system represents a significant advancement in automated insulin delivery, offering a highly adaptive algorithm that automatically anticipates, adjusts, and corrects† glucose levels every five minutes—24 hours a day, seven days a week. As the only system on the market to feature Meal Detection™ technology, it intelligently responds to rising glucose levels by delivering additional insulin when needed, helping users maintain optimal glucose control—even in instances of missed or underestimated meal boluses. Utilizing a “treat to target” strategy with flexible glucose targets as low as 100 mg/dL, the MiniMed™ 780G system is designed to more closely replicate glucose patterns of individuals without diabetes. Real-world data supports its effectiveness, with users consistently achieving time in range (TIR) above the internationally recommended threshold of 70% when using optimal settings.
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We’re committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed™ 780G system delivers advanced diabetes technology for so many around the world, and we’re excited to continue evolving this experience with expanded CGM options —including our Simplera Sync™ sensor, which we look forward to bringing to people living with diabetes in the US.”
Additionally, it is the only system compatible with the world’s first and only 7-day infusion set, significantly reducing the burden of therapy by enabling users to change their infusion set just once per week—resulting in up to 96% fewer injections compared to traditional multiple daily injection regimens. This combination of advanced automation, flexibility, and convenience underscores the MiniMed™ 780G system’s role as a best-in-class solution for people living with diabetes.
As per DelveInsight’s “Insulin Delivery Device Market Report”, the insulin delivery devices market was valued at USD 15.51 billion in 2023, growing at a CAGR of 9.28% during the forecast period from 2024 to 2030, to reach USD 26.35 billion by 2030. The rise in demand for insulin delivery devices is predominantly driven by the increasing prevalence of diabetes due to lifestyle changes, aging populations, and genetic factors. Secondly, awareness campaigns and educational initiatives have significantly increased public knowledge about diabetes management. Patients and healthcare providers are now more informed about the benefits of using advanced insulin delivery devices, which offer precise dosing, convenience, and improved blood glucose control compared to traditional methods. Additionally, technological advancements have further fueled market growth by introducing innovative features such as smart insulin pumps, continuous glucose monitor (CGM) integration, and mobile app connectivity. Collectively, these factors create a robust market environment that drives the demand for insulin delivery devices, ensuring better health outcomes for diabetes patients during the forecast period from 2024 to 2030.
On April 17, 2025, BVI Medical, a global leader in ophthalmic surgical solutions, announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking glaucoma surgical platform, Leos™ (Laser Endoscopy Ophthalmic System).
Leos™ represents a significant advancement in glaucoma care, introducing a novel and intuitive approach to endoscopic cyclophotocoagulation (ECP). The system is uniquely designed to integrate seamlessly into the surgical workflow, offering a minimally invasive ab interno procedure that effectively reduces intraocular pressure by targeting aqueous humor production—setting it apart as the only laser system of its kind. Equipped with advanced endoscopic technology, Leos™ delivers high-resolution visualization of ocular anatomy beyond what is possible with conventional imaging tools. This enhanced visualization capability supports greater surgical precision and outcomes, positioning Leos™ as a transformative innovation in the treatment of glaucoma.
“This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline that is starting to play out in numerous geographies across the world, including Leos in the US market,” said Shervin Korangy, BVI President and CEO. The momentum for BVI continues to build behind a recent $1bn capital raise and several very high-profile product approvals in the EU and Asian markets.”
This regulatory clearance represents a major milestone in glaucoma treatment, expanding access to advanced care for patients in the earlier stages of the disease and across a broad range of glaucoma types. The innovative, proprietary laser-based system leverages a differentiated mechanism of action and is engineered to provide enhanced, high-resolution visualization of ocular anatomy—positioning it as a cutting-edge solution in the evolving landscape of ophthalmic technologies.
As per DelveInsight’s “Glaucoma Drainage Devices Market Report”, the glaucoma drainage devices market was valued at USD 640.57 million in 2023, growing at a CAGR of 11.95% during the forecast period from 2024 to 2030, to reach USD 1,184.39 million by 2030. The increase in demand for glaucoma drainage devices is primarily due to the rising prevalence of glaucoma across the globe, increasing lifestyle disorders such as diabetes & hypertension, the growing burden of the old age population, and technical innovation in product development are expected to boost the market for glaucoma drainage devices.
On April 22, 2025, Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies, announced the publication of results from the TRANSCEND clinical trial—a global, randomized study evaluating the SurVeil™ drug-coated balloon (DCB) for the treatment of femoropopliteal arterial disease. Published in the March 2025 edition of the European Journal of Vascular and Endovascular Surgery, the study demonstrated that the SurVeil™ DCB is non-inferior to the IN.PACT™ Admiral™ DCB in both safety and efficacy outcomes, while delivering a significantly lower dose of drug. These results support the SurVeil™ DCB as a high-performance, lower-dose alternative in peripheral arterial disease treatment, reinforcing Surmodics’ commitment to advancing vascular innovation with clinically proven, patient-centric solutions.
Surmodics, Inc. announced the publication of the TRANSCEND clinical trial, a landmark global, randomized study demonstrating that the SurVeil™ drug-coated balloon (DCB) is non-inferior to the IN.PACT™ Admiral™ DCB in both safety and efficacy for the treatment of femoropopliteal arterial disease—despite delivering a 75% lower drug dose. Both devices utilize paclitaxel as the anti-proliferative agent; however, the SurVeil DCB features a proprietary, uniform microcrystalline coating with a drug load of 2.0 μg/mm², designed to optimize drug delivery and enhance durability. In contrast, the IN.PACT Admiral DCB a higher drug load of 3.5 μg/mm². The SurVeil DCB, developed and manufactured by Surmodics, is globally marketed by Abbott.
TRANSCEND is the first global, head-to-head trial comparing DCBs in this indication. The prospective, multi-center, single-blind, randomized controlled study enrolled 446 patients (Rutherford categories 2–4) across 65 sites in 9 countries, randomizing them to treatment with either the SurVeil DCB (n = 222) or the IN.PACT Admiral DCB (n = 224). At 12 months, the SurVeil DCB demonstrated comparable outcomes for both the primary efficacy endpoint—primary patency (82.2% vs. 85.9%)—and the primary safety endpoint (91.8% vs. 89.9%), establishing non-inferiority using a robust multiple imputation approach. Secondary outcomes through 24 months also remained consistent across both groups, reinforcing the long-term efficacy of the SurVeil DCB. Five-year follow-up data collection was completed in 2024, underscoring Surmodics’ ongoing commitment to delivering evidence-based innovation in peripheral vascular care.
Surmodics long established itself as a pioneer in drug-delivery technology, with a legacy that began with the development of the coating used on the first-ever drug-eluting stent (DES), the Johnson & Johnson Cypher™ DES. Building on this foundation, the company applied its deep scientific expertise to the creation of the proprietary drug/excipient coating used in the SurVeil™ drug-coated balloon (DCB), setting a new standard in peripheral vascular intervention.
“The publication of TRANSCEND demonstrates its high quality of trial design, conduct, and interpretation of results, and establishes a strong evidence base for physician decision-making,” said co-principal investigator Professor Marianne Brodmann, M.D., Head of the Clinical Division of Angiology at the Medical University of Graz, Austria. “Surmodics demonstrated confidence in its technology by choosing to conduct the first worldwide pivotal trial versus a high-dose device. The study’s global patient enrollment lends added confidence to the generalizability of the results.”
The SurVeil DCB’s development was driven by a clear objective: to enhance drug-delivery performance while minimizing drug load. Through precise control of microcrystalline morphology, Surmodics engineered a uniform microcrystalline paclitaxel coating that was markedly distinct from those found on other DCBs. This innovative coating was specifically designed to optimize drug retention during delivery, ensure sustained drug release and absorption within the vessel wall, and maximize bioavailability—while reducing the potential for downstream embolization by improving coating consistency and durability.
This meticulous development strategy culminated in the TRANSCEND pivotal trial, the first global, head-to-head study comparing a next-generation, low-dose DCB (SurVeil) with the high-dose market leader (IN.PACT™ Admiral™). The study confirmed that the SurVeil DCB achieved non-inferior clinical outcomes in both safety and efficacy, validating Surmodics’ commitment to innovation and reinforcing the company’s position at the forefront of drug-delivery technology in vascular medicine.
According to DelveInsight’s “Drug Eluting Balloons Market Report,” the drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases, including peripheral and coronary artery diseases. Furthermore, the increasing preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and development activities by the key players, among others, are thereby contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2024 to 2030.
On April 21, 2025, Elutia Inc., a leader in drug-eluting biomatrix technologies, announced the launch of the EluPro™ clinical study, aimed at gathering real-world patient outcome data to support the use of its innovative EluPro bioenvelope. As the first and only FDA-cleared antibiotic-eluting bioenvelope indicated for use with both cardiac implantable electronic devices (CIEDs) and neurostimulators, EluPro represents a breakthrough in infection prevention for implantable device procedures.
The study marks a significant step in validating the performance of EluPro in routine clinical practice, with the first patient successfully enrolled at UC San Diego Health. This initiative reflects Elutia’s ongoing commitment to advancing patient care by generating robust clinical evidence around the real-world effectiveness of its pioneering bioenvelope technology.
The EluPro™ clinical study is a multi-center, prospective, post-market investigation designed to evaluate the performance and clinical outcomes of the EluPro bioenvelope in standard clinical practice. This study will assess its effectiveness across a diverse patient population undergoing cardiac implantable electronic device (CIED) implantation.
“Every innovation we pursue is driven by a commitment to improving patient care,” said Kimberly Mulligan, PhD, Vice President and General Manager of Cardiovascular at Elutia. “With EluPro, we combined trusted antibiotics with a soft, regenerative biomatrix to protect the implant, facilitate implantation, and support healing. This study will allow us to collect data on these differentiating characteristics in real-world practice.
The study collected comprehensive data on both clinical outcomes and patient-reported experiences, focusing on key complications following CIED implantation. These include infection, hematoma, lead dislodgement, device migration or erosion, and other implant site-related complications. A total of 100 patients are planned for enrollment, with follow-up conducted over a 12-month period post-implantation. This data will provide valuable insights into the real-world effectiveness of EluPro in preventing complications and improving patient outcomes in the context of CIED procedures.
According to DelveInsight’s “Active Implantable Medical Devices Market Report,” the active implantable medical devices market was valued at USD 25,360.78 million in 2024, growing at a CAGR of 7.82% during the forecast period from 2025 to 2032 to reach USD 46,281.18 million by 2032. The global active implantable medical devices market is propelled by a convergence of factors shaping the medical device landscape. Firstly, the increasing prevalence of chronic diseases, such as neurological disorders, cardiovascular disorders, and hearing disability, fuels the demand for active implantable medical devices. Additionally, in response to this demand, there is a surge in product development activities worldwide, with companies investing in innovative solutions to address these complex health issues. Moreover, enhanced awareness and early diagnosis of chronic diseases further boost the market by encouraging timely intervention and treatment, which in turn drives the need for advanced active implantable devices. This convergence of increasing disease prevalence, innovation in product development, and heightened awareness collectively fosters a robust growth trajectory for the active implantable medical device sector during the forecast period from 2025 to 2032.
On April 21, 2025, BD, a global leader in medical technology, launched the HemoSphere Alta™ platform, an advanced hemodynamic monitoring system that integrates predictive, artificial intelligence (AI)-driven algorithms. This innovative platform is designed to help clinicians proactively manage blood pressure instability and optimize blood flow, potentially preventing life-threatening complications during medical procedures. By leveraging real-time data and AI insights, the HemoSphere Alta™ platform enhances clinical decision-making, improving patient outcomes and supporting safer, more effective care in critical situations.
The HemoSphere Alta™ platform represents BD’s most advanced hemodynamic monitoring technology to date and marks the first major product launch from the company’s Advanced Patient Monitoring business since its acquisition by BD. This cutting-edge platform strengthens BD’s leadership in smart, connected care technologies, leveraging clinical data and AI to support clinicians in improving patient outcomes and optimizing clinical workflows. By providing predictive insights and real-time monitoring, HemoSphere Alta™ enhances clinical decision-making, enabling more proactive management of patient health during critical procedures.
A key innovation in the HemoSphere Alta™ platform is the introduction of the Cerebral Autoregulation Index (CAI), a groundbreaking parameter that helps clinicians determine whether the brain can maintain stable blood flow despite fluctuations in blood pressure. This unique tool provides personalized insights into a patient’s blood pressure requirements, enhancing clinical decision-making. Clinicians can access CAI data when using the noninvasive ForeSight IQ™ Sensor, placed on the patient’s forehead, in combination with the Acumen IQ™ Sensor, connected to the patient’s arterial line.
In addition, the HemoSphere Alta™ platform incorporates Acumen Hypotension Prediction Index (HPI)™ software, which predicts when a patient might experience a low blood pressure event. The HPI™ shown in large multicenter studies to reduce the depth, duration, and severity of hypotension, further supporting the platform’s role in proactively managing patient care and improving outcomes during critical procedures.
“HemoSphere Alta™ marks the latest milestone in our continuum of connected care innovations by redefining the clinician experience with more efficient workflows and increased usability,” said Tim Patz, president of BD Advanced Patient Monitoring. “These AI-driven enhancements of advanced algorithms and machine learning provide clinicians with more insights and clinical decision support to help improve the quality of care for their patients.”
The HemoSphere Alta™ platform also boasts an enhanced design that improves the user experience. It features a larger 15-inch high-resolution, customizable touchscreen display with split-screen views, enabling clinicians to view multiple parameters simultaneously. The design minimizes disruptive pop-ups, creating a smoother, less interrupted workflow. Additionally, the platform includes voice and gesture command capabilities, allowing clinicians to maintain sterility and interact hands-free with the monitor. This functionality supports tasks such as silencing alarms and switching views, making the platform both intuitive and efficient in fast-paced clinical environments. These improvements further optimize the platform’s usability, helping clinicians focus more on patient care.
According to DelveInsight’s “Hemodynamic Monitoring Systems Market Report,” the hemodynamic Monitoring Systems market was valued at USD 982 million in 2023, growing at a CAGR of 6.29% during the forecast period from 2024 to 2030, to reach USD 1,416 million by 2030. The Hemodynamic Monitoring Systems market is witnessing a positive market growth owing to factors such as the rising prevalence of cardiovascular diseases and diabetes, technological advancements in product development, an increasing geriatric population, a sedentary lifestyle, and increasing awareness programs regarding cardiovascular diseases.
On April 23, 2025, BD, a global leader in medical technology, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Phasix™ ST Umbilical Hernia Patch, the first and only fully absorbable hernia patch specifically designed for umbilical hernias. This innovative patch leverages the same surgical technique as permanent mesh procedures, offering clinicians a familiar approach while providing the unique benefits of complete absorption over time. With its commercial launch, the Phasix™ ST Umbilical Hernia Patch represents a significant advancement in hernia repair, providing an effective solution that supports healing and reduces the risk of long-term complications associated with permanent mesh materials.
The Phasix™ ST Umbilical Hernia Patch is composed of Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, enhanced with a proven hydrogel barrier based on Sepra® Technology. This unique combination provides an absorbable solution for umbilical hernia repair, offering both effective healing and reduced long-term complications. The patch can be deployed using the same surgical technique as traditional permanent mesh, providing surgeons with material flexibility and ease of use.
“I’ve been waiting and hoping for this product to come to market for many years, and I’m thrilled that it’s finally here for us to use,” said Dr. Robert Harrell, a general surgeon from Live Oak, Texas. “The combination of the unique features of the Ventralex™ ST Hernia Patch with the bioabsorbable nature of Phasix™ Mesh is a wonderful fusion of technology.
The Phasix™ ST patch features a pocket and strap design that facilitates easy placement, positioning, and lateral fixation, allowing for precise and reliable deployment. It is designed to replicate the form, function, and technique of the Ventralex™ ST Hernia Patch, a product family with over two million implants globally. This design ensures familiarity for clinicians while delivering an advanced, fully absorbable alternative for umbilical hernia repair.
According to DelveInsight’s “Hernia Repair Devices Market Report,” the hernia repair devices market was valued at USD 4 billion in 2023, growing at a CAGR of 5.08% during the forecast period from 2024 to 2030 to reach USD 5.38 billion by 2030. The increasing demand for hernia repair devices is primarily driven by the growing prevalence of hernias and the rising number of surgeries performed for their treatment. Key factors contributing to the positive growth of the hernia repair devices market during the forecast period from 2024 to 2030 include heightened research and development activities, along with technological advancements in device innovation.
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