Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jul 24, 2025
Table of Contents
On July 21, 2025, Medtronic plc., a global medical technology leader, secured the CE Mark in Europe to allow the MiniMed™ 780G system to be used in children as young as 2 years old, pregnant women, and individuals with insulin-requiring type 2 diabetes. The approval followed a review of published clinical studies involving toddlers, expectant mothers, and type 2 diabetes patients. This regulatory milestone reflected Medtronic’s dedication to broadening access to advanced automated insulin delivery (AID) solutions to enhance outcomes and the quality of life for a more inclusive range of diabetes patients across all life stages.
Data from the LENNY trial, which was recently published in The Lancet Diabetes & Endocrinology, demonstrated the safety and efficacy of the MiniMed™ 780G system in children aged 2–6 years with type 1 diabetes (T1D). Participants in the multicenter, randomized controlled, crossover trial achieved a 0.6% lower HbA1C and a 9.9% higher time in range (TIR) when the system was used in auto mode, compared to manual mode. Parents and caregivers reported improved sleep quality and a reduced fear of hypoglycemia when the device operated in auto mode.
Click Here To Get the Article in PDF
“As a parent, nothing is more important than giving my child the freedom to just be a kid but managing type 1 diabetes made that feel nearly impossible,” said Paul Schulz, based in Barcelona, Spain, whose son Marc lives with type 1 diabetes. “Ever since Marc was diagnosed with diabetes at age 4, we have been lucky to count on support from Medtronic. This doesn’t mean it has always been easy, but since starting the MiniMed™ 780G system, so much has changed. It’s like we’ve gained a teammate, one that works around the clock to help manage his diabetes. It’s very freeing.”
Automated insulin delivery (AID) systems rapidly became the standard of care for children with type 1 diabetes across Europe. In England and Wales, NICE guidelines (TA943) recommended hybrid closed-loop systems for all children and adolescents with T1D. Recognizing the importance of AID therapy, NHS England developed a 5-year plan to roll out AID systems to most people with T1D, prioritizing children up to the age of 18 years due to their high need for optimized care. The 2023 guidelines from the German Diabetes Association advised offering AID to all pediatric patients, provided they or their caregivers were able to use the technology safely. Additionally, the 2024 ISPAD guidelines strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care, especially overnight.
“Advancements in Automated Insulin Delivery (AID) systems are revolutionizing how we care for children with type 1 diabetes,” said Dr. Fiona Campbell, a leading pediatric endocrinologist in the UK. “For families, these systems lift the relentless burden of constant monitoring and insulin adjustments. Better glucose control in children can support healthier growth and brain development, better sleep, and the freedom to simply enjoy being a child. It’s a transformative shift in both outcomes and quality of life.”
Pregnancy posed unique challenges for women with type 1 diabetes due to hormonal and physiological changes, increasing the complexity of glucose management. To safeguard both mother and baby, guidelines had recommended tighter glucose targets Pregnancy Time in Range (TIRp) between 63 and 140 mg/dL. The MiniMed™ 780G system played a key role in achieving tighter control, with its ability to target glucose as low as 100 mg/dL. In a European study, pregnant women using the system achieved an average TIRp of 66.5%, with improved overnight control, reduced hypoglycemia, and greater treatment satisfaction. These findings supported guidelines from European and U.S. endocrine societies advocating for AID system use during pregnancy.
Additionally, the MiniMed™ 780G system was approved in Europe for people with type 2 diabetes. A pivotal trial showed a 0.7% reduction in HbA1c and increased TIR to 80%, while real-world data from over 26,000 users demonstrated sustained glycemic control. In the U.S., Medtronic had submitted the system for FDA review for type 2 diabetes use and launched trials for children aged 2–6 years.
As per DelveInsight’s “Insulin Delivery Device Market Report”, the global 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 July 15, 2025, RIVANNA®, developers of world-first imaging-based medical technologies, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This clearance authorized the use of both technologies in U.S. hospitals and clinical settings to provide anatomical guidance during needle or catheter placement.
The Accuro 3S was a portable, point-of-care ultrasound system featuring a proprietary Dual-Array™ convex probe and integrated SpineNav-AI software. The Dual-Array probe consisted of two aligned transducer arrays positioned side by side with a narrow gap, enabling an in-line needle approach through the center of the probe. The system combined images from both arrays to enhance anatomical visualization. It supported standard B-mode imaging and featured a touchscreen interface, a maneuverable cart-based design, and healthcare IT connectivity to implement DICOM-based patient and image archival workflows.
SpineNav-AI was a machine learning-based software solution designed to facilitate musculoskeletal imaging assessments of the lumbar spine and to support real-time visualization during anesthesia procedures. It provided automated landmark detection and identification of critical spinal anatomy, assisting clinicians by standardizing interpretation of spinal images. The software used an AI-based image processing architecture to identify key anatomical structures in ultrasound images and indicated the position of the spine midline. When the epidural space was detected, SpineNav-AI displayed the location and measured the depth to the epidural space.
“Achieving 510(k) clearance for Accuro 3S and SpineNav-AI ahead of schedule marks a significant milestone for RIVANNA and demonstrates the strength of our engineering and clinical partnerships. We are excited to introduce this next-generation platform to the market and continue advancing innovation in image-guided anesthesia procedures,” said Will Mauldin, PhD, RIVANNA Co-founder and CEO.
The Accuro 3S platform expanded upon RIVANNA’s proven history of improving first-attempt success rates in spinal procedures. It introduced advanced imaging features and integrated software tools to enhance the accuracy and efficiency of neuraxial anesthesia. RIVANNA also implemented consumable products, such as the Probe Cover Needle Guide Kit, to stabilize the probe and align the needle more effectively. This streamlined workflow allowed clinicians to locate the epidural space, determine its depth, and insert the needle with real-time visualization.
According to Mauldin, this innovation addressed long-standing challenges in procedural guidance. Traditional ultrasound-guided neuraxial procedures were hindered by the need to manage the needle, probe, and syringe simultaneously, steep needle angles that limited visibility, and difficulties in maintaining an in-plane view. RIVANNA’s solution overcame these barriers, improving accessibility, safety, and patient care.
The company moved forward with additional regulatory submissions and initiated clinical collaborations, beginning with a limited Accuro 3S release at select academic medical centers, followed by a wider market launch.
As per DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging Market Report”, the global artificial intelligence in medical imaging market was valued at USD 1.75 billion in 2023, growing at a CAGR of 30% during the forecast period from 2024 to 2030, to reach USD 8.56 billion by 2030. The rising burden of chronic diseases, such as cancer, cardiovascular disorders, and neurological conditions, is driving the demand for early and accurate diagnosis, thereby boosting the adoption of AI in medical imaging. Simultaneously, increased advancements in machine learning and deep learning algorithms have significantly enhanced image analysis, enabling faster, more precise, and automated interpretations. Moreover, the growing product development activities by key players and startups across the globe are leading to the introduction of innovative AI-powered imaging solutions. Collectively, these factors are accelerating the integration of AI technologies in medical imaging, improving diagnostic accuracy and workflow efficiency in healthcare settings.
On July 16, 2025, Medtronic, a global leader in healthcare technology, announced that the first patient had been enrolled in the PEripheral Onyx™ Liquid Embolic (PELE) clinical trial. The study aimed to evaluate the safety and effectiveness of the Onyx™ Liquid Embolic System (LES) for embolization of arterial hemorrhage in the peripheral vasculature. The first procedure was performed by Dr. Christopher Stark at Albany Medical Center.
The PELE IDE Clinical Study was designed to assess the safety and efficacy of the Onyx LES in treating patients with active arterial bleeding in the peripheral vasculature considered suitable for embolization. In the context of this study, peripheral vasculature referred to vessels located outside the brain and heart.
“Embolic agents are an important tool to address hemorrhage. In this case, the patient experienced bleeding due to a ruptured blood vessel following a routine medical procedure. Onyx LES was administered into the target vessel to successfully facilitate embolization,” said Christopher Stark, M.D., vascular and interventional radiologist at Albany Medical Center. “Albany Medical Center is proud to be enrolling patients in the PELE IDE Clinical Study, the aim of which is to gather evidence to support the safety and efficacy of Onyx LES in the treatment of peripheral arterial hemorrhage.”
“Onyx LES is available with a peripheral indication in many markets outside the U.S.,” said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “This trial will generate the evidence necessary for U.S. physicians to use Onyx for embolization of arterial hemorrhage in the peripheral vasculature, a key part of advancing our embolic portfolio strategy.”
The PELE IDE Clinical Study was built upon the extensive commercial experience gained from the global use of Onyx LES in the peripheral vasculature. It aimed to generate the necessary evidence to include Onyx LES in Medtronic’s U.S. portfolio of peripheral vasculature embolization products. In the United States, the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature remained investigational and had not yet been approved or cleared by the U.S. Food and Drug Administration.
As per DelveInsight’s “Peripheral Vascular Devices Market Report”, the global peripheral vascular devices market was valued at USD 9.63 billion in 2023, growing at a CAGR of 7.88% during the forecast period from 2024 to 2030, to reach USD 15.13 billion by 2030. The demand for peripheral vascular devices is primarily being boosted by the rising prevalence of cardiovascular diseases and peripheral vascular diseases, the approval of new and advanced products, and the rising incidence of lifestyle disorders such as diabetes and hypertension. Furthermore, the increase in the geriatric population is also likely to contribute to the growth of the peripheral vascular devices market.
On July 23, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics.
The BD Libertas™ Wearable Injector was selected for this pharma-sponsored trial following successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, including a device clinical study that demonstrated excellent performance, with 100% of study participants stating they would likely have used the BD Libertas™ Wearable Injector if prescribed.
The pharma-sponsored combination product clinical trial represented a significant advancement in accelerating innovation in drug-device combination products that provided greater flexibility for patients, including the potential conversion from infused medications requiring hospital or clinic visits to more convenient patient care in various settings, such as self-injection at home.
“This trial demonstrates BD’s commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient-friendly by offering more efficient and convenient options for biologics,” said Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems. “BD’s enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas™ Wearable Injector technology further position BD as an innovative leader in drug delivery.”
The BD Libertas™ Wearable Injector was an innovative, prefilled, and patient-ready drug delivery system designed to enable subcutaneous administration of complex biologics. As the biologics market was projected to exceed $670 billion by 2030, the BD Libertas™ Injector offered pharmaceutical companies a customizable and patient-centric solution. It supported the delivery of high-viscosity biologics (up to 50 centipoise), offered flexible volume configurations of 2–5 mL and 5–10 mL, and featured a fully mechanical design with a simple “peel, stick, and click” mechanism—eliminating the need for end-user assembly or filling. BD had also validated its fill-finish and final assembly processes with multiple Contract Manufacturing Organizations (CMOs), enabling support for pharmaceutical partners from product development through commercial-scale production.
According to DelveInsight’s “Biologics Drug Substance Manufacturing Market Report,” the biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologic drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.
On July 16, 2025, Olympus Corporation of the Americas, a global MedTech company dedicated to improving lives, announced the U.S. launch of the next-generation EU-ME3 Ultrasound Processor, which integrated endoscopic and endobronchial ultrasound (EUS/EBUS) into a single workstation. The EU-ME3 offered image quality and functionality comparable to a high-end ultrasound center, all within a compact design.
The versatile EU-ME3 supported diagnostic imaging and ultrasound-guided interventions for hepatobiliary-pancreatic and pulmonary procedures, and expanded the possibilities of endosonography with advanced features, high-resolution imaging, and intuitive operation.
To aid in the detection and characterization of lesions, the EU-ME3 delivered high image clarity for EUS and EBUS procedures. Imaging technologies like s-FOCUS and Tissue Harmonic Echo enabled consistent focusing throughout the depth of the field, enhanced resolution and signal-to-noise ratio, and reduced artifacts.
Smart user settings allowed healthcare professionals to tailor configurations to meet physician preferences and procedural demands.With backward and forward compatibility with Olympus® EUS and EBUS endoscopes and miniature probes, the processor proved adaptable and helped facilities improve cost efficiency across various specialties.
“As healthcare facilities look for ways to improve patient outcomes and save costs, we are pleased to offer our customers a versatile, state-of-the-art ultrasound platform for GI and pulmonary applications,” said Richard Reynolds, President of the Medical Systems Group at Olympus Corporation of the Americas. “The EU-ME3 allows physicians to realize clinical efficacy through premier imaging that supports early detection and diagnosis for patients.”
According to DelveInsight’s “Diagnostic Imaging Equipment Market Report”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2020, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancements, the growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, the growing demand for effective & efficient imaging technologies for diagnosis, and the increasing geriatric population.
On July 16, 2025, Thermo Fisher Scientific Inc., the world leader in serving science, announced the expansion of its strategic partnership with Sanofi to enable additional U.S. drug product manufacturing. The terms of the deal were not disclosed.
Under the agreement, Thermo Fisher acquired Sanofi’s sterile manufacturing site in Ridgefield, New Jersey, and continued to manufacture a portfolio of therapies for Sanofi. Additionally, Thermo Fisher expanded use of the site to meet the growing demand from pharma and biotech customers for U.S. manufacturing capacity. The Ridgefield site was a state-of-the-art sterile fill-finish and packaging facility with a world-class team of more than 200 employees who joined Thermo Fisher following the completion of the transaction.
“Sanofi’s Ridgefield site will strengthen our U.S. manufacturing capabilities, enabling us to better support our pharmaceutical and biotech customers with the critical production capacity needed for essential medicines,” said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher. “We will also expand and further strengthen our long-standing partnership with Sanofi, while investing to bring additional capacity and enhanced capabilities at this site. We look forward to welcoming all Ridgefield employees to Thermo Fisher later this year.”
Thermo Fisher operates a leading global sterile fill-finish manufacturing network, which currently includes U.S. sites in Greenville, North Carolin, and Plainville, Massachusetts. These sites are integral to the company’s Accelerator™ Drug Development 360° CDMO and CRO solutions, transforming the pharmaceutical value chain for emerging biotech and biopharma companies to speed life-changing medicines to patients.
The transaction was expected to be completed in the second half of 2025, subject to customary closing conditions. Upon completion of the transaction, Sanofi’s Ridgefield facility will become part of Thermo Fisher’s pharma services business within its Laboratory Products and Biopharma Services segment.
As per DelveInsight’s “Pharmaceutical Contract Manufacturing Market Report,” the cochlear implants market was valued at USD 99 billion in 2023, growing at a CAGR of 4.2% during the forecast period from 2024 to 2030 to reach USD 140 billion by 2030. The pharmaceutical contract manufacturing market is primarily driven by increasing demand for cost-effective drug production, rising outsourcing trends among pharmaceutical companies, and the growing complexity of biologics and specialty drugs that require advanced manufacturing capabilities. Additionally, the need to reduce time-to-market, expanding global pharmaceutical pipelines, and a strong focus on core competencies by drug developers are fueling the growth. Regulatory support for outsourced manufacturing and capacity constraints of small to mid-sized pharma companies further accelerate market expansion.
Article in PDF
Jul 24, 2025
Table of Contents
On July 21, 2025, Medtronic plc., a global medical technology leader, secured the CE Mark in Europe to allow the MiniMed™ 780G system to be used in children as young as 2 years old, pregnant women, and individuals with insulin-requiring type 2 diabetes. The approval followed a review of published clinical studies involving toddlers, expectant mothers, and type 2 diabetes patients. This regulatory milestone reflected Medtronic’s dedication to broadening access to advanced automated insulin delivery (AID) solutions to enhance outcomes and the quality of life for a more inclusive range of diabetes patients across all life stages.
Data from the LENNY trial, which was recently published in The Lancet Diabetes & Endocrinology, demonstrated the safety and efficacy of the MiniMed™ 780G system in children aged 2–6 years with type 1 diabetes (T1D). Participants in the multicenter, randomized controlled, crossover trial achieved a 0.6% lower HbA1C and a 9.9% higher time in range (TIR) when the system was used in auto mode, compared to manual mode. Parents and caregivers reported improved sleep quality and a reduced fear of hypoglycemia when the device operated in auto mode.
“As a parent, nothing is more important than giving my child the freedom to just be a kid but managing type 1 diabetes made that feel nearly impossible,” said Paul Schulz, based in Barcelona, Spain, whose son Marc lives with type 1 diabetes. “Ever since Marc was diagnosed with diabetes at age 4, we have been lucky to count on support from Medtronic. This doesn’t mean it has always been easy, but since starting the MiniMed™ 780G system, so much has changed. It’s like we’ve gained a teammate, one that works around the clock to help manage his diabetes. It’s very freeing.”
Automated insulin delivery (AID) systems rapidly became the standard of care for children with type 1 diabetes across Europe. In England and Wales, NICE guidelines (TA943) recommended hybrid closed-loop systems for all children and adolescents with T1D. Recognizing the importance of AID therapy, NHS England developed a 5-year plan to roll out AID systems to most people with T1D, prioritizing children up to the age of 18 years due to their high need for optimized care. The 2023 guidelines from the German Diabetes Association advised offering AID to all pediatric patients, provided they or their caregivers were able to use the technology safely. Additionally, the 2024 ISPAD guidelines strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care, especially overnight.
“Advancements in Automated Insulin Delivery (AID) systems are revolutionizing how we care for children with type 1 diabetes,” said Dr. Fiona Campbell, a leading pediatric endocrinologist in the UK. “For families, these systems lift the relentless burden of constant monitoring and insulin adjustments. Better glucose control in children can support healthier growth and brain development, better sleep, and the freedom to simply enjoy being a child. It’s a transformative shift in both outcomes and quality of life.”
Pregnancy posed unique challenges for women with type 1 diabetes due to hormonal and physiological changes, increasing the complexity of glucose management. To safeguard both mother and baby, guidelines had recommended tighter glucose targets Pregnancy Time in Range (TIRp) between 63 and 140 mg/dL. The MiniMed™ 780G system played a key role in achieving tighter control, with its ability to target glucose as low as 100 mg/dL. In a European study, pregnant women using the system achieved an average TIRp of 66.5%, with improved overnight control, reduced hypoglycemia, and greater treatment satisfaction. These findings supported guidelines from European and U.S. endocrine societies advocating for AID system use during pregnancy.
Additionally, the MiniMed™ 780G system was approved in Europe for people with type 2 diabetes. A pivotal trial showed a 0.7% reduction in HbA1c and increased TIR to 80%, while real-world data from over 26,000 users demonstrated sustained glycemic control. In the U.S., Medtronic had submitted the system for FDA review for type 2 diabetes use and launched trials for children aged 2–6 years.
As per DelveInsight’s “Insulin Delivery Device Market Report”, the global 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 July 15, 2025, RIVANNA®, developers of world-first imaging-based medical technologies, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This clearance authorized the use of both technologies in U.S. hospitals and clinical settings to provide anatomical guidance during needle or catheter placement.
The Accuro 3S was a portable, point-of-care ultrasound system featuring a proprietary Dual-Array™ convex probe and integrated SpineNav-AI software. The Dual-Array probe consisted of two aligned transducer arrays positioned side by side with a narrow gap, enabling an in-line needle approach through the center of the probe. The system combined images from both arrays to enhance anatomical visualization. It supported standard B-mode imaging and featured a touchscreen interface, a maneuverable cart-based design, and healthcare IT connectivity to implement DICOM-based patient and image archival workflows.
SpineNav-AI was a machine learning-based software solution designed to facilitate musculoskeletal imaging assessments of the lumbar spine and to support real-time visualization during anesthesia procedures. It provided automated landmark detection and identification of critical spinal anatomy, assisting clinicians by standardizing interpretation of spinal images. The software used an AI-based image processing architecture to identify key anatomical structures in ultrasound images and indicated the position of the spine midline. When the epidural space was detected, SpineNav-AI displayed the location and measured the depth to the epidural space.
“Achieving 510(k) clearance for Accuro 3S and SpineNav-AI ahead of schedule marks a significant milestone for RIVANNA and demonstrates the strength of our engineering and clinical partnerships. We are excited to introduce this next-generation platform to the market and continue advancing innovation in image-guided anesthesia procedures,” said Will Mauldin, PhD, RIVANNA Co-founder and CEO.
The Accuro 3S platform expanded upon RIVANNA’s proven history of improving first-attempt success rates in spinal procedures. It introduced advanced imaging features and integrated software tools to enhance the accuracy and efficiency of neuraxial anesthesia. RIVANNA also implemented consumable products, such as the Probe Cover Needle Guide Kit, to stabilize the probe and align the needle more effectively. This streamlined workflow allowed clinicians to locate the epidural space, determine its depth, and insert the needle with real-time visualization.
According to Mauldin, this innovation addressed long-standing challenges in procedural guidance. Traditional ultrasound-guided neuraxial procedures were hindered by the need to manage the needle, probe, and syringe simultaneously, steep needle angles that limited visibility, and difficulties in maintaining an in-plane view. RIVANNA’s solution overcame these barriers, improving accessibility, safety, and patient care.
The company moved forward with additional regulatory submissions and initiated clinical collaborations, beginning with a limited Accuro 3S release at select academic medical centers, followed by a wider market launch.
As per DelveInsight’s “Artificial Intelligence (AI) in Medical Imaging Market Report”, the global artificial intelligence in medical imaging market was valued at USD 1.75 billion in 2023, growing at a CAGR of 30% during the forecast period from 2024 to 2030, to reach USD 8.56 billion by 2030. The rising burden of chronic diseases, such as cancer, cardiovascular disorders, and neurological conditions, is driving the demand for early and accurate diagnosis, thereby boosting the adoption of AI in medical imaging. Simultaneously, increased advancements in machine learning and deep learning algorithms have significantly enhanced image analysis, enabling faster, more precise, and automated interpretations. Moreover, the growing product development activities by key players and startups across the globe are leading to the introduction of innovative AI-powered imaging solutions. Collectively, these factors are accelerating the integration of AI technologies in medical imaging, improving diagnostic accuracy and workflow efficiency in healthcare settings.
On July 16, 2025, Medtronic, a global leader in healthcare technology, announced that the first patient had been enrolled in the PEripheral Onyx™ Liquid Embolic (PELE) clinical trial. The study aimed to evaluate the safety and effectiveness of the Onyx™ Liquid Embolic System (LES) for embolization of arterial hemorrhage in the peripheral vasculature. The first procedure was performed by Dr. Christopher Stark at Albany Medical Center.
The PELE IDE Clinical Study was designed to assess the safety and efficacy of the Onyx LES in treating patients with active arterial bleeding in the peripheral vasculature considered suitable for embolization. In the context of this study, peripheral vasculature referred to vessels located outside the brain and heart.
“Embolic agents are an important tool to address hemorrhage. In this case, the patient experienced bleeding due to a ruptured blood vessel following a routine medical procedure. Onyx LES was administered into the target vessel to successfully facilitate embolization,” said Christopher Stark, M.D., vascular and interventional radiologist at Albany Medical Center. “Albany Medical Center is proud to be enrolling patients in the PELE IDE Clinical Study, the aim of which is to gather evidence to support the safety and efficacy of Onyx LES in the treatment of peripheral arterial hemorrhage.”
“Onyx LES is available with a peripheral indication in many markets outside the U.S.,” said David Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “This trial will generate the evidence necessary for U.S. physicians to use Onyx for embolization of arterial hemorrhage in the peripheral vasculature, a key part of advancing our embolic portfolio strategy.”
The PELE IDE Clinical Study was built upon the extensive commercial experience gained from the global use of Onyx LES in the peripheral vasculature. It aimed to generate the necessary evidence to include Onyx LES in Medtronic’s U.S. portfolio of peripheral vasculature embolization products. In the United States, the use of Onyx LES for embolization of arterial hemorrhage in the peripheral vasculature remained investigational and had not yet been approved or cleared by the U.S. Food and Drug Administration.
As per DelveInsight’s “Peripheral Vascular Devices Market Report”, the global peripheral vascular devices market was valued at USD 9.63 billion in 2023, growing at a CAGR of 7.88% during the forecast period from 2024 to 2030, to reach USD 15.13 billion by 2030. The demand for peripheral vascular devices is primarily being boosted by the rising prevalence of cardiovascular diseases and peripheral vascular diseases, the approval of new and advanced products, and the rising incidence of lifestyle disorders such as diabetes and hypertension. Furthermore, the increase in the geriatric population is also likely to contribute to the growth of the peripheral vascular devices market.
On July 23, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics.
The BD Libertas™ Wearable Injector was selected for this pharma-sponsored trial following successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, including a device clinical study that demonstrated excellent performance, with 100% of study participants stating they would likely have used the BD Libertas™ Wearable Injector if prescribed.
The pharma-sponsored combination product clinical trial represented a significant advancement in accelerating innovation in drug-device combination products that provided greater flexibility for patients, including the potential conversion from infused medications requiring hospital or clinic visits to more convenient patient care in various settings, such as self-injection at home.
“This trial demonstrates BD’s commitment to helping pharma companies by advancing large-volume injection science, ensuring therapies are accessible and patient-friendly by offering more efficient and convenient options for biologics,” said Patrick Jeukenne, worldwide president of BD Pharmaceutical Systems. “BD’s enhanced testing capabilities acquired through ZebraSci and the proven capabilities of the BD Libertas™ Wearable Injector technology further position BD as an innovative leader in drug delivery.”
The BD Libertas™ Wearable Injector was an innovative, prefilled, and patient-ready drug delivery system designed to enable subcutaneous administration of complex biologics. As the biologics market was projected to exceed $670 billion by 2030, the BD Libertas™ Injector offered pharmaceutical companies a customizable and patient-centric solution. It supported the delivery of high-viscosity biologics (up to 50 centipoise), offered flexible volume configurations of 2–5 mL and 5–10 mL, and featured a fully mechanical design with a simple “peel, stick, and click” mechanism—eliminating the need for end-user assembly or filling. BD had also validated its fill-finish and final assembly processes with multiple Contract Manufacturing Organizations (CMOs), enabling support for pharmaceutical partners from product development through commercial-scale production.
According to DelveInsight’s “Biologics Drug Substance Manufacturing Market Report,” the biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologic drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.
On July 16, 2025, Olympus Corporation of the Americas, a global MedTech company dedicated to improving lives, announced the U.S. launch of the next-generation EU-ME3 Ultrasound Processor, which integrated endoscopic and endobronchial ultrasound (EUS/EBUS) into a single workstation. The EU-ME3 offered image quality and functionality comparable to a high-end ultrasound center, all within a compact design.
The versatile EU-ME3 supported diagnostic imaging and ultrasound-guided interventions for hepatobiliary-pancreatic and pulmonary procedures, and expanded the possibilities of endosonography with advanced features, high-resolution imaging, and intuitive operation.
To aid in the detection and characterization of lesions, the EU-ME3 delivered high image clarity for EUS and EBUS procedures. Imaging technologies like s-FOCUS and Tissue Harmonic Echo enabled consistent focusing throughout the depth of the field, enhanced resolution and signal-to-noise ratio, and reduced artifacts.
Smart user settings allowed healthcare professionals to tailor configurations to meet physician preferences and procedural demands.With backward and forward compatibility with Olympus® EUS and EBUS endoscopes and miniature probes, the processor proved adaptable and helped facilities improve cost efficiency across various specialties.
“As healthcare facilities look for ways to improve patient outcomes and save costs, we are pleased to offer our customers a versatile, state-of-the-art ultrasound platform for GI and pulmonary applications,” said Richard Reynolds, President of the Medical Systems Group at Olympus Corporation of the Americas. “The EU-ME3 allows physicians to realize clinical efficacy through premier imaging that supports early detection and diagnosis for patients.”
According to DelveInsight’s “Diagnostic Imaging Equipment Market Report”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2020, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancements, the growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, the growing demand for effective & efficient imaging technologies for diagnosis, and the increasing geriatric population.
On July 16, 2025, Thermo Fisher Scientific Inc., the world leader in serving science, announced the expansion of its strategic partnership with Sanofi to enable additional U.S. drug product manufacturing. The terms of the deal were not disclosed.
Under the agreement, Thermo Fisher acquired Sanofi’s sterile manufacturing site in Ridgefield, New Jersey, and continued to manufacture a portfolio of therapies for Sanofi. Additionally, Thermo Fisher expanded use of the site to meet the growing demand from pharma and biotech customers for U.S. manufacturing capacity. The Ridgefield site was a state-of-the-art sterile fill-finish and packaging facility with a world-class team of more than 200 employees who joined Thermo Fisher following the completion of the transaction.
“Sanofi’s Ridgefield site will strengthen our U.S. manufacturing capabilities, enabling us to better support our pharmaceutical and biotech customers with the critical production capacity needed for essential medicines,” said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher. “We will also expand and further strengthen our long-standing partnership with Sanofi, while investing to bring additional capacity and enhanced capabilities at this site. We look forward to welcoming all Ridgefield employees to Thermo Fisher later this year.”
Thermo Fisher operates a leading global sterile fill-finish manufacturing network, which currently includes U.S. sites in Greenville, North Carolin, and Plainville, Massachusetts. These sites are integral to the company’s Accelerator™ Drug Development 360° CDMO and CRO solutions, transforming the pharmaceutical value chain for emerging biotech and biopharma companies to speed life-changing medicines to patients.
The transaction was expected to be completed in the second half of 2025, subject to customary closing conditions. Upon completion of the transaction, Sanofi’s Ridgefield facility will become part of Thermo Fisher’s pharma services business within its Laboratory Products and Biopharma Services segment.
As per DelveInsight’s “Pharmaceutical Contract Manufacturing Market Report,” the cochlear implants market was valued at USD 99 billion in 2023, growing at a CAGR of 4.2% during the forecast period from 2024 to 2030 to reach USD 140 billion by 2030. The pharmaceutical contract manufacturing market is primarily driven by increasing demand for cost-effective drug production, rising outsourcing trends among pharmaceutical companies, and the growing complexity of biologics and specialty drugs that require advanced manufacturing capabilities. Additionally, the need to reduce time-to-market, expanding global pharmaceutical pipelines, and a strong focus on core competencies by drug developers are fueling the growth. Regulatory support for outsourced manufacturing and capacity constraints of small to mid-sized pharma companies further accelerate market expansion.
