Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jul 10, 2025
Table of Contents
On July 02, 2025, Intuitive, widely recognized as a pioneer in robotic-assisted surgery and minimally invasive care, announced that its latest system, the da Vinci 5, had secured CE mark approval for use in both adult and pediatric patients across Europe. This approval enabled its application in a broad range of endoscopic procedures, including abdominopelvic and thoracoscopic surgeries such as urologic, gynecologic, and general laparoscopic operations.
As Intuitive’s most advanced multiport robotic-assisted system, the da Vinci 5 had built upon the proven capabilities of the da Vinci Xi, incorporating over 150 new enhancements. By the time of approval, da Vinci systems had already been used in over 410,000 procedures across Europe in 2024, contributing to nearly 17 million surgeries performed globally since their introduction.
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“We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe,” said Intuitive Chief Executive Officer Dave Rosa.
“At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future. After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created, designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care,” said Rosa.
The da Vinci 5 was developed to transform surgical care by offering enhanced sensory and operational capabilities. It introduced Force Feedback technology, a first for the platform, along with the most realistic 3D visualization system and an ergonomic console designed to improve the surgeon’s experience and extend career longevity.
To boost operational efficiency, the system incorporated tools that surgeons could manage directly, simplified the learning process with an intuitive design, and introduced a unified interface for care teams. Built-in dynamic assistance helped automate specific tasks, further improving surgical workflow.
Additionally, the system was powered by a highly intelligent platform that offered massively increased computing power, along with advanced sensors and processors. These innovations enabled the collection of detailed, actionable data, helping surgeons to better assess and continuously improve their surgical performance and patient care.
“We believe that the operational efficiencies and actionable insights provided by da Vinci 5 will not only help transform surgery but also help address critical challenges faced by healthcare systems across Europe,” said Dirk Barten, Intuitive’s senior vice president and general manager for Europe.
“It’s exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving them greater choice and flexibility, and ultimately supporting quality care for more patients across the region,” said Barten.
As per DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On June 07, 2025, the U.S. FDA granted Boston Scientific Corporation (NYSE: BSX) approval to expand the use instructions for its FARAPULSE™ Pulsed Field Ablation (PFA) System. This updated approval allowed the system to be used for treating patients with drug-refractory, symptomatic persistent atrial fibrillation (AF), a chronic arrhythmia marked by abnormal heart rhythms lasting over seven days.
Persistent AF, which affects millions globally, often leads to symptoms like fatigue, dizziness, and breathlessness, while significantly raising stroke risk. The FARAPULSE PFA System has been used to treat AF by delivering precise pulses of energy through a catheter to ablate affected cardiac tissue. As part of the updated labeling, both the FARAWAVE™ and FARAWAVE NAV™ PFA Catheters were cleared for use in treating this more challenging form of AF.
“Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies,” said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”
The FDA’s approval for expanded labeling was supported by clinical data from phase one of the ADVANTAGE AF clinical trial, which had been presented at the AF Symposium 2025 and published in the Journal of the American College of Cardiology. The study met both primary safety and effectiveness endpoints. In this prospective, single-arm trial, 260 patients who had shown intolerance to at least one Class I or III anti-arrhythmic drug (AAD) were enrolled across 43 global sites. No incidents of stroke, pulmonary vein stenosis, atrio-esophageal fistula, or major access complications were reported. The rate of symptomatic AF recurrence-free survival stood at 85.3%. Observationally, among physicians who had conducted three or more procedures, this rate rose to 91.4%.
Boston Scientific had anticipated obtaining the CE mark, as well as regulatory approvals in Japan and China, in the months following the FDA approval. The company also launched the ReMATCH IDE clinical trial, enrolling approximately 375 patients across 40 centers in the U.S. and Asia. The trial was designed to assess the safety and effectiveness of the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AF who had previously undergone ablation using PFA, radiofrequency, or cryoablation technologies and experienced recurrence. The study also included evaluation of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus ablation and left atrial ablation of the mitral isthmus within the same patient population.
As per DelveInsight’s “Ablation Devices Market Report”, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2024 to 2030. Factors such as the increasing incidence of cancers, such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmia such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
On July 07, 2025, Trividia Health, Inc. announced that its TRUE METRIX® Self-Monitoring Blood Glucose Systems had been designated as preferred on all Managed Medicaid Plans and Fee-for-Service Medicaid in Pennsylvania, effective July 7, 2025. The TRUE METRIX® portfolio has delivered high performance rooted in scientific research and continuous technological advancements. Its test strips featured TRIPLE SENSE TECHNOLOGY®, ensuring clinical accuracy and confidence in blood glucose results.
The TRUE METRIX Test Strips were manufactured in the United States at the company’s facilities in Fort Lauderdale, Florida. Trividia Health had been recognized as the largest U.S. manufacturer of pharmacy-branded products for individuals with diabetes. For over 40 years, Trividia Health has remained committed to advancing diabetes care. The company had focused on developing innovative and affordable solutions to help millions of people manage their blood glucose levels effectively.
“Alongside our pharmacy and distribution partners, Trividia Health’s priority is providing accessibility through national coverage with a local presence. Having the TRUE METRIX Self-Monitoring Blood Glucose Meters and Test Strips as preferred products within Pennsylvania allows patients the ability to test with confidence and manage their diabetes,” said Jonathan Chapman, President and CEO of Trividia Health.
As per DelveInsight’s “Blood Glucose Monitoring Systems Market Report”, the blood glucose monitoring systems market was valued at USD 12.12 billion in 2024, growing at a CAGR of 7.72% during the forecast period from 2024 to 2030 to reach USD 18.89 billion by 2030. The blood glucose monitoring systems market is expanding rapidly due to the rising prevalence of lifestyle style disorders such as diabetes and impaired glucose tolerance, growing product launches and approvals by key players, and a rising preference for minimally invasive techniques that are expected to significantly drive the demand for blood glucose monitoring systems from 2024 to 2030.
On July 08, 2025, Cerapedics Inc., a global commercial-stage orthopedics company focused on redefining bone repair, announced the successful completion of the first patient treatment with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following its recent approval by the U.S. Food and Drug Administration (FDA). The PearlMatrix Bone Graft, a Class III drug-device combination product designed for lumbar fusion, was used in a post-approval procedure on an adult patient with degenerative disc disease (DDD). The surgery was performed by Dr. Sharad Rajpal, Medical Director of the Advanced Spine Program at AdventHealth Avista in Louisville, Colorado.
PearlMatrix Bone Graft had received FDA premarket approval in June 2025 and became the first and only bone growth accelerator shown to enhance lumbar fusion based on findings from the pivotal ASPIRE IDE study. Among more than 350 spinal bone grafts available in the U.S. market, Cerapedics had developed two of the only three that had successfully passed through the PMA (Premarket Approval) process.
“My goal is to bring my patients the most innovative and appropriate treatments specific to their needs, so they can regain their quality of life as soon as possible. I am proud to have performed the first post-approval procedure using PearlMatrix Bone Graft, a novel approach to treating degenerative disc disease,” said Sharad Rajpal, M.D., FAANS, FCNS, with AHMG. “It’s innovation like this that helps surgeons effectively treat patients, and it’s particularly gratifying to be able to use a Colorado innovation on a local resident.”
“This first surgery post-approval is a significant milestone for Cerapedics,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “Every single team member behind the development, approval, and distribution of PearlMatrix P-15 Peptide Enhanced Bone Graft worked tirelessly to get this unique drug-device into the hands of surgeons to help them safely and effectively treat their patients. We are proud of the innovation we bring to the market, and we look forward to seeing the positive impact of our devices.”
According to DelveInsight’s “Bone Graft and Substitute Market Report”, the bone graft and substitutes market was valued at USD 3,786.25 million in 2024, growing at a CAGR of 5.88% during the forecast period from 2025 to 2032 to reach USD 5,957.71 million by 2032. The increasing prevalence of bone-related disorders and trauma cases, coupled with a rising demand for bone grafts in dentistry, is significantly boosting the global market for bone grafts and substitutes. As bone diseases such as osteoporosis and bone fractures become more common, particularly among the aging population, the need for effective bone regeneration and repair solutions has surged. The growing geriatric population, which is more prone to bone degeneration, fractures, and joint issues, further drives demand for bone grafts, especially in orthopedic and dental procedures. Additionally, the increase in product development activities, with innovations in synthetic, allograft, and xenograft materials, is enhancing the effectiveness and availability of bone graft substitutes. These factors collectively contribute to the expansion of the bone graft and substitutes market, with more advanced, biocompatible, and cost-effective solutions being introduced to meet the rising demand during the forecast period from 2025 to 2032.
On July 7, 2025, Smith+Nephew, the global medical technology company, announced the release of its Q-FIX KNOTLESS All-Suture Anchor for soft tissue-to-bone fixation across multiple joint spaces, including the shoulder, hip, and foot & ankle. Building upon the established success of the Q-FIX Family, which had demonstrated best-in-class anchor fixation strength compared to competing devices, the Q-FIX KNOTLESS system raised the bar in all-suture anchor technology.
The device introduced proprietary features designed to deliver market-leading fixation strength, ultra-low displacement, and consistent deployment. It offered best-in-class soft tissue security through a secure suture lock mechanism, along with streamlined suture shuttling. The anchor also achieved market-leading biomechanical performance, including the lowest displacement during cyclic loading.
Additionally, the Q-FIX KNOTLESS system has provided surgeons with a range of suture options, including the single-loaded MINITAPE◊ Suture Tape, known for its low profile and even pressure distribution, and the ULTRABRAID◊ #2 Suture, which has proven to be 20% stronger than its nearest competitor.
“When I think of the Q-FIX family, I think of reliability,” commented Dr. Robert Litchfield, Orthopedic Surgeon, Sports Medicine Ontario, Canada. “We know that when we put a Q-FIX Anchor in, that we can count on it – the deployment is always predictable and the pullouts are impressive. In my experience, these anchors just don’t fail when we puta load on them.”
According to DelveInsight’s “Internal Trauma Fixation Devices Market Report”, the global internal trauma fixation devices market was valued at USD 9.52 billion in 2023, growing at a CAGR of 7.03% during the forecast period from 2024 to 2030 to reach USD 14.32 billion by 2030. The Internal Trauma Fixation Devices market is witnessing positive growth owing to the rising number of trauma and accident cases, increase in the prevalence of degenerative bone disorders, a growing number of sports-related injuries, technological innovation in product development, thereby contributing to the growth of the Internal Trauma Fixation Devices market during the forecast period from 2024 to 2030.
On July 08, 2025, Cochlear Limited, the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval of the Cochlear™ Nucleus® Nexa™ System, the world’s first and only smart cochlear implant system.
Previously, cochlear implant recipients could only access new technology through the external sound processor and typically needed a replacement processor to experience technological advancements. The newly launched Nexa System introduced upgradeable implant firmware, which, for the first time, allowed recipients to benefit from future innovations through both their implant and sound processor. This firmware update pathway was designed to improve sound processor upgrades and enhance the overall hearing experience, offering more flexible access to innovation over time.
Additionally, the Nucleus 8 Nexa Sound Processor with the Power Compact rechargeable battery was recognized as the smallest and lightest sound processor on the market with all-day battery life. A new implant-based algorithm, Dynamic Power Management, enabled the system to respond intuitively to users’ needs throughout the day while optimizing power efficiency. The processor was 9% smaller and 12% lighter than its predecessor, the Nucleus 8 with Power Extend, giving users the benefit of all-day hearing in a more compact, comfortable device.
“The Nucleus Nexa Implant is the first ever cochlear implant running its own firmware. Similar to smartphones, the implant firmware can be updated to enable new features and access future innovations. Recipients will now have access to their best possible hearing experience with both implant and sound processor updates. The Nucleus Nexa System builds upon Cochlear’s industry-leading portfolio of electrodes, which are designed to optimize the electrode-neural interface and protect cochlear health for a lifetime of hearing performance, and opens the door to even greater hearing potential for patients into the future. While it uses the same implant form factor as the most reliable cochlear implant in the industry, the new Nexa Implant features a totally new and redesigned chipset packed with innovative and smart features. This includes onboard diagnostics, which takes the pressure off carers and recipients by allowing the system to check itself and monitor to ensure it is performing to the best of the recipient’s hearing needs. This new system sets a new industry standard,” Jan Janssen, Chief Technology Officer at Cochlear, said.
The Nucleus Nexa Implant became the first cochlear implant with internal memory, enabling secure storage of personalized hearing settings (MAPs) within the implant itself. These settings could be easily transferred to any Nucleus Nexa Sound Processor in the future, helping recipients stay connected to sound even if their external processor was lost or damaged. The new system included the Nucleus Nexa Implant, the Nucleus Kanso 3 Nexa Sound Processor, and the Nucleus 8 Nexa Sound Processor. These devices were supported by an integrated ecosystem of tools designed to optimize patient outcomes, including Nucleus SmartNav, Nucleus Smart App, Custom Sound® Pro fitting software, and wireless accessories. Additionally, individuals with legacy Cochlear Nucleus Systems had been given the option to upgrade to the Kanso 3 Sound Processor. Both the Kanso 3 Nexa and Kanso 3 Sound Processors offered the full range of innovations introduced with the Nucleus 8, such as SmartSound iQ 2 with SCAN2† and automated ForwardFocus.As per DelveInsight’s “Cochlear Implants Market Report, the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs, investing in cochlear implants & improving access to these devices and supportive reimbursement policies are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
Article in PDF
Jul 10, 2025
Table of Contents
On July 02, 2025, Intuitive, widely recognized as a pioneer in robotic-assisted surgery and minimally invasive care, announced that its latest system, the da Vinci 5, had secured CE mark approval for use in both adult and pediatric patients across Europe. This approval enabled its application in a broad range of endoscopic procedures, including abdominopelvic and thoracoscopic surgeries such as urologic, gynecologic, and general laparoscopic operations.
As Intuitive’s most advanced multiport robotic-assisted system, the da Vinci 5 had built upon the proven capabilities of the da Vinci Xi, incorporating over 150 new enhancements. By the time of approval, da Vinci systems had already been used in over 410,000 procedures across Europe in 2024, contributing to nearly 17 million surgeries performed globally since their introduction.
“We are pleased that our da Vinci 5 Surgical System has received CE mark approval, marking its entry to Europe,” said Intuitive Chief Executive Officer Dave Rosa.
“At Intuitive, we’re focused on providing healthcare systems across Europe and around the world with thoughtful innovation that solves problems today and into the future. After over a decade of careful development, da Vinci 5 is the most advanced and integrated platform we’ve ever created, designed to enable better outcomes, efficiency, and insights for the future of minimally invasive care,” said Rosa.
The da Vinci 5 was developed to transform surgical care by offering enhanced sensory and operational capabilities. It introduced Force Feedback technology, a first for the platform, along with the most realistic 3D visualization system and an ergonomic console designed to improve the surgeon’s experience and extend career longevity.
To boost operational efficiency, the system incorporated tools that surgeons could manage directly, simplified the learning process with an intuitive design, and introduced a unified interface for care teams. Built-in dynamic assistance helped automate specific tasks, further improving surgical workflow.
Additionally, the system was powered by a highly intelligent platform that offered massively increased computing power, along with advanced sensors and processors. These innovations enabled the collection of detailed, actionable data, helping surgeons to better assess and continuously improve their surgical performance and patient care.
“We believe that the operational efficiencies and actionable insights provided by da Vinci 5 will not only help transform surgery but also help address critical challenges faced by healthcare systems across Europe,” said Dirk Barten, Intuitive’s senior vice president and general manager for Europe.
“It’s exciting that surgeons and care teams across Europe will have their choice of the full portfolio of da Vinci systems, including da Vinci 5, giving them greater choice and flexibility, and ultimately supporting quality care for more patients across the region,” said Barten.
As per DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On June 07, 2025, the U.S. FDA granted Boston Scientific Corporation (NYSE: BSX) approval to expand the use instructions for its FARAPULSE™ Pulsed Field Ablation (PFA) System. This updated approval allowed the system to be used for treating patients with drug-refractory, symptomatic persistent atrial fibrillation (AF), a chronic arrhythmia marked by abnormal heart rhythms lasting over seven days.
Persistent AF, which affects millions globally, often leads to symptoms like fatigue, dizziness, and breathlessness, while significantly raising stroke risk. The FARAPULSE PFA System has been used to treat AF by delivering precise pulses of energy through a catheter to ablate affected cardiac tissue. As part of the updated labeling, both the FARAWAVE™ and FARAWAVE NAV™ PFA Catheters were cleared for use in treating this more challenging form of AF.
“Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies,” said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”
The FDA’s approval for expanded labeling was supported by clinical data from phase one of the ADVANTAGE AF clinical trial, which had been presented at the AF Symposium 2025 and published in the Journal of the American College of Cardiology. The study met both primary safety and effectiveness endpoints. In this prospective, single-arm trial, 260 patients who had shown intolerance to at least one Class I or III anti-arrhythmic drug (AAD) were enrolled across 43 global sites. No incidents of stroke, pulmonary vein stenosis, atrio-esophageal fistula, or major access complications were reported. The rate of symptomatic AF recurrence-free survival stood at 85.3%. Observationally, among physicians who had conducted three or more procedures, this rate rose to 91.4%.
Boston Scientific had anticipated obtaining the CE mark, as well as regulatory approvals in Japan and China, in the months following the FDA approval. The company also launched the ReMATCH IDE clinical trial, enrolling approximately 375 patients across 40 centers in the U.S. and Asia. The trial was designed to assess the safety and effectiveness of the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AF who had previously undergone ablation using PFA, radiofrequency, or cryoablation technologies and experienced recurrence. The study also included evaluation of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus ablation and left atrial ablation of the mitral isthmus within the same patient population.
As per DelveInsight’s “Ablation Devices Market Report”, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2024 to 2030. Factors such as the increasing incidence of cancers, such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmia such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
On July 07, 2025, Trividia Health, Inc. announced that its TRUE METRIX® Self-Monitoring Blood Glucose Systems had been designated as preferred on all Managed Medicaid Plans and Fee-for-Service Medicaid in Pennsylvania, effective July 7, 2025. The TRUE METRIX® portfolio has delivered high performance rooted in scientific research and continuous technological advancements. Its test strips featured TRIPLE SENSE TECHNOLOGY®, ensuring clinical accuracy and confidence in blood glucose results.
The TRUE METRIX Test Strips were manufactured in the United States at the company’s facilities in Fort Lauderdale, Florida. Trividia Health had been recognized as the largest U.S. manufacturer of pharmacy-branded products for individuals with diabetes. For over 40 years, Trividia Health has remained committed to advancing diabetes care. The company had focused on developing innovative and affordable solutions to help millions of people manage their blood glucose levels effectively.
“Alongside our pharmacy and distribution partners, Trividia Health’s priority is providing accessibility through national coverage with a local presence. Having the TRUE METRIX Self-Monitoring Blood Glucose Meters and Test Strips as preferred products within Pennsylvania allows patients the ability to test with confidence and manage their diabetes,” said Jonathan Chapman, President and CEO of Trividia Health.
As per DelveInsight’s “Blood Glucose Monitoring Systems Market Report”, the blood glucose monitoring systems market was valued at USD 12.12 billion in 2024, growing at a CAGR of 7.72% during the forecast period from 2024 to 2030 to reach USD 18.89 billion by 2030. The blood glucose monitoring systems market is expanding rapidly due to the rising prevalence of lifestyle style disorders such as diabetes and impaired glucose tolerance, growing product launches and approvals by key players, and a rising preference for minimally invasive techniques that are expected to significantly drive the demand for blood glucose monitoring systems from 2024 to 2030.
On July 08, 2025, Cerapedics Inc., a global commercial-stage orthopedics company focused on redefining bone repair, announced the successful completion of the first patient treatment with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following its recent approval by the U.S. Food and Drug Administration (FDA). The PearlMatrix Bone Graft, a Class III drug-device combination product designed for lumbar fusion, was used in a post-approval procedure on an adult patient with degenerative disc disease (DDD). The surgery was performed by Dr. Sharad Rajpal, Medical Director of the Advanced Spine Program at AdventHealth Avista in Louisville, Colorado.
PearlMatrix Bone Graft had received FDA premarket approval in June 2025 and became the first and only bone growth accelerator shown to enhance lumbar fusion based on findings from the pivotal ASPIRE IDE study. Among more than 350 spinal bone grafts available in the U.S. market, Cerapedics had developed two of the only three that had successfully passed through the PMA (Premarket Approval) process.
“My goal is to bring my patients the most innovative and appropriate treatments specific to their needs, so they can regain their quality of life as soon as possible. I am proud to have performed the first post-approval procedure using PearlMatrix Bone Graft, a novel approach to treating degenerative disc disease,” said Sharad Rajpal, M.D., FAANS, FCNS, with AHMG. “It’s innovation like this that helps surgeons effectively treat patients, and it’s particularly gratifying to be able to use a Colorado innovation on a local resident.”
“This first surgery post-approval is a significant milestone for Cerapedics,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “Every single team member behind the development, approval, and distribution of PearlMatrix P-15 Peptide Enhanced Bone Graft worked tirelessly to get this unique drug-device into the hands of surgeons to help them safely and effectively treat their patients. We are proud of the innovation we bring to the market, and we look forward to seeing the positive impact of our devices.”
According to DelveInsight’s “Bone Graft and Substitute Market Report”, the bone graft and substitutes market was valued at USD 3,786.25 million in 2024, growing at a CAGR of 5.88% during the forecast period from 2025 to 2032 to reach USD 5,957.71 million by 2032. The increasing prevalence of bone-related disorders and trauma cases, coupled with a rising demand for bone grafts in dentistry, is significantly boosting the global market for bone grafts and substitutes. As bone diseases such as osteoporosis and bone fractures become more common, particularly among the aging population, the need for effective bone regeneration and repair solutions has surged. The growing geriatric population, which is more prone to bone degeneration, fractures, and joint issues, further drives demand for bone grafts, especially in orthopedic and dental procedures. Additionally, the increase in product development activities, with innovations in synthetic, allograft, and xenograft materials, is enhancing the effectiveness and availability of bone graft substitutes. These factors collectively contribute to the expansion of the bone graft and substitutes market, with more advanced, biocompatible, and cost-effective solutions being introduced to meet the rising demand during the forecast period from 2025 to 2032.
On July 7, 2025, Smith+Nephew, the global medical technology company, announced the release of its Q-FIX KNOTLESS All-Suture Anchor for soft tissue-to-bone fixation across multiple joint spaces, including the shoulder, hip, and foot & ankle. Building upon the established success of the Q-FIX Family, which had demonstrated best-in-class anchor fixation strength compared to competing devices, the Q-FIX KNOTLESS system raised the bar in all-suture anchor technology.
The device introduced proprietary features designed to deliver market-leading fixation strength, ultra-low displacement, and consistent deployment. It offered best-in-class soft tissue security through a secure suture lock mechanism, along with streamlined suture shuttling. The anchor also achieved market-leading biomechanical performance, including the lowest displacement during cyclic loading.
Additionally, the Q-FIX KNOTLESS system has provided surgeons with a range of suture options, including the single-loaded MINITAPE◊ Suture Tape, known for its low profile and even pressure distribution, and the ULTRABRAID◊ #2 Suture, which has proven to be 20% stronger than its nearest competitor.
“When I think of the Q-FIX family, I think of reliability,” commented Dr. Robert Litchfield, Orthopedic Surgeon, Sports Medicine Ontario, Canada. “We know that when we put a Q-FIX Anchor in, that we can count on it – the deployment is always predictable and the pullouts are impressive. In my experience, these anchors just don’t fail when we puta load on them.”
According to DelveInsight’s “Internal Trauma Fixation Devices Market Report”, the global internal trauma fixation devices market was valued at USD 9.52 billion in 2023, growing at a CAGR of 7.03% during the forecast period from 2024 to 2030 to reach USD 14.32 billion by 2030. The Internal Trauma Fixation Devices market is witnessing positive growth owing to the rising number of trauma and accident cases, increase in the prevalence of degenerative bone disorders, a growing number of sports-related injuries, technological innovation in product development, thereby contributing to the growth of the Internal Trauma Fixation Devices market during the forecast period from 2024 to 2030.
On July 08, 2025, Cochlear Limited, the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval of the Cochlear™ Nucleus® Nexa™ System, the world’s first and only smart cochlear implant system.
Previously, cochlear implant recipients could only access new technology through the external sound processor and typically needed a replacement processor to experience technological advancements. The newly launched Nexa System introduced upgradeable implant firmware, which, for the first time, allowed recipients to benefit from future innovations through both their implant and sound processor. This firmware update pathway was designed to improve sound processor upgrades and enhance the overall hearing experience, offering more flexible access to innovation over time.
Additionally, the Nucleus 8 Nexa Sound Processor with the Power Compact rechargeable battery was recognized as the smallest and lightest sound processor on the market with all-day battery life. A new implant-based algorithm, Dynamic Power Management, enabled the system to respond intuitively to users’ needs throughout the day while optimizing power efficiency. The processor was 9% smaller and 12% lighter than its predecessor, the Nucleus 8 with Power Extend, giving users the benefit of all-day hearing in a more compact, comfortable device.
“The Nucleus Nexa Implant is the first ever cochlear implant running its own firmware. Similar to smartphones, the implant firmware can be updated to enable new features and access future innovations. Recipients will now have access to their best possible hearing experience with both implant and sound processor updates. The Nucleus Nexa System builds upon Cochlear’s industry-leading portfolio of electrodes, which are designed to optimize the electrode-neural interface and protect cochlear health for a lifetime of hearing performance, and opens the door to even greater hearing potential for patients into the future. While it uses the same implant form factor as the most reliable cochlear implant in the industry, the new Nexa Implant features a totally new and redesigned chipset packed with innovative and smart features. This includes onboard diagnostics, which takes the pressure off carers and recipients by allowing the system to check itself and monitor to ensure it is performing to the best of the recipient’s hearing needs. This new system sets a new industry standard,” Jan Janssen, Chief Technology Officer at Cochlear, said.
The Nucleus Nexa Implant became the first cochlear implant with internal memory, enabling secure storage of personalized hearing settings (MAPs) within the implant itself. These settings could be easily transferred to any Nucleus Nexa Sound Processor in the future, helping recipients stay connected to sound even if their external processor was lost or damaged. The new system included the Nucleus Nexa Implant, the Nucleus Kanso 3 Nexa Sound Processor, and the Nucleus 8 Nexa Sound Processor. These devices were supported by an integrated ecosystem of tools designed to optimize patient outcomes, including Nucleus SmartNav, Nucleus Smart App, Custom Sound® Pro fitting software, and wireless accessories. Additionally, individuals with legacy Cochlear Nucleus Systems had been given the option to upgrade to the Kanso 3 Sound Processor. Both the Kanso 3 Nexa and Kanso 3 Sound Processors offered the full range of innovations introduced with the Nucleus 8, such as SmartSound iQ 2 with SCAN2† and automated ForwardFocus.As per DelveInsight’s “Cochlear Implants Market Report, the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is observing substantial market growth primarily owing to the increasing prevalence of hearing loss & incurs substantial economic costs, investing in cochlear implants & improving access to these devices and supportive reimbursement policies are anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
