Notizia - Recent Pharma, Healthcare and Biotech Happenings
Dec 18, 2025
Table of Contents
On December 15, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics portfolio in Europe after receiving In Vitro Diagnostic Medical Device Regulation (IVDR) certification for two VIASURE assays developed by Certest Biotec for use on the BD MAX™ System. This expansion strengthened the BD MAX™ system portfolio by enabling clinical laboratories to rapidly and accurately detect a wide range of pathogens using a fully automated molecular diagnostic platform.
The newly IVDR-certified assays included the VIASURE respiratory virus extended mix real-time PCR detection kit for the BD MAX™ system, designed to detect multiple respiratory viruses, including SARS-CoV-2, influenza A and B, RSV, parainfluenza, human coronaviruses, metapneumovirus, and adenovirus, from a single nasopharyngeal swab.
Click Here To Get the Article in PDF
Also included was the VIASURE HSV-1, HSV-2 & Treponema pallidum assay for the BD MAX™ system, which enabled identification of herpes simplex viruses (HSV-1 and HSV-2) and the bacterium responsible for syphilis (Treponema pallidum) using anogenital and oral skin lesion swabs.
The BD MAX™ system was capable of processing up to 24 samples per run and offered a broad assay menu covering healthcare-associated infections (HAI), respiratory, enteric, STI, and women’s health testing, along with open system functionality. Designed for use in clinical laboratories and hospitals, the system combined real-time PCR technology with automated nucleic acid extraction, amplification, and detection in a single integrated workflow. It delivered results in approximately three hours with minimal hands-on time per sample, supporting timely and accurate clinical decision-making and contributing to improved patient care.
“With these two assays, we are adding clinically relevant, targeted molecular panels to our already broad respiratory and STI menu,” said Philippe Villiard, vice president, BD Diagnostic Solutions in Europe. “Our partnership with Certest Biotec has been instrumental in expanding the BD MAX™ System menu and supports our commitment to delivering innovative diagnostic solutions that enable faster, more comprehensive detection of infectious diseases on the BD MAX™ System.”
“Our partnership with BD, which began in 2017, continues to grow and we are excited to strengthen our collaboration once again. We are confident that our joint efforts will result in exceptional projects in the future,” affirmed Certest’s CEO Nelson Fernandes.
As per DelveInsight’s “Molecular Diagnostics Market Report,” the molecular diagnostics market was valued at USD 9.56 billion in 2024, growing at a CAGR of 9.21% from 2025 to 2032, reaching USD 16.12 billion by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B and Hepatitis C, Influenza, and Human Papillomavirus (HPV). The introduction of new and innovative products by key molecular diagnostics companies, among others, is expected to drive the molecular diagnostics market from 2025 to 2032.
On December 16, 2025, OrthAlign, Inc., a global leader in surgical navigation technologies, announced the expansion of its Lantern® Hip platform to support posterior-based surgical approaches in total hip arthroplasty (THA). This update substantially broadened the platform’s clinical applicability, allowing surgeons to use Lantern hip for any THA procedure regardless of their preferred patient positioning, whether lateral or supine.
As most hip surgeons in the United States perform THA using posterior-based approaches, the software enhancement significantly increased access to Lantern’s handheld, imageless navigation technology. Lantern Hip was initially introduced in 2023 for procedures performed in the supine position, with full commercial availability for the lateral patient position planned for early 2026.
The Lantern Hip platform was developed to provide precise, real-time guidance to enable accurate implant placement and consistent leg-length restoration. For patients positioned laterally, surgeons could customize acetabular cup placement in the coronal plane based on individual anatomy, using live pelvic tracking to compensate for intraoperative pelvic movement. For patients in the supine position, the system enabled comparison of cup positioning across both the Anterior Pelvic Plane (APP) and Functional Pelvic Plane (FPP), as well as measurement of offset changes.
Lantern Hip was positioned as an accessible solution for hospitals and ambulatory surgery centers (ASCs). Its capital-free business model and portable design, combined with clinical accuracy and precision, made it a compelling alternative to large, fixed robotic systems. The platform’s instrumentation was compatible with most implant systems and surgical approaches, giving surgeons the flexibility to select the most appropriate implants and surgical plans without vendor limitations.
“The addition of posterior-based approaches to Lantern Hip is an important step forward in supporting surgeon choice without compromising accuracy. In my first case, the system provided the same intuitive workflow and confidence in implant positioning that Lantern is known for. Having a compact, reliable navigation tool that adapts to my preferred surgical approach and implant enhances both efficiency in the OR and consistency for my patients,” said Dr. McLaughlin.
“By accommodating posterior-based surgical approaches, OrthAlign now has the ability to support any surgeon performing total hip arthroplasty,” said Eric Timko, CEO of OrthAlign. “This expansion reflects our commitment to delivering high-value, user-friendly technologies that improve accuracy and accessibility for surgeons everywhere.”
According to DelveInsight’s “Hip Replacement Devices Market Report”, the hip reconstruction devices market was valued at USD 8.82 billion in 2023, growing at a CAGR of 5.04% during the forecast period from 2024 to 2030 to reach USD 11.83 billion by 2030. The hip reconstruction devices market is growing significantly due to the rising global incidence of osteoarthritis and osteoporosis, increasing numbers of hip fractures, coupled with advancements in joint-replacement technology and innovative product developments by leading hip reconstruction devices companies, is expected to escalate the demand for hip reconstruction devices during the forecast period from 2024 to 2030.
On December 14, 2025, Bioretec Oy, a pioneer in biodegradable orthopedic implants, received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its magnesium alloy–based, biodegradable RemeOs™ DrillPin.
The designation applied to the use of the RemeOs™ DrillPin for fixation of bone fragments in both pediatric and adult patients, as well as for the treatment of epi-metaphyseal fractures in pediatric patients aged two years and older with an open growth plate, including transphyseal indications where fixation across the growth plate was clinically required.
Breakthrough device designation was awarded to medical devices that demonstrated the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions and that represented breakthrough technologies or offered significant advantages over existing approved or cleared alternatives. The designation enabled Bioretec to engage in prioritized and more interactive communication with the FDA throughout the remaining development and review process, supporting a more efficient clinical and regulatory pathway for the DrillPin. The RemeOs™ DrillPin marked the third breakthrough device designation granted by the FDA to Bioretec for products within its RemeOs™ portfolio.
“Securing Breakthrough Device Designation for the RemeOs™ DrillPin is a major milestone for Bioretec and for patients. It confirms that there are no equivalent solutions addressing this unmet clinical need and recognizes the potential of our osteopromotive, magnesium based platform to change the way fractures are treated. Together with the CMS pass through status already granted for our RemeOs™ Trauma Screw, this designation strengthens our ability to build a commercially attractive and patient centric portfolio in the U.S. orthopedic market”, states Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.
As per DelveInsight’s “Orthopedic Implants Market Report,” the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2024 to 2030. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the increasing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period from 2024 to 2030.
On December 16, 2025, Medivis Inc., a pioneer in surgical intelligence, announced that it had received FDA 510(k) clearance for its cranial navigation platform, becoming the world’s first Augmented Reality (AR) system cleared for intraoperative guidance in cranial neurosurgery. This clearance represented Medivis’ second major FDA authorization of the year, following the launch of its spine navigation platform.
The Medivis platform used augmented reality to spatially align patient imaging within the operative field, providing surgeons with a clear, real-time visualization of critical anatomy and planned surgical trajectories. This capability enabled faster, more confident decision-making during cranial procedures, while minimizing workflow disruption and reducing reliance on external monitors. Its portable design enabled dependable image guidance in environments where conventional systems were limited, particularly in Intensive Care Units (ICUs), thereby extending image-guided precision to a broader range of clinical settings.
At the time, External Ventricular Drains (EVDs) were reported to be misplaced in up to 30% of cases, often resulting in repeated insertion attempts, patient harm, and delays in critical care. Early clinical experience indicated that Medivis’ real-time, AR-guided visualization at the bedside helped significantly reduce these misplacements, improving patient safety, accelerating life-saving interventions, and elevating the standard of care in neurosurgery.
Complex cases often involved overlapping diseases, rare clinical profiles, and conflicting research, making interpretation difficult. With more than 50% of U.S. adults reporting multiple chronic conditions (CDC, 2025), clinicians require tools that strengthen their expertise.
“For the first time, neurosurgeons can perform cranial procedures using augmented reality merging the digital and physical worlds with high-accuracy guidance,” said Dr. Osamah Choudhry, CEO and co-founder of Medivis. “This is a profound milestone not only for Medivis, but for the entire field of neurosurgery. With this clearance, we’re bringing image-guided navigation to the ICU, where it hasn’t been possible before, giving clinician’s greater precision at the bedside and helping support safer care for patients, while paving the way for full integration into operating rooms.”
“This achievement reflects an extraordinary collaboration between our team and the FDA, whose leadership and shared commitment to elevating patient care made this innovation possible,” said Dr. Christopher Morley, President and co-founder of Medivis. “This milestone not only attests to our technology’s capabilities but also lays the foundation for broad deployment of AR guidance across ICUs, operating rooms, and surgical centers worldwide advancing a future where surgical intelligence improves outcomes in every clinical setting.”
According to DelveInsight’s “Surgical Navigation Systems Market Report”, the global surgical navigation systems market was valued at USD 7,753.34 million in 2023, growing at a CAGR of 6.76% from 2024 to 2030. The demand for surgical navigation systems is primarily being boosted by the increasing prevalence of various chronic diseases such as stroke, Alzheimer’s, cerebrovascular disease, and others. Further, the rising incidence of orthopedic disorders, especially among the geriatric population, along with the increasing demand for minimally invasive surgical procedures and the growing research and development activities for surgical navigation systems, are thereby contributing to the overall growth of the surgical navigation systems market during the forecast period from 2024 to 2030.
On December 16, 2025, Cerapedics Inc., a global commercial-stage orthopedics company focused on advancing bone repair solutions, announced the publication of two consecutive papers in spine presenting the 24-month results from the ASPIRE pivotal Investigational Device Exemption (IDE) study of its PearlMatrix™ P-15 peptide-enhanced bone graft. The published findings showed that PearlMatrix achieved statistically superior clinical success and significantly faster time to fusion compared with local autograft in single-level Transforaminal Lumbar Interbody Fusion (TLIF) procedures in adult patients with degenerative disc disease (DDD).
ASPIRE was a prospective, single-blind, multicenter, randomized, controlled pivotal IDE study designed to assess the safety and effectiveness of PearlMatrix compared with local autograft bone graft in TLIF surgery. The study was carried out across 33 participating centers in the United States and enrolled 293 patients, including nearly 60 percent who were considered at high risk for non-union, such as individuals with type 2 diabetes, a body mass index of 30 or higher, and/or nicotine use.
At the 24-month follow-up, PearlMatrix met the primary endpoint of clinical composite success (CCS) and demonstrated statistical superiority over local autograft in CCS outcomes. The treatment was also associated with notably higher fusion rates at 24 months. No significant differences were observed between the treatment groups in terms of Oswestry Disability Index (ODI) improvement, neurological outcomes (motor and sensory), or the incidence of serious device-related adverse events.
“The publication of the ASPIRE study results in Spine underscores the strength of our clinical data for PearlMatrix as the first and only drug-device spinal bone graft product proven to accelerate lumbar fusion in patients with degenerative disc disease,” Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. “Cerapedics is dedicated to robust human clinical evidence to help surgeons provide safe and effective treatment options for their patients.”
“The ASPIRE study not only demonstrated higher fusion rates for PearlMatrix, as compared to local autograft in TLIF procedures, but it did so in a patient population reflective of typical higher risk patients,” said James S. Harrop, M.D., Professor, Neurological Surgery and Orthopedic Surgery, Division Chief, Spine and Peripheral Nerve Surgery, Thomas Jefferson University. “Unfortunately, in general, there is a lack of high-quality clinical data to support a majority of bone grafting products, especially for patients with comorbidities, which are known to have a significant impact on fusion and clinical success. This study adds literature to support a treatment option.”
According to DelveInsight’s “Spinal Fusion Devices Market Report,” the spinal fusion devices market was valued at USD 7,139.71 million in 2024, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032 to reach USD 10,762.88 million by 2032. The spinal fusion devices market is experiencing steady growth, driven by the rising instances of spinal disorders along with the growing global prevalence of chronic pain. Additionally, conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis are becoming increasingly common, particularly among the aging population. The surge in road traffic accidents further highlights the urgent need for effective spinal fusion solutions to restore mobility and reduce long-term disability. Additionally, the increase in product development activities among key market players is further driving the overall market for spinal fusion devices. Collectively, these factors are anticipated to fuel the expansion of the spinal fusion devices market over the forecast period from 2025 to 2032.
On December 16, 2025, Acumed, a global leader in innovative orthopedic and medical device solutions, announced that the first wrist fixation surgery using the Acu-Loc® NEXT System was successfully performed at Duke University Hospital in Durham, North Carolina. The procedure was completed by Dr. David Ruch, MD, Professor of Orthopaedic Surgery, and Dr. Marc Richard, MD, Professor of Orthopaedic Surgery.
The Acu-Loc NEXT System was developed by a team of leading surgeons to advance the treatment of wrist fractures. Building on Acumed’s 35-year history of innovation and the success of the original Acu-Loc System introduced in 2004, Acu-Loc NEXT was designed to address a broad range of fracture patterns. Over one million patients worldwide had previously regained motion, strength, and function with Acu-Loc implants.
The Acu-Loc NEXT System featured a redesigned screw platform with advanced functionality, simplified instrumentation, and clinically driven enhancements. These improvements enabled surgeons to deliver more personalized care across both complex and routine cases. The Acu-Loc NEXT wrist fixation system received FDA clearance in August 2025.
“The case was challenging,” said Dr. Richard. “The beauty of it was that the NEXT System preserved the things that I knew and trusted about the current system and allowed me to address some of the subtleties of the fracture with the nuanced instrumentation and tools and tricks for treating a very difficult distal radius fracture.”
“For over 20 plus years the Acu-Loc brand has set the standard in wrist fracture fixation in the healthcare community,” said Hjalmar Pompe van Meerdevoort, President of Acumed. “Acu-Loc NEXT is truly where the legacy of our ingenuity meets the innovation of our clinical partners and is what will continue to elevate that standard to meet our customers’ needs, allowing Acumed to be a true Partner of Choice.”
According to DelveInsight’s “Orthopedic Trauma Devices Market Report”, the global orthopedic trauma devices market is estimated to reach a size of USD 11,140.17 million in 2024 to USD 17,551.67 million by 2032, growing at a CAGR of 5.89% during the forecast period from 2025 to 2032. The rising cases of orthopedic injuries, growing prevalence of degenerative bone-related disorders, continuous technological advancements, and increasing product development activities by key players are collectively boosting the orthopedic trauma devices market. These factors are driving higher demand for advanced, effective, and innovative treatment solutions, leading to improved patient outcomes and broader adoption of trauma devices globally.
Article in PDF
Dec 18, 2025
Table of Contents
On December 15, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics portfolio in Europe after receiving In Vitro Diagnostic Medical Device Regulation (IVDR) certification for two VIASURE assays developed by Certest Biotec for use on the BD MAX™ System. This expansion strengthened the BD MAX™ system portfolio by enabling clinical laboratories to rapidly and accurately detect a wide range of pathogens using a fully automated molecular diagnostic platform.
The newly IVDR-certified assays included the VIASURE respiratory virus extended mix real-time PCR detection kit for the BD MAX™ system, designed to detect multiple respiratory viruses, including SARS-CoV-2, influenza A and B, RSV, parainfluenza, human coronaviruses, metapneumovirus, and adenovirus, from a single nasopharyngeal swab.
Also included was the VIASURE HSV-1, HSV-2 & Treponema pallidum assay for the BD MAX™ system, which enabled identification of herpes simplex viruses (HSV-1 and HSV-2) and the bacterium responsible for syphilis (Treponema pallidum) using anogenital and oral skin lesion swabs.
The BD MAX™ system was capable of processing up to 24 samples per run and offered a broad assay menu covering healthcare-associated infections (HAI), respiratory, enteric, STI, and women’s health testing, along with open system functionality. Designed for use in clinical laboratories and hospitals, the system combined real-time PCR technology with automated nucleic acid extraction, amplification, and detection in a single integrated workflow. It delivered results in approximately three hours with minimal hands-on time per sample, supporting timely and accurate clinical decision-making and contributing to improved patient care.
“With these two assays, we are adding clinically relevant, targeted molecular panels to our already broad respiratory and STI menu,” said Philippe Villiard, vice president, BD Diagnostic Solutions in Europe. “Our partnership with Certest Biotec has been instrumental in expanding the BD MAX™ System menu and supports our commitment to delivering innovative diagnostic solutions that enable faster, more comprehensive detection of infectious diseases on the BD MAX™ System.”
“Our partnership with BD, which began in 2017, continues to grow and we are excited to strengthen our collaboration once again. We are confident that our joint efforts will result in exceptional projects in the future,” affirmed Certest’s CEO Nelson Fernandes.
As per DelveInsight’s “Molecular Diagnostics Market Report,” the molecular diagnostics market was valued at USD 9.56 billion in 2024, growing at a CAGR of 9.21% from 2025 to 2032, reaching USD 16.12 billion by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B and Hepatitis C, Influenza, and Human Papillomavirus (HPV). The introduction of new and innovative products by key molecular diagnostics companies, among others, is expected to drive the molecular diagnostics market from 2025 to 2032.
On December 16, 2025, OrthAlign, Inc., a global leader in surgical navigation technologies, announced the expansion of its Lantern® Hip platform to support posterior-based surgical approaches in total hip arthroplasty (THA). This update substantially broadened the platform’s clinical applicability, allowing surgeons to use Lantern hip for any THA procedure regardless of their preferred patient positioning, whether lateral or supine.
As most hip surgeons in the United States perform THA using posterior-based approaches, the software enhancement significantly increased access to Lantern’s handheld, imageless navigation technology. Lantern Hip was initially introduced in 2023 for procedures performed in the supine position, with full commercial availability for the lateral patient position planned for early 2026.
The Lantern Hip platform was developed to provide precise, real-time guidance to enable accurate implant placement and consistent leg-length restoration. For patients positioned laterally, surgeons could customize acetabular cup placement in the coronal plane based on individual anatomy, using live pelvic tracking to compensate for intraoperative pelvic movement. For patients in the supine position, the system enabled comparison of cup positioning across both the Anterior Pelvic Plane (APP) and Functional Pelvic Plane (FPP), as well as measurement of offset changes.
Lantern Hip was positioned as an accessible solution for hospitals and ambulatory surgery centers (ASCs). Its capital-free business model and portable design, combined with clinical accuracy and precision, made it a compelling alternative to large, fixed robotic systems. The platform’s instrumentation was compatible with most implant systems and surgical approaches, giving surgeons the flexibility to select the most appropriate implants and surgical plans without vendor limitations.
“The addition of posterior-based approaches to Lantern Hip is an important step forward in supporting surgeon choice without compromising accuracy. In my first case, the system provided the same intuitive workflow and confidence in implant positioning that Lantern is known for. Having a compact, reliable navigation tool that adapts to my preferred surgical approach and implant enhances both efficiency in the OR and consistency for my patients,” said Dr. McLaughlin.
“By accommodating posterior-based surgical approaches, OrthAlign now has the ability to support any surgeon performing total hip arthroplasty,” said Eric Timko, CEO of OrthAlign. “This expansion reflects our commitment to delivering high-value, user-friendly technologies that improve accuracy and accessibility for surgeons everywhere.”
According to DelveInsight’s “Hip Replacement Devices Market Report”, the hip reconstruction devices market was valued at USD 8.82 billion in 2023, growing at a CAGR of 5.04% during the forecast period from 2024 to 2030 to reach USD 11.83 billion by 2030. The hip reconstruction devices market is growing significantly due to the rising global incidence of osteoarthritis and osteoporosis, increasing numbers of hip fractures, coupled with advancements in joint-replacement technology and innovative product developments by leading hip reconstruction devices companies, is expected to escalate the demand for hip reconstruction devices during the forecast period from 2024 to 2030.
On December 14, 2025, Bioretec Oy, a pioneer in biodegradable orthopedic implants, received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its magnesium alloy–based, biodegradable RemeOs™ DrillPin.
The designation applied to the use of the RemeOs™ DrillPin for fixation of bone fragments in both pediatric and adult patients, as well as for the treatment of epi-metaphyseal fractures in pediatric patients aged two years and older with an open growth plate, including transphyseal indications where fixation across the growth plate was clinically required.
Breakthrough device designation was awarded to medical devices that demonstrated the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions and that represented breakthrough technologies or offered significant advantages over existing approved or cleared alternatives. The designation enabled Bioretec to engage in prioritized and more interactive communication with the FDA throughout the remaining development and review process, supporting a more efficient clinical and regulatory pathway for the DrillPin. The RemeOs™ DrillPin marked the third breakthrough device designation granted by the FDA to Bioretec for products within its RemeOs™ portfolio.
“Securing Breakthrough Device Designation for the RemeOs™ DrillPin is a major milestone for Bioretec and for patients. It confirms that there are no equivalent solutions addressing this unmet clinical need and recognizes the potential of our osteopromotive, magnesium based platform to change the way fractures are treated. Together with the CMS pass through status already granted for our RemeOs™ Trauma Screw, this designation strengthens our ability to build a commercially attractive and patient centric portfolio in the U.S. orthopedic market”, states Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.
As per DelveInsight’s “Orthopedic Implants Market Report,” the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2024 to 2030. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the increasing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period from 2024 to 2030.
On December 16, 2025, Medivis Inc., a pioneer in surgical intelligence, announced that it had received FDA 510(k) clearance for its cranial navigation platform, becoming the world’s first Augmented Reality (AR) system cleared for intraoperative guidance in cranial neurosurgery. This clearance represented Medivis’ second major FDA authorization of the year, following the launch of its spine navigation platform.
The Medivis platform used augmented reality to spatially align patient imaging within the operative field, providing surgeons with a clear, real-time visualization of critical anatomy and planned surgical trajectories. This capability enabled faster, more confident decision-making during cranial procedures, while minimizing workflow disruption and reducing reliance on external monitors. Its portable design enabled dependable image guidance in environments where conventional systems were limited, particularly in Intensive Care Units (ICUs), thereby extending image-guided precision to a broader range of clinical settings.
At the time, External Ventricular Drains (EVDs) were reported to be misplaced in up to 30% of cases, often resulting in repeated insertion attempts, patient harm, and delays in critical care. Early clinical experience indicated that Medivis’ real-time, AR-guided visualization at the bedside helped significantly reduce these misplacements, improving patient safety, accelerating life-saving interventions, and elevating the standard of care in neurosurgery.
Complex cases often involved overlapping diseases, rare clinical profiles, and conflicting research, making interpretation difficult. With more than 50% of U.S. adults reporting multiple chronic conditions (CDC, 2025), clinicians require tools that strengthen their expertise.
“For the first time, neurosurgeons can perform cranial procedures using augmented reality merging the digital and physical worlds with high-accuracy guidance,” said Dr. Osamah Choudhry, CEO and co-founder of Medivis. “This is a profound milestone not only for Medivis, but for the entire field of neurosurgery. With this clearance, we’re bringing image-guided navigation to the ICU, where it hasn’t been possible before, giving clinician’s greater precision at the bedside and helping support safer care for patients, while paving the way for full integration into operating rooms.”
“This achievement reflects an extraordinary collaboration between our team and the FDA, whose leadership and shared commitment to elevating patient care made this innovation possible,” said Dr. Christopher Morley, President and co-founder of Medivis. “This milestone not only attests to our technology’s capabilities but also lays the foundation for broad deployment of AR guidance across ICUs, operating rooms, and surgical centers worldwide advancing a future where surgical intelligence improves outcomes in every clinical setting.”
According to DelveInsight’s “Surgical Navigation Systems Market Report”, the global surgical navigation systems market was valued at USD 7,753.34 million in 2023, growing at a CAGR of 6.76% from 2024 to 2030. The demand for surgical navigation systems is primarily being boosted by the increasing prevalence of various chronic diseases such as stroke, Alzheimer’s, cerebrovascular disease, and others. Further, the rising incidence of orthopedic disorders, especially among the geriatric population, along with the increasing demand for minimally invasive surgical procedures and the growing research and development activities for surgical navigation systems, are thereby contributing to the overall growth of the surgical navigation systems market during the forecast period from 2024 to 2030.
On December 16, 2025, Cerapedics Inc., a global commercial-stage orthopedics company focused on advancing bone repair solutions, announced the publication of two consecutive papers in spine presenting the 24-month results from the ASPIRE pivotal Investigational Device Exemption (IDE) study of its PearlMatrix™ P-15 peptide-enhanced bone graft. The published findings showed that PearlMatrix achieved statistically superior clinical success and significantly faster time to fusion compared with local autograft in single-level Transforaminal Lumbar Interbody Fusion (TLIF) procedures in adult patients with degenerative disc disease (DDD).
ASPIRE was a prospective, single-blind, multicenter, randomized, controlled pivotal IDE study designed to assess the safety and effectiveness of PearlMatrix compared with local autograft bone graft in TLIF surgery. The study was carried out across 33 participating centers in the United States and enrolled 293 patients, including nearly 60 percent who were considered at high risk for non-union, such as individuals with type 2 diabetes, a body mass index of 30 or higher, and/or nicotine use.
At the 24-month follow-up, PearlMatrix met the primary endpoint of clinical composite success (CCS) and demonstrated statistical superiority over local autograft in CCS outcomes. The treatment was also associated with notably higher fusion rates at 24 months. No significant differences were observed between the treatment groups in terms of Oswestry Disability Index (ODI) improvement, neurological outcomes (motor and sensory), or the incidence of serious device-related adverse events.
“The publication of the ASPIRE study results in Spine underscores the strength of our clinical data for PearlMatrix as the first and only drug-device spinal bone graft product proven to accelerate lumbar fusion in patients with degenerative disc disease,” Valeska Schroeder, PhD, Chief Executive Officer of Cerapedics. “Cerapedics is dedicated to robust human clinical evidence to help surgeons provide safe and effective treatment options for their patients.”
“The ASPIRE study not only demonstrated higher fusion rates for PearlMatrix, as compared to local autograft in TLIF procedures, but it did so in a patient population reflective of typical higher risk patients,” said James S. Harrop, M.D., Professor, Neurological Surgery and Orthopedic Surgery, Division Chief, Spine and Peripheral Nerve Surgery, Thomas Jefferson University. “Unfortunately, in general, there is a lack of high-quality clinical data to support a majority of bone grafting products, especially for patients with comorbidities, which are known to have a significant impact on fusion and clinical success. This study adds literature to support a treatment option.”
According to DelveInsight’s “Spinal Fusion Devices Market Report,” the spinal fusion devices market was valued at USD 7,139.71 million in 2024, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032 to reach USD 10,762.88 million by 2032. The spinal fusion devices market is experiencing steady growth, driven by the rising instances of spinal disorders along with the growing global prevalence of chronic pain. Additionally, conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis are becoming increasingly common, particularly among the aging population. The surge in road traffic accidents further highlights the urgent need for effective spinal fusion solutions to restore mobility and reduce long-term disability. Additionally, the increase in product development activities among key market players is further driving the overall market for spinal fusion devices. Collectively, these factors are anticipated to fuel the expansion of the spinal fusion devices market over the forecast period from 2025 to 2032.
On December 16, 2025, Acumed, a global leader in innovative orthopedic and medical device solutions, announced that the first wrist fixation surgery using the Acu-Loc® NEXT System was successfully performed at Duke University Hospital in Durham, North Carolina. The procedure was completed by Dr. David Ruch, MD, Professor of Orthopaedic Surgery, and Dr. Marc Richard, MD, Professor of Orthopaedic Surgery.
The Acu-Loc NEXT System was developed by a team of leading surgeons to advance the treatment of wrist fractures. Building on Acumed’s 35-year history of innovation and the success of the original Acu-Loc System introduced in 2004, Acu-Loc NEXT was designed to address a broad range of fracture patterns. Over one million patients worldwide had previously regained motion, strength, and function with Acu-Loc implants.
The Acu-Loc NEXT System featured a redesigned screw platform with advanced functionality, simplified instrumentation, and clinically driven enhancements. These improvements enabled surgeons to deliver more personalized care across both complex and routine cases. The Acu-Loc NEXT wrist fixation system received FDA clearance in August 2025.
“The case was challenging,” said Dr. Richard. “The beauty of it was that the NEXT System preserved the things that I knew and trusted about the current system and allowed me to address some of the subtleties of the fracture with the nuanced instrumentation and tools and tricks for treating a very difficult distal radius fracture.”
“For over 20 plus years the Acu-Loc brand has set the standard in wrist fracture fixation in the healthcare community,” said Hjalmar Pompe van Meerdevoort, President of Acumed. “Acu-Loc NEXT is truly where the legacy of our ingenuity meets the innovation of our clinical partners and is what will continue to elevate that standard to meet our customers’ needs, allowing Acumed to be a true Partner of Choice.”
According to DelveInsight’s “Orthopedic Trauma Devices Market Report”, the global orthopedic trauma devices market is estimated to reach a size of USD 11,140.17 million in 2024 to USD 17,551.67 million by 2032, growing at a CAGR of 5.89% during the forecast period from 2025 to 2032. The rising cases of orthopedic injuries, growing prevalence of degenerative bone-related disorders, continuous technological advancements, and increasing product development activities by key players are collectively boosting the orthopedic trauma devices market. These factors are driving higher demand for advanced, effective, and innovative treatment solutions, leading to improved patient outcomes and broader adoption of trauma devices globally.
