Notizia - Recent Pharma, Healthcare and Biotech Happenings
Dec 02, 2025
Dec 04, 2025
Table of Contents
On December 03, 2025, Medtronic (NYSE: MDT), a global leader in surgical innovation, announced that the U.S. Food and Drug Administration had granted clearance for the Hugo™ robotic-assisted surgery (RAS) system for use in urologic procedures, marking a significant milestone in expanding access to minimally invasive surgical care. With the U.S. long recognized as the global leader in robotic surgery adoption but still facing gaps in capacity and accessibility, the introduction of the Hugo RAS system had provided hospitals and surgeons with a versatile new platform to strengthen soft-tissue robotic surgery programs. Designed with extensive input from surgeons and hospital administrators, the system had been engineered to reshape the future of robotic-assisted surgery through three defining features.
Its modular architecture allowed the robotic arms to be moved and shared across different care settings, enabling better utilization and giving surgeons the flexibility to optimize anatomical access for each patient, while the open console improved situational awareness, reduced physical strain, and enhanced team training and communication. The system also integrated seamlessly into the Touch Surgery™ digital ecosystem, offering pre-operative simulation tools, remote tele-proctoring, and AI-driven post-operative insights that allowed surgeons to review procedure videos and refine techniques almost immediately after surgery. Moreover, Medtronic’s unique position as the only company capable of supporting open, laparoscopic, and robotic-assisted modalities strengthened its differentiated partnership model, giving surgical teams access to world-class training, comprehensive clinical and technical support, and the ability to work within a unified ecosystem of trusted Medtronic technologies and instruments.
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As per DelveInsight’s “Surgical Robotic System Market Insights, Competitive Landscape, and Market Forecast – 2032,” 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 December 01, 2025, Cleveland Diagnostics, Inc., a commercial-stage precision oncology company, announced that the U.S. Food and Drug Administration had granted Premarket Approval (PMA) for its IsoPSA® in vitro diagnostic (IVD) kit. The blood-based IsoPSA test had been approved as an aid for determining the need for prostate biopsy in men aged 50 and older with elevated PSA levels.
The FDA’s decision had been supported by evidence from a large, prospective clinical study carried out at 14 sites across the United States, along with extensive analytical validation data. Prostate cancer, the second most common cancer among American men, leads to more than a million prostate biopsies annually, even though up to 75% of these procedures ultimately yield negative results for high-grade disease. This long-standing diagnostic gap had contributed to unnecessary invasive procedures, emotional strain, and high healthcare costs. IsoPSA had helped address this issue by providing clinicians and patients with a more accurate assessment of a man’s risk for clinically significant prostate cancer, thereby improving confidence in biopsy decision-making. The IsoPSA IVD kit had been built on Cleveland Diagnostics’ IsoClear™ platform, a proprietary technology that analyzes protein biomarkers based on structural changes in the blood to deliver deeper, clinically meaningful insights into disease presence and severity.
“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” shared Arnon Chait, PhD, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
As per DelveInsight’s “In Vitro Diagnostics Market Insights, Competitive Landscape, and Market Forecast – 2030,” global in vitro diagnostics market was valued at USD 71.01 billion in 2024, growing at a CAGR of 4.71% during the forecast period from 2025 to 2032, in order to reach USD 93.60 billion by 2032. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as rising prevalence of various infectious diseases such as COVID-19, growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others.
On December 03, 2025, Innovative Medical Equipment, LLC (IME), the maker of ThermaZone®, announced that it had introduced its new Full Headcap at the American Headache Society’s 2025 Scottsdale Headache Symposium in Scottsdale, Arizona. The Full Headcap had expanded ThermaZone’s portfolio of specialized head pads designed to help individuals living with migraines and other forms of head pain manage their symptoms more effectively.
Because migraine relief often varies greatly from person to person depending on whether the pain is localized or diffuse and whether heat or cold provides better comfort the new Full Headcap had been created to address these differences. It incorporated IME’s proprietary Motion Advantage™ water-flow technology, which delivered precisely controlled thermal therapy to key areas of the head, including the forehead, temples, occipital region, and cranial surface. ThermaZone had also been engineered for continuous operation and offered five programmable timer modes 10, 20, or 30 minutes on/off, 30 minutes on/30 minutes off, and 30 minutes on/60 minutes off allowing both patients and clinicians to customize therapy safely and effectively.
“Many migraine sufferers rely on gel caps that must be frozen or heated before use,” said Brad Pulver, President of IME. “These products quickly lose temperature, often within 20 minutes, and do not provide sustained relief. ThermaZone offers ten heating and ten cooling levels that maintain consistent temperatures for as long as needed, giving users the personalized therapy they deserve.”
According to DelveInsight’s “Migraine Market Insights, Competitive Landscape, and Market Forecast-2030,” The Migraine market report provides current treatment methods, emerging medical devices, market share based on treatment type, device placement and end-user, current and forecasted Migraine symptoms market size from 2018 to 2030 segmented by seven major markets. The report also covers current Migraine symptoms, medical devices used in treatment, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
On December 3, 2025, Astrin Biosciences, a cancer intelligence company focused on transforming cancer detection and treatment through deep proteomics and AI, announced that it had launched Certitude™, a first-of-its-kind, non-imaging, blood-based test for early cancer detection. Findings from the company’s latest study were scheduled to be presented at the San Antonio Breast Cancer Symposium (SABCS), held from December 10–14, 2025.
The study, titled “Deep Proteomics and AI Classifier for Early Breast Cancer Detection,” was set to be highlighted on December 11, and Astrin had planned to showcase Certitude at booth #1328 during the conference.
In a clinical evaluation involving 1,242 women, Certitude had demonstrated 92% sensitivity and 93% specificity across various breast cancer stages and subtypes. With a negative predictive value exceeding 99.9%, the test was expected to significantly decrease unnecessary imaging and biopsies that often contribute to overtreatment. Although mammography had long facilitated early-stage breast cancer detection in many patients, nearly half of women have dense breast tissue, which limits the accuracy of current imaging methods. Astrin’s results had shown that deep proteomic profiling could provide a powerful supplement to mammography by detecting cancer-associated protein signatures in women with dense breast tissue much earlier than what could be identified through imaging or circulating tumor DNA.
According to DelveInsight’s “Global Blood Cancer Diagnostics Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global blood cancer diagnostics market is estimated to grow at a CAGR of 6.34% during the forecast period from 2024 to 2030. The blood cancer diagnostics market is slated to witness prosperity owing to factors such as growing prevalence blood cancer worldwide, increasing geriatric population, rising number of risk factors associated with blood cancer, and the growing focus on improving the safety, and usability of blood cancer diagnostics for end users are further expected to result in the appreciable revenue growth in the blood cancer diagnostics market during the forecast period 2024 to 2030.
On December 2, 2025, SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, had announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA approved a reduction in the required enrollment size for the SAVE Surveillance Registry from the initially mandated 300 patients to just 50. This smaller registry size fulfilled the post-approval surveillance requirement under the original Humanitarian Device Exemption (HDE), reflecting the FDA’s confidence that continued device safety could be demonstrated with fewer patients than originally specified.
The SAVE Surveillance Registry, a Post-Approval Study (PAS), was designed to reaffirm the safety of QUELIMMUNE therapy, which received approval in 2024 for treating children with acute kidney injury (AKI) and sepsis or septic conditions. By that time, data from 32 pediatric patients had been included in the registry. Earlier findings from the registry were presented at the 5th International Symposium on Acute Kidney Injury in Children, emphasizing the role of QUELIMMUNE (Selective Cytopheretic Device for Pediatrics, SCD-PED) in managing critically ill pediatric patients with life-threatening AKI and sepsis who required Renal Replacement Therapy (RRT).
Results from the first 21 pediatric patients showed no device-related adverse events or infections and no evidence of immunosuppressive effects. Survival rates were reported at 76% for Day 28 and Day 60, and 71% for Day 90. These findings supported projections of a 50% reduction in mortality compared to historical outcomes published in Kidney Medicine. QUELIMMUNE therapy had already been adopted by several top-rated children’s hospitals in the United States, and the underlying Selective Cytopheretic Device (SCD) technology demonstrated broad potential for treating severe hyperinflammation responsible for organ failure and mortality.
“The SAVE Surveillance Registry has provided valuable clinical outcomes data on both the safety and efficacy of our QUELIMMUNE therapy, but it has also slowed the adoption process and potential to treat these pediatric patients due to the complexities of setting up and running a patient registry at these medical institutions,” stated Tim Varacek, Senior Vice President, Commercial and Business Operations. “There has been very strong interest in QUELIMMUNE adoption and we are pleased that we can satisfy FDA’s registry requirements with far fewer patients than expected, enabling a smoother adoption process and potentially expanding the revenue opportunity to capture a larger portion of the total pediatric AKI market which we estimate to be about $100 million in the U.S. alone.”
According to DelveInsight’s “Extracorporeal Circulation System Market Insights, Competitive Landscape, and Market Forecast-2030,” the global extracorporeal circulation systems market size was valued at approximately USD 3.5 billion in 2023 and is projected to reach around USD 5.8 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.2% during the forecast period. The market for extracorporeal circulation systems is being driven by several key factors, primarily the rising global burden of cardiovascular diseases that has increased the number of coronary artery bypass graft (CABG) surgeries and other open-heart procedures requiring heart–lung machines, oxygenators, and associated perfusion technologies. Growing adoption of advanced cardiac surgeries especially in aging populations continues to push hospitals to invest in reliable extracorporeal support systems that ensure adequate organ perfusion during complex procedures. Technological advancements, such as integrated monitoring capabilities, improved biocompatible materials, and compact extracorporeal circulation platforms, are further enhancing clinical outcomes and boosting demand. Additionally, expanding healthcare infrastructure in emerging markets, along with greater access to cardiac surgical care, is increasing the use of extracorporeal circulation devices. Increasing awareness of perioperative safety, rising volumes of pediatric and adult cardiac surgeries, and product innovations by leading manufacturers collectively contribute to the strong growth trajectory of the extracorporeal circulation system market.
On December 3, 2025, MiRus announced that patients covered by the Centers for Medicare and Medicaid Services (CMS) had become beneficiaries of its latest technology, the EUROPA® Posterior Cervical (PCF) System, developed with the company’s proprietary rhenium alloys for treating cervical and upper thoracic spinal conditions. The EUROPA® PCF system had already secured a New Technology Add-on Payment (NTAP) from CMS earlier in the year.
Amid rising healthcare costs and tighter hospital budgets, many institutions had faced challenges in delivering optimal care to vulnerable patients requiring complex, lifesaving posterior cervical surgeries. The EUROPA® PCF system had previously received FDA Breakthrough Device Designation, signifying that it represented a meaningful technological advancement capable of supporting a broader patient population. Surgeons, who had long struggled with issues such as hardware prominence, skipped levels, limited biologics, quad-rod configurations, and other compromises in posterior cervical procedures, now had access to a device designed to address these longstanding limitations.
“We are pleased that CMS has recognized the EUROPA® PCF System as a better option for treating the complex clinical cervical and upper thoracic spine procedures by awarding the NTAP designation. CxOs of hospitals tell us that they want broader adoption of this new technology because they can treat more CMS patients, and avail of the CMS incentives to help hospitals offset cost pressures,” commented Mahesh Krishnan, Chief Commercial Officer.According to DelveInsight’s “Spinal Implants Market Insights, Competitive Landscape, and Market Forecast – 2032”, the global spinal implants market was valued at USD 14,324.12 million in 2024, growing at a CAGR of 5.50% during the forecast period from 2025 to 2032 to reach USD 21,899.24 million by 2032. The rising cases of spinal disorders particularly among aging populations have significantly increased the demand for corrective surgical interventions. Simultaneously, the surge in sports-related and accident-induced spinal injuries is fueling the need for advanced implantable solutions. Moreover, there is a growing preference for non-fusion and motion preservation devices that maintain spinal mobility and enhance patient outcomes, especially among younger and more active individuals. Coupled with this is the uptick in product development activities and technological innovations by key market players globally, which is expanding the range of available solutions and improving surgical success rates. Together, these trends are accelerating the adoption of spinal implants and driving the overall market during the forecast period from 2025 to 2032.
Article in PDF
Dec 02, 2025
Nov 28, 2025
Table of Contents
On December 03, 2025, Medtronic (NYSE: MDT), a global leader in surgical innovation, announced that the U.S. Food and Drug Administration had granted clearance for the Hugo™ robotic-assisted surgery (RAS) system for use in urologic procedures, marking a significant milestone in expanding access to minimally invasive surgical care. With the U.S. long recognized as the global leader in robotic surgery adoption but still facing gaps in capacity and accessibility, the introduction of the Hugo RAS system had provided hospitals and surgeons with a versatile new platform to strengthen soft-tissue robotic surgery programs. Designed with extensive input from surgeons and hospital administrators, the system had been engineered to reshape the future of robotic-assisted surgery through three defining features.
Its modular architecture allowed the robotic arms to be moved and shared across different care settings, enabling better utilization and giving surgeons the flexibility to optimize anatomical access for each patient, while the open console improved situational awareness, reduced physical strain, and enhanced team training and communication. The system also integrated seamlessly into the Touch Surgery™ digital ecosystem, offering pre-operative simulation tools, remote tele-proctoring, and AI-driven post-operative insights that allowed surgeons to review procedure videos and refine techniques almost immediately after surgery. Moreover, Medtronic’s unique position as the only company capable of supporting open, laparoscopic, and robotic-assisted modalities strengthened its differentiated partnership model, giving surgical teams access to world-class training, comprehensive clinical and technical support, and the ability to work within a unified ecosystem of trusted Medtronic technologies and instruments.
As per DelveInsight’s “Surgical Robotic System Market Insights, Competitive Landscape, and Market Forecast – 2032,” 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 December 01, 2025, Cleveland Diagnostics, Inc., a commercial-stage precision oncology company, announced that the U.S. Food and Drug Administration had granted Premarket Approval (PMA) for its IsoPSA® in vitro diagnostic (IVD) kit. The blood-based IsoPSA test had been approved as an aid for determining the need for prostate biopsy in men aged 50 and older with elevated PSA levels.
The FDA’s decision had been supported by evidence from a large, prospective clinical study carried out at 14 sites across the United States, along with extensive analytical validation data. Prostate cancer, the second most common cancer among American men, leads to more than a million prostate biopsies annually, even though up to 75% of these procedures ultimately yield negative results for high-grade disease. This long-standing diagnostic gap had contributed to unnecessary invasive procedures, emotional strain, and high healthcare costs. IsoPSA had helped address this issue by providing clinicians and patients with a more accurate assessment of a man’s risk for clinically significant prostate cancer, thereby improving confidence in biopsy decision-making. The IsoPSA IVD kit had been built on Cleveland Diagnostics’ IsoClear™ platform, a proprietary technology that analyzes protein biomarkers based on structural changes in the blood to deliver deeper, clinically meaningful insights into disease presence and severity.
“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” shared Arnon Chait, PhD, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
As per DelveInsight’s “In Vitro Diagnostics Market Insights, Competitive Landscape, and Market Forecast – 2030,” global in vitro diagnostics market was valued at USD 71.01 billion in 2024, growing at a CAGR of 4.71% during the forecast period from 2025 to 2032, in order to reach USD 93.60 billion by 2032. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as rising prevalence of various infectious diseases such as COVID-19, growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others.
On December 03, 2025, Innovative Medical Equipment, LLC (IME), the maker of ThermaZone®, announced that it had introduced its new Full Headcap at the American Headache Society’s 2025 Scottsdale Headache Symposium in Scottsdale, Arizona. The Full Headcap had expanded ThermaZone’s portfolio of specialized head pads designed to help individuals living with migraines and other forms of head pain manage their symptoms more effectively.
Because migraine relief often varies greatly from person to person depending on whether the pain is localized or diffuse and whether heat or cold provides better comfort the new Full Headcap had been created to address these differences. It incorporated IME’s proprietary Motion Advantage™ water-flow technology, which delivered precisely controlled thermal therapy to key areas of the head, including the forehead, temples, occipital region, and cranial surface. ThermaZone had also been engineered for continuous operation and offered five programmable timer modes 10, 20, or 30 minutes on/off, 30 minutes on/30 minutes off, and 30 minutes on/60 minutes off allowing both patients and clinicians to customize therapy safely and effectively.
“Many migraine sufferers rely on gel caps that must be frozen or heated before use,” said Brad Pulver, President of IME. “These products quickly lose temperature, often within 20 minutes, and do not provide sustained relief. ThermaZone offers ten heating and ten cooling levels that maintain consistent temperatures for as long as needed, giving users the personalized therapy they deserve.”
According to DelveInsight’s “Migraine Market Insights, Competitive Landscape, and Market Forecast-2030,” The Migraine market report provides current treatment methods, emerging medical devices, market share based on treatment type, device placement and end-user, current and forecasted Migraine symptoms market size from 2018 to 2030 segmented by seven major markets. The report also covers current Migraine symptoms, medical devices used in treatment, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
On December 3, 2025, Astrin Biosciences, a cancer intelligence company focused on transforming cancer detection and treatment through deep proteomics and AI, announced that it had launched Certitude™, a first-of-its-kind, non-imaging, blood-based test for early cancer detection. Findings from the company’s latest study were scheduled to be presented at the San Antonio Breast Cancer Symposium (SABCS), held from December 10–14, 2025.
The study, titled “Deep Proteomics and AI Classifier for Early Breast Cancer Detection,” was set to be highlighted on December 11, and Astrin had planned to showcase Certitude at booth #1328 during the conference.
In a clinical evaluation involving 1,242 women, Certitude had demonstrated 92% sensitivity and 93% specificity across various breast cancer stages and subtypes. With a negative predictive value exceeding 99.9%, the test was expected to significantly decrease unnecessary imaging and biopsies that often contribute to overtreatment. Although mammography had long facilitated early-stage breast cancer detection in many patients, nearly half of women have dense breast tissue, which limits the accuracy of current imaging methods. Astrin’s results had shown that deep proteomic profiling could provide a powerful supplement to mammography by detecting cancer-associated protein signatures in women with dense breast tissue much earlier than what could be identified through imaging or circulating tumor DNA.
According to DelveInsight’s “Global Blood Cancer Diagnostics Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global blood cancer diagnostics market is estimated to grow at a CAGR of 6.34% during the forecast period from 2024 to 2030. The blood cancer diagnostics market is slated to witness prosperity owing to factors such as growing prevalence blood cancer worldwide, increasing geriatric population, rising number of risk factors associated with blood cancer, and the growing focus on improving the safety, and usability of blood cancer diagnostics for end users are further expected to result in the appreciable revenue growth in the blood cancer diagnostics market during the forecast period 2024 to 2030.
On December 2, 2025, SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, had announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA approved a reduction in the required enrollment size for the SAVE Surveillance Registry from the initially mandated 300 patients to just 50. This smaller registry size fulfilled the post-approval surveillance requirement under the original Humanitarian Device Exemption (HDE), reflecting the FDA’s confidence that continued device safety could be demonstrated with fewer patients than originally specified.
The SAVE Surveillance Registry, a Post-Approval Study (PAS), was designed to reaffirm the safety of QUELIMMUNE therapy, which received approval in 2024 for treating children with acute kidney injury (AKI) and sepsis or septic conditions. By that time, data from 32 pediatric patients had been included in the registry. Earlier findings from the registry were presented at the 5th International Symposium on Acute Kidney Injury in Children, emphasizing the role of QUELIMMUNE (Selective Cytopheretic Device for Pediatrics, SCD-PED) in managing critically ill pediatric patients with life-threatening AKI and sepsis who required Renal Replacement Therapy (RRT).
Results from the first 21 pediatric patients showed no device-related adverse events or infections and no evidence of immunosuppressive effects. Survival rates were reported at 76% for Day 28 and Day 60, and 71% for Day 90. These findings supported projections of a 50% reduction in mortality compared to historical outcomes published in Kidney Medicine. QUELIMMUNE therapy had already been adopted by several top-rated children’s hospitals in the United States, and the underlying Selective Cytopheretic Device (SCD) technology demonstrated broad potential for treating severe hyperinflammation responsible for organ failure and mortality.
“The SAVE Surveillance Registry has provided valuable clinical outcomes data on both the safety and efficacy of our QUELIMMUNE therapy, but it has also slowed the adoption process and potential to treat these pediatric patients due to the complexities of setting up and running a patient registry at these medical institutions,” stated Tim Varacek, Senior Vice President, Commercial and Business Operations. “There has been very strong interest in QUELIMMUNE adoption and we are pleased that we can satisfy FDA’s registry requirements with far fewer patients than expected, enabling a smoother adoption process and potentially expanding the revenue opportunity to capture a larger portion of the total pediatric AKI market which we estimate to be about $100 million in the U.S. alone.”
According to DelveInsight’s “Extracorporeal Circulation System Market Insights, Competitive Landscape, and Market Forecast-2030,” the global extracorporeal circulation systems market size was valued at approximately USD 3.5 billion in 2023 and is projected to reach around USD 5.8 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.2% during the forecast period. The market for extracorporeal circulation systems is being driven by several key factors, primarily the rising global burden of cardiovascular diseases that has increased the number of coronary artery bypass graft (CABG) surgeries and other open-heart procedures requiring heart–lung machines, oxygenators, and associated perfusion technologies. Growing adoption of advanced cardiac surgeries especially in aging populations continues to push hospitals to invest in reliable extracorporeal support systems that ensure adequate organ perfusion during complex procedures. Technological advancements, such as integrated monitoring capabilities, improved biocompatible materials, and compact extracorporeal circulation platforms, are further enhancing clinical outcomes and boosting demand. Additionally, expanding healthcare infrastructure in emerging markets, along with greater access to cardiac surgical care, is increasing the use of extracorporeal circulation devices. Increasing awareness of perioperative safety, rising volumes of pediatric and adult cardiac surgeries, and product innovations by leading manufacturers collectively contribute to the strong growth trajectory of the extracorporeal circulation system market.
On December 3, 2025, MiRus announced that patients covered by the Centers for Medicare and Medicaid Services (CMS) had become beneficiaries of its latest technology, the EUROPA® Posterior Cervical (PCF) System, developed with the company’s proprietary rhenium alloys for treating cervical and upper thoracic spinal conditions. The EUROPA® PCF system had already secured a New Technology Add-on Payment (NTAP) from CMS earlier in the year.
Amid rising healthcare costs and tighter hospital budgets, many institutions had faced challenges in delivering optimal care to vulnerable patients requiring complex, lifesaving posterior cervical surgeries. The EUROPA® PCF system had previously received FDA Breakthrough Device Designation, signifying that it represented a meaningful technological advancement capable of supporting a broader patient population. Surgeons, who had long struggled with issues such as hardware prominence, skipped levels, limited biologics, quad-rod configurations, and other compromises in posterior cervical procedures, now had access to a device designed to address these longstanding limitations.
“We are pleased that CMS has recognized the EUROPA® PCF System as a better option for treating the complex clinical cervical and upper thoracic spine procedures by awarding the NTAP designation. CxOs of hospitals tell us that they want broader adoption of this new technology because they can treat more CMS patients, and avail of the CMS incentives to help hospitals offset cost pressures,” commented Mahesh Krishnan, Chief Commercial Officer.According to DelveInsight’s “Spinal Implants Market Insights, Competitive Landscape, and Market Forecast – 2032”, the global spinal implants market was valued at USD 14,324.12 million in 2024, growing at a CAGR of 5.50% during the forecast period from 2025 to 2032 to reach USD 21,899.24 million by 2032. The rising cases of spinal disorders particularly among aging populations have significantly increased the demand for corrective surgical interventions. Simultaneously, the surge in sports-related and accident-induced spinal injuries is fueling the need for advanced implantable solutions. Moreover, there is a growing preference for non-fusion and motion preservation devices that maintain spinal mobility and enhance patient outcomes, especially among younger and more active individuals. Coupled with this is the uptick in product development activities and technological innovations by key market players globally, which is expanding the range of available solutions and improving surgical success rates. Together, these trends are accelerating the adoption of spinal implants and driving the overall market during the forecast period from 2025 to 2032.
