Notizia - Recent Pharma, Healthcare and Biotech Happenings
Sep 18, 2025
Table of Contents
On September 17, 2025, Amber Implants, a pioneering medical technology company focused on developing advanced solutions for spinal injuries, announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its VCFix® Spinal System. This milestone validates the device’s safety and efficacy while serving as a globally recognized endorsement of its clinical value, enabling immediate entry into the world’s largest MedTech market.
The VCFix® Spinal System is an innovative vertebral augmentation platform designed to address a wide range of vertebral compression fractures treatment. Offering a minimally invasive approach, it works in conjunction with bone cement to deliver robust anterior and posterior column support. The system integrates smoothly into current surgical practices and has the potential to enhance spinal stabilization, lower patient risk, and reduce procedure times compared to existing treatments.
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Clinical data from a one-year follow-up of the initial trials, released in June 2025, highlighted sustained pain reduction, improved spinal stability, and accelerated recovery, emphasizing its long-term functional benefits. Looking ahead, Amber Implants is pursuing CE marking in the European Union, targeting broad indications that support both stand-alone use of VCFix® and its combination with posterior fixation systems.
Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, said, “The VCFix Spinal System is a groundbreaking vertebral augmentation solution with the potential to establish a new standard of care in vertebral fracture management, reinforcing Amber Implants’ role as a global innovator in spinal fracture solutions. The US, as the world’s largest MedTech market, provides an ideal platform for growth with a potential market in excess of €800m, and this clearance lays the foundation to initiate our commercial launch activities.”
Dr. Mohammad Ahmadi, Co-Founder and Chief Technology Officer of Amber Implants, added: “We will begin our US commercial launch with a pilot program in early 2026, accompanied by the expansion of the EXPAND pivotal trial into the US. This will be followed by broader physician availability from later in 2026. At the same time, we continue to pursue EU label expansion for stand-alone use and integration with one-level fixation.”
As per DelveInsight’s “Spinal Implants Market Report,” 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 spinal non-fusion devices 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.
On September 12, 2025, Merit Medical Systems, Inc., a global leader in healthcare technology, announced that its Embosphere® Microspheres have received approval in the European Union for use in genicular artery embolisation (GAE), a minimally invasive treatment for patients with knee osteoarthritis (OA).
Osteoarthritis is the most prevalent form of arthritis, affecting an estimated 595 million people worldwide, with the knee being the joint most commonly impacted. Factors such as an aging population, rising obesity rates, and sports or occupational injuries continue to drive this growing burden, and prevalence is expected to increase further.
An interventional radiologist performs GAE and works by selectively reducing blood flow to the inflamed synovium, the thin joint lining. This approach has been shown to provide substantial pain relief, enhanced mobility and function, and may help delay or even eliminate the need for surgery. As part of the expanding field of musculoskeletal embolisation, GAE reflects the broader trend toward minimally invasive, image-guided pain management therapies.
Clinical data demonstrate that over 75% of patients treated with Embosphere for GAE achieved sustained clinical success, with significant reductions in knee pain lasting up to 24 months. Patients also reported reduced dependence on pain medications and improvements in quality-of-life measures. Notably, compared to corticosteroid injections, GAE with Embosphere delivered consistently superior outcomes, with greater improvements in both pain and quality of life observed as early as three months.
Embosphere is engineered from a proprietary tris-acrylic cross-linked co-polymer and features a uniform spherical shape designed to achieve durable and complete occlusion of target blood vessels. With tighter calibration than other devices, it ensures predictable and reliable performance, a critical factor when treating the small genicular arteries.
Backed by over 25 years of clinical use, Embosphere is one of the most widely studied embolotherapy solutions, with evidence documented in more than 130 pivotal clinical publications and over 800,000 patients treated worldwide. It has demonstrated long-term effectiveness across a wide range of conditions, including uterine fibroids, arteriovenous malformations (AVM), and benign prostatic hyperplasia (BPH).
“This expanded indication underscores our commitment to continued innovation that supports the minimally invasive therapies our healthcare partners provide,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “In the case of Embosphere, a long-standing leader in the embolic space, it remains a trusted solution whose use has grown in ways that have positively impacted patient lives and will pave the way for embolotherapy well into the future.”
As per DelveInsight’s “Minimally Invasive Surgical Devices Market Report,” the global minimally invasive surgical devices market is expected to increase from USD 30,798.01 million in 2024 to USD 53,259.85 million by 2032, growing at a CAGR of 7.13% during the forecast period from 2025 to 2032. The demand for minimally invasive surgical devices is being primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular disorders, among others. Additionally, the global increase in the number of surgical procedures being performed using minimally invasive techniques, coupled with growing technological advancements and an increase in product development activities among the key market players, are key factors contributing to the positive growth of the minimally invasive surgical devices market during the forecast period from 2025 to 2032.
On September 16, 2025, in the expanding sector of non-invasive, energy-based aesthetic treatments, aesthetic laser skin resurfacing has continued to hold a dominant position due to its effectiveness in addressing fine lines, wrinkles, pigmentation issues, acne scars, and sun damage, while also improving overall skin texture and tone. In line with this growing demand, Rejuva Fresh® has further solidified its reputation as a leader in skin resurfacing technologies in North America with the launch of its REVIVO™ Dual Summit 1927/1550 Fractional Laser System.
The REVIVO™ system, introduced as an advanced skin resurfacing solution, combined fractional non-ablative Erbium (1550nm) and micro-ablative and non-ablative Thulium (1927nm) laser technologies. A standout feature of this device was the SPECTRAL MIX mode, which allowed both wavelengths to be used simultaneously, marking a significant improvement over previous technologies like Fraxel Dual, which only enabled the use of one wavelength at a time. This combination made the device particularly effective and customizable for a range of skin concerns and patient profiles.
The system was engineered to deliver fast treatments, minimal downtime, and highly visible results, catering to the needs of modern patients and aesthetic providers. It was also suitable for all Fitzpatrick skin types (I–VI), expanding its usability across diverse populations. Unique features included five specialized treatment heads, three laser output modes, four pulse shape options, and Rejuva Fresh’s proprietary PULSE SHAPE CONTROL technology, which collectively enhanced treatment precision and safety.
With 30 watts of laser power, a larger beam diameter, and an ergonomic roller handpiece, REVIVO™ provided uniform application and effective skin resurfacing in as little as 15–20 minutes. Its ability to deliver ablative, micro-ablative, and non-ablative treatments offered flexibility to providers, enabling them to tailor each session based on the severity of the condition and the patient’s comfort level. Cooling was recommended during treatment to enhance the patient experience.
Clinically, the system was used to treat a broad range of concerns, including wrinkles, sun damage, pigmentation disorders, acne scars, uneven skin tone, and even hair restoration. The 1550nm Erbium wavelength worked on deeper layers of the skin to stimulate collagen and repair dermal damage, while the 1927nm Thulium wavelength targeted the epidermis for pigment correction and texture refinement. In combination, they provided a synergistic effect, breaking down scar tissue, improving tone, and lifting indented acne scars.
In addition to facial resurfacing, REVIVO™ was also applied in scalp treatments for hair restoration, promoting neo-vascularization and enhancing results when used with topical serums. The device’s versatility and effectiveness made it a major advancement in energy-based aesthetic treatment technologies.
Huapei Cai, President and General Manager of Rejuva Fresh LLC Asia Pacific, emphasized: “The REVIVO™ exemplifies our unique collaborations with global manufacturers, integrating advanced engineering with Rejuva Fresh’s deep understanding of provider and patient needs. Our R&D team and clinical specialists worked closely to design effective treatment protocols, just as we did with EMShape® Neo Plus.”
Overall, the launch of the REVIVO™ Dual Summit system marked a significant technological leap in the laser aesthetics industry, offering providers a powerful tool to deliver faster, safer, and more customized skin treatments with minimal recovery time.
According to DelveInsight’s “Energy-based Aesthetic Devices (EAD) Market Report,” the energy-based aesthetic devices market was valued at USD 3.36 billion in 2023, growing at a CAGR of 8.93% during the forecast period from 2024 to 2030, to reach USD 5.60 billion by 2030. The energy-based aesthetic devices market is experiencing significant growth due to the increasing instances of surgical and non-surgical aesthetic procedures, rising efforts by key players to develop and launch new and innovative products, coupled with the preference for minimally invasive procedures, that are acting as major factors contributing to the overall growth of the energy-based aesthetic devices market during the forecast period from 2024 to 2030.
On September 9, 2025, GE HealthCare announced that it had agreed to acquire icometrix, a company specializing in AI-driven brain imaging analysis for neurological disorders such as Alzheimer’s disease. The acquisition aims to address the rising demand for Magnetic Resonance Imaging (MRI) in personalized treatment planning.
To enhance its MR-guided, AI-assisted scanning expertise, GE HealthCare plans to integrate the icometrix icobrain platform into its MRI systems, enabling streamlined workflow for neurological disease assessment and reporting. Notably, icobrain aria includes the first FDA-cleared computer-aided detection and diagnosis solution for identifying and quantifying Amyloid Related Imaging Abnormalities (ARIA), known side effects of amyloid-targeting therapies.
The planned acquisition supports GE HealthCare’s precision care strategy and is expected to expand its clinical decision support capabilities for early diagnosis and ongoing monitoring along the neurology imaging pathway. Combined with its current neuro portfolio, including Brain PET-MRI scanners, pharmaceutical diagnostics, and MIMneuro software for amyloid imaging quantification, the company aims to provide comprehensive neuro solutions for customers.
GE HealthCare also intends to broaden access to icobrain aria across all vendor MRI systems through commercial distribution and clinical integration. The solution detects both ARIA-E and ARIA-H on MR scans, performs longitudinal tracking of abnormalities, and equips radiologists with tools to monitor Alzheimer’s patients undergoing anti-amyloid therapies, supporting both patient outcomes and workflow efficiency. Integration with GE HealthCare’s MR technologies, such as AIR x™ Brain, AIR Recon DL, and SONIC DL 3D, is expected to create a seamless, optimized workflow capable of handling increasing scan volumes without compromising care quality.
The broader icometrix product suite offers solutions that assist radiologists and neurologists in comparing and quantifying brain MR scans over time across conditions such as multiple sclerosis, dementia, epilepsy, stroke, and traumatic brain injury. The suite also includes a strong pipeline of clinical decision support applications under development, aimed at advancing neurological care in the future.
“This effort marks a pivotal step in our journey to advance precision care in neurology,” said Roland Rott, President and CEO, Imaging at GE HealthCare. “By integrating icometrix’s AI-powered insights with our advanced imaging technologies, we aim to empower care teams with the clarity and confidence needed to navigate complex neurological conditions.”
“Along with our commitment to pushing the barriers of neuroscience research with our innovative MRI technology, we’re dedicated to strengthening our neurology portfolio and our MR imaging capabilities to provide advanced solutions to clinicians providing more precise care for patients both now and in the future,” said Kelly Londy, President & CEO, MR, GE HealthCare. “Our anticipated acquisition of Icometrix and its icobrain solutions supports our goal to help clinicians deliver high-quality, timely care to meet this increased demand in MR technology.”
According to DelveInsight’s “Brain Imaging Devices Market Report, the global brain imaging devices market is expected to increase from USD 5,091.71 million in 2024 to USD 7,779.85 million by 2032, reflecting strong and sustained growth. The brain imaging devices market is growing at a CAGR of 5.50% during the forecast period from 2025 to 2032. The global brain imaging devices market is driven by the rising prevalence of neurological disorders, technological advancements, especially AI and ML integration, and increasing product development activities by key market players, including innovations in MRI, CT, and PET technologies.
On September 11, 2025, Diality Inc., a medical device company and developer of the Moda-flx™ Hemodialysis System, announced the initiation of its PRESCRIBE Diality Home Hemodialysis Clinical Trial, marking the first patient treatment in collaboration with aQua Research Institute and aQua Dialysis in Houston, Texas.
The Moda-flx Hemodialysis System is engineered to support kidney care professionals with a versatile range of flow rates, built-in reverse osmosis water purification, and an intuitive graphical user interface. The system offers clinicians the flexibility to tailor each dialysis treatment to individual patient needs within a single, integrated platform. Its compact and mobile design further allows for smooth integration and easy transport across different dialysis care environments.
”Diality’s Moda-flx Hemodialysis System is unique in its ability to offer an integrated reverse osmosis (RO) system combined with dialysis flow rates (Qd) up to 600 mL/min. Moda-flx addresses the gaps that exist between conventional in-center dialysis and current home hemodialysis systems. Those gaps often force clinicians to compromise elements of dialysis care due to the limitations of their technology,” said Diality CEO Dr. Osman Khawar. “We are fortunate to work with clinical partners like aQua Dialysis who are committed to supporting clinical research and home hemodialysis, and improving the dialysis experience for both patients and clinicians.”
“We are excited to partner with Diality in this clinical trial to provide clinicians, patients, and their caregivers with improved technology options to positively impact their day-to-day lives,” said Ivan Ramirez, CEO of aQua Research Institute and Dialysis.
According to DelveInsight’s “Haemodialysis Machines Market Report”, the hemodialysis machines market was valued at USD 13.53 billion in 2023, growing at a CAGR of 4.71% during the forecast period from 2024 to 2030 to reach USD 17.78 billion by 2030. The increase in demand for hemodialysis machines is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition, the constantly increasing old population, high blood pressure, and high diabetes prevalence are also driving factors for hemodialysis machines, as older age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the hemodialysis machines product pipeline and an increase in product approvals are among the other factors responsible for the growth of the global Hemodialysis Machines market during the forecast period from 2024 to 2030.
On September 11, 2025, Teleflex Incorporated, a global leader in medical technologies, announced the enrollment of the first patient in the DUBSTENT DIABETES trial, a randomized, investigator-initiated clinical study designed to assess a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.
The study aims to evaluate the safety and effectiveness of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation, compared to single-device approaches using either DCB or DES alone, in diabetic patients with de novo coronary artery lesions. In the DCB-only arm, the Freesolve™ Resorbable Magnesium Scaffold (RMS) may be employed as a bail-out option to support the “leave-nothing-behind” strategy. This trial addresses a significant unmet need, as diabetic patients continue to face elevated risks of stent failure despite advancements in DES technology.
A total of 120 patients with diabetes will be enrolled across high-volume centers in Ireland. Participants will be randomized to one of three treatment groups. A combination of the Pantera Lux DCB Catheter (part of the Lux family of paclitaxel-coated balloons) and the Orsiro Mission DES, the Pantera Lux DCB Catheter alone, or the Orsiro Mission DES alone.
The trial’s primary endpoint is the percentage diameter stenosis at six months, assessed using quantitative coronary angiography. Secondary endpoints include all-cause death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and patient quality of life, tracked for up to five years.
“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. “By combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested in seeing the impact on restenosis and long-term vessel health in patients with diabetes.”
“We are committed to advancing evidence-based solutions for complex patient populations,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs for Vascular Intervention at Teleflex. “We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.”
According to DelveInsight’s “Drug Eluting Balloons Market Report”, the global drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases, including peripheral and coronary artery diseases. Furthermore, the rising preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and development activities by the key players, among others, are thereby contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2024 to 2030.
Article in PDF
Sep 18, 2025
Table of Contents
On September 17, 2025, Amber Implants, a pioneering medical technology company focused on developing advanced solutions for spinal injuries, announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its VCFix® Spinal System. This milestone validates the device’s safety and efficacy while serving as a globally recognized endorsement of its clinical value, enabling immediate entry into the world’s largest MedTech market.
The VCFix® Spinal System is an innovative vertebral augmentation platform designed to address a wide range of vertebral compression fractures treatment. Offering a minimally invasive approach, it works in conjunction with bone cement to deliver robust anterior and posterior column support. The system integrates smoothly into current surgical practices and has the potential to enhance spinal stabilization, lower patient risk, and reduce procedure times compared to existing treatments.
Clinical data from a one-year follow-up of the initial trials, released in June 2025, highlighted sustained pain reduction, improved spinal stability, and accelerated recovery, emphasizing its long-term functional benefits. Looking ahead, Amber Implants is pursuing CE marking in the European Union, targeting broad indications that support both stand-alone use of VCFix® and its combination with posterior fixation systems.
Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, said, “The VCFix Spinal System is a groundbreaking vertebral augmentation solution with the potential to establish a new standard of care in vertebral fracture management, reinforcing Amber Implants’ role as a global innovator in spinal fracture solutions. The US, as the world’s largest MedTech market, provides an ideal platform for growth with a potential market in excess of €800m, and this clearance lays the foundation to initiate our commercial launch activities.”
Dr. Mohammad Ahmadi, Co-Founder and Chief Technology Officer of Amber Implants, added: “We will begin our US commercial launch with a pilot program in early 2026, accompanied by the expansion of the EXPAND pivotal trial into the US. This will be followed by broader physician availability from later in 2026. At the same time, we continue to pursue EU label expansion for stand-alone use and integration with one-level fixation.”
As per DelveInsight’s “Spinal Implants Market Report,” 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 spinal non-fusion devices 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.
On September 12, 2025, Merit Medical Systems, Inc., a global leader in healthcare technology, announced that its Embosphere® Microspheres have received approval in the European Union for use in genicular artery embolisation (GAE), a minimally invasive treatment for patients with knee osteoarthritis (OA).
Osteoarthritis is the most prevalent form of arthritis, affecting an estimated 595 million people worldwide, with the knee being the joint most commonly impacted. Factors such as an aging population, rising obesity rates, and sports or occupational injuries continue to drive this growing burden, and prevalence is expected to increase further.
An interventional radiologist performs GAE and works by selectively reducing blood flow to the inflamed synovium, the thin joint lining. This approach has been shown to provide substantial pain relief, enhanced mobility and function, and may help delay or even eliminate the need for surgery. As part of the expanding field of musculoskeletal embolisation, GAE reflects the broader trend toward minimally invasive, image-guided pain management therapies.
Clinical data demonstrate that over 75% of patients treated with Embosphere for GAE achieved sustained clinical success, with significant reductions in knee pain lasting up to 24 months. Patients also reported reduced dependence on pain medications and improvements in quality-of-life measures. Notably, compared to corticosteroid injections, GAE with Embosphere delivered consistently superior outcomes, with greater improvements in both pain and quality of life observed as early as three months.
Embosphere is engineered from a proprietary tris-acrylic cross-linked co-polymer and features a uniform spherical shape designed to achieve durable and complete occlusion of target blood vessels. With tighter calibration than other devices, it ensures predictable and reliable performance, a critical factor when treating the small genicular arteries.
Backed by over 25 years of clinical use, Embosphere is one of the most widely studied embolotherapy solutions, with evidence documented in more than 130 pivotal clinical publications and over 800,000 patients treated worldwide. It has demonstrated long-term effectiveness across a wide range of conditions, including uterine fibroids, arteriovenous malformations (AVM), and benign prostatic hyperplasia (BPH).
“This expanded indication underscores our commitment to continued innovation that supports the minimally invasive therapies our healthcare partners provide,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “In the case of Embosphere, a long-standing leader in the embolic space, it remains a trusted solution whose use has grown in ways that have positively impacted patient lives and will pave the way for embolotherapy well into the future.”
As per DelveInsight’s “Minimally Invasive Surgical Devices Market Report,” the global minimally invasive surgical devices market is expected to increase from USD 30,798.01 million in 2024 to USD 53,259.85 million by 2032, growing at a CAGR of 7.13% during the forecast period from 2025 to 2032. The demand for minimally invasive surgical devices is being primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular disorders, among others. Additionally, the global increase in the number of surgical procedures being performed using minimally invasive techniques, coupled with growing technological advancements and an increase in product development activities among the key market players, are key factors contributing to the positive growth of the minimally invasive surgical devices market during the forecast period from 2025 to 2032.
On September 16, 2025, in the expanding sector of non-invasive, energy-based aesthetic treatments, aesthetic laser skin resurfacing has continued to hold a dominant position due to its effectiveness in addressing fine lines, wrinkles, pigmentation issues, acne scars, and sun damage, while also improving overall skin texture and tone. In line with this growing demand, Rejuva Fresh® has further solidified its reputation as a leader in skin resurfacing technologies in North America with the launch of its REVIVO™ Dual Summit 1927/1550 Fractional Laser System.
The REVIVO™ system, introduced as an advanced skin resurfacing solution, combined fractional non-ablative Erbium (1550nm) and micro-ablative and non-ablative Thulium (1927nm) laser technologies. A standout feature of this device was the SPECTRAL MIX mode, which allowed both wavelengths to be used simultaneously, marking a significant improvement over previous technologies like Fraxel Dual, which only enabled the use of one wavelength at a time. This combination made the device particularly effective and customizable for a range of skin concerns and patient profiles.
The system was engineered to deliver fast treatments, minimal downtime, and highly visible results, catering to the needs of modern patients and aesthetic providers. It was also suitable for all Fitzpatrick skin types (I–VI), expanding its usability across diverse populations. Unique features included five specialized treatment heads, three laser output modes, four pulse shape options, and Rejuva Fresh’s proprietary PULSE SHAPE CONTROL technology, which collectively enhanced treatment precision and safety.
With 30 watts of laser power, a larger beam diameter, and an ergonomic roller handpiece, REVIVO™ provided uniform application and effective skin resurfacing in as little as 15–20 minutes. Its ability to deliver ablative, micro-ablative, and non-ablative treatments offered flexibility to providers, enabling them to tailor each session based on the severity of the condition and the patient’s comfort level. Cooling was recommended during treatment to enhance the patient experience.
Clinically, the system was used to treat a broad range of concerns, including wrinkles, sun damage, pigmentation disorders, acne scars, uneven skin tone, and even hair restoration. The 1550nm Erbium wavelength worked on deeper layers of the skin to stimulate collagen and repair dermal damage, while the 1927nm Thulium wavelength targeted the epidermis for pigment correction and texture refinement. In combination, they provided a synergistic effect, breaking down scar tissue, improving tone, and lifting indented acne scars.
In addition to facial resurfacing, REVIVO™ was also applied in scalp treatments for hair restoration, promoting neo-vascularization and enhancing results when used with topical serums. The device’s versatility and effectiveness made it a major advancement in energy-based aesthetic treatment technologies.
Huapei Cai, President and General Manager of Rejuva Fresh LLC Asia Pacific, emphasized: “The REVIVO™ exemplifies our unique collaborations with global manufacturers, integrating advanced engineering with Rejuva Fresh’s deep understanding of provider and patient needs. Our R&D team and clinical specialists worked closely to design effective treatment protocols, just as we did with EMShape® Neo Plus.”
Overall, the launch of the REVIVO™ Dual Summit system marked a significant technological leap in the laser aesthetics industry, offering providers a powerful tool to deliver faster, safer, and more customized skin treatments with minimal recovery time.
According to DelveInsight’s “Energy-based Aesthetic Devices (EAD) Market Report,” the energy-based aesthetic devices market was valued at USD 3.36 billion in 2023, growing at a CAGR of 8.93% during the forecast period from 2024 to 2030, to reach USD 5.60 billion by 2030. The energy-based aesthetic devices market is experiencing significant growth due to the increasing instances of surgical and non-surgical aesthetic procedures, rising efforts by key players to develop and launch new and innovative products, coupled with the preference for minimally invasive procedures, that are acting as major factors contributing to the overall growth of the energy-based aesthetic devices market during the forecast period from 2024 to 2030.
On September 9, 2025, GE HealthCare announced that it had agreed to acquire icometrix, a company specializing in AI-driven brain imaging analysis for neurological disorders such as Alzheimer’s disease. The acquisition aims to address the rising demand for Magnetic Resonance Imaging (MRI) in personalized treatment planning.
To enhance its MR-guided, AI-assisted scanning expertise, GE HealthCare plans to integrate the icometrix icobrain platform into its MRI systems, enabling streamlined workflow for neurological disease assessment and reporting. Notably, icobrain aria includes the first FDA-cleared computer-aided detection and diagnosis solution for identifying and quantifying Amyloid Related Imaging Abnormalities (ARIA), known side effects of amyloid-targeting therapies.
The planned acquisition supports GE HealthCare’s precision care strategy and is expected to expand its clinical decision support capabilities for early diagnosis and ongoing monitoring along the neurology imaging pathway. Combined with its current neuro portfolio, including Brain PET-MRI scanners, pharmaceutical diagnostics, and MIMneuro software for amyloid imaging quantification, the company aims to provide comprehensive neuro solutions for customers.
GE HealthCare also intends to broaden access to icobrain aria across all vendor MRI systems through commercial distribution and clinical integration. The solution detects both ARIA-E and ARIA-H on MR scans, performs longitudinal tracking of abnormalities, and equips radiologists with tools to monitor Alzheimer’s patients undergoing anti-amyloid therapies, supporting both patient outcomes and workflow efficiency. Integration with GE HealthCare’s MR technologies, such as AIR x™ Brain, AIR Recon DL, and SONIC DL 3D, is expected to create a seamless, optimized workflow capable of handling increasing scan volumes without compromising care quality.
The broader icometrix product suite offers solutions that assist radiologists and neurologists in comparing and quantifying brain MR scans over time across conditions such as multiple sclerosis, dementia, epilepsy, stroke, and traumatic brain injury. The suite also includes a strong pipeline of clinical decision support applications under development, aimed at advancing neurological care in the future.
“This effort marks a pivotal step in our journey to advance precision care in neurology,” said Roland Rott, President and CEO, Imaging at GE HealthCare. “By integrating icometrix’s AI-powered insights with our advanced imaging technologies, we aim to empower care teams with the clarity and confidence needed to navigate complex neurological conditions.”
“Along with our commitment to pushing the barriers of neuroscience research with our innovative MRI technology, we’re dedicated to strengthening our neurology portfolio and our MR imaging capabilities to provide advanced solutions to clinicians providing more precise care for patients both now and in the future,” said Kelly Londy, President & CEO, MR, GE HealthCare. “Our anticipated acquisition of Icometrix and its icobrain solutions supports our goal to help clinicians deliver high-quality, timely care to meet this increased demand in MR technology.”
According to DelveInsight’s “Brain Imaging Devices Market Report, the global brain imaging devices market is expected to increase from USD 5,091.71 million in 2024 to USD 7,779.85 million by 2032, reflecting strong and sustained growth. The brain imaging devices market is growing at a CAGR of 5.50% during the forecast period from 2025 to 2032. The global brain imaging devices market is driven by the rising prevalence of neurological disorders, technological advancements, especially AI and ML integration, and increasing product development activities by key market players, including innovations in MRI, CT, and PET technologies.
On September 11, 2025, Diality Inc., a medical device company and developer of the Moda-flx™ Hemodialysis System, announced the initiation of its PRESCRIBE Diality Home Hemodialysis Clinical Trial, marking the first patient treatment in collaboration with aQua Research Institute and aQua Dialysis in Houston, Texas.
The Moda-flx Hemodialysis System is engineered to support kidney care professionals with a versatile range of flow rates, built-in reverse osmosis water purification, and an intuitive graphical user interface. The system offers clinicians the flexibility to tailor each dialysis treatment to individual patient needs within a single, integrated platform. Its compact and mobile design further allows for smooth integration and easy transport across different dialysis care environments.
”Diality’s Moda-flx Hemodialysis System is unique in its ability to offer an integrated reverse osmosis (RO) system combined with dialysis flow rates (Qd) up to 600 mL/min. Moda-flx addresses the gaps that exist between conventional in-center dialysis and current home hemodialysis systems. Those gaps often force clinicians to compromise elements of dialysis care due to the limitations of their technology,” said Diality CEO Dr. Osman Khawar. “We are fortunate to work with clinical partners like aQua Dialysis who are committed to supporting clinical research and home hemodialysis, and improving the dialysis experience for both patients and clinicians.”
“We are excited to partner with Diality in this clinical trial to provide clinicians, patients, and their caregivers with improved technology options to positively impact their day-to-day lives,” said Ivan Ramirez, CEO of aQua Research Institute and Dialysis.
According to DelveInsight’s “Haemodialysis Machines Market Report”, the hemodialysis machines market was valued at USD 13.53 billion in 2023, growing at a CAGR of 4.71% during the forecast period from 2024 to 2030 to reach USD 17.78 billion by 2030. The increase in demand for hemodialysis machines is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition, the constantly increasing old population, high blood pressure, and high diabetes prevalence are also driving factors for hemodialysis machines, as older age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the hemodialysis machines product pipeline and an increase in product approvals are among the other factors responsible for the growth of the global Hemodialysis Machines market during the forecast period from 2024 to 2030.
On September 11, 2025, Teleflex Incorporated, a global leader in medical technologies, announced the enrollment of the first patient in the DUBSTENT DIABETES trial, a randomized, investigator-initiated clinical study designed to assess a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.
The study aims to evaluate the safety and effectiveness of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation, compared to single-device approaches using either DCB or DES alone, in diabetic patients with de novo coronary artery lesions. In the DCB-only arm, the Freesolve™ Resorbable Magnesium Scaffold (RMS) may be employed as a bail-out option to support the “leave-nothing-behind” strategy. This trial addresses a significant unmet need, as diabetic patients continue to face elevated risks of stent failure despite advancements in DES technology.
A total of 120 patients with diabetes will be enrolled across high-volume centers in Ireland. Participants will be randomized to one of three treatment groups. A combination of the Pantera Lux DCB Catheter (part of the Lux family of paclitaxel-coated balloons) and the Orsiro Mission DES, the Pantera Lux DCB Catheter alone, or the Orsiro Mission DES alone.
The trial’s primary endpoint is the percentage diameter stenosis at six months, assessed using quantitative coronary angiography. Secondary endpoints include all-cause death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and patient quality of life, tracked for up to five years.
“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. “By combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested in seeing the impact on restenosis and long-term vessel health in patients with diabetes.”
“We are committed to advancing evidence-based solutions for complex patient populations,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs for Vascular Intervention at Teleflex. “We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.”
According to DelveInsight’s “Drug Eluting Balloons Market Report”, the global drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases, including peripheral and coronary artery diseases. Furthermore, the rising preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and development activities by the key players, among others, are thereby contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2024 to 2030.
