The new XTRAC Momentum™ 1.0 embodies cutting-edge excimer laser technology, featuring increased power and a quicker repetition rate compared to its predecessors. It introduced a revamped user interface and a sleeker design, aimed at enhancing the treatment process for users. STRATA’s excimer devices were utilized in more than 300 hospitals and private practice dermatology clinics across Japan.
STRATA’s XTRAC excimer laser technology enabled the precise delivery of targeted UVB light therapy to specific areas of the skin. This treatment is beneficial for adult and pediatric patients dealing with inflammatory skin conditions like psoriasis, atopic dermatitis, and vitiligo.
As per DelveInsight’s “Dermatology Devices Market Report,” the global dermatology devices market was valued at USD 6.27 billion in 2023, growing at a CAGR of 12.47% during the forecast period from 2024 to 2030 to reach USD 12.69 billion by 2030. Factors such as the growing prevalence of chronic skin problems such as acne, atopic dermatitis, and psoriasis among others, further increasing awareness of skin care, and the growing focus on improving the safety and usability of dermatology devices for end-users are further expected to result in the appreciable revenue growth in the dermatology devices market.
eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device, Bringing Expertise in Surgical Navigation And Robotics
On July 22, 2024, eCential Robotics, a US-based company pioneering in surgical robotics, announced the FDA’s 510(k) clearance for its innovative Spine Navigation and Robotic-Assistance Device. This approval marks a significant advancement in spinal fusion procedure planning and instrumentation, showcasing eCential Robotics’ expertise in surgical navigation and robotics. It underscores the company’s commitment to enhancing and advancing healthcare through cutting-edge technology.
“This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation,” said Clément Vidal, CEO at eCential Robotics. “We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes.”
eCential Robotics shifted its focus towards advancing the commercialization of its distinctive Open eCential Platform in the United States. The company aims to collaborate with implant manufacturers and technology firms to broaden the array of applications accessible on the Platform.
As per 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 7.38% during the forecast period 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 incidences of orthopedic disorders, especially among the geriatric population, along with increasing demand for minimally invasive surgical procedures, and growing activities for research and development for surgical navigation systems are thereby contributing to the overall growth of the surgical navigation systems market.
MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device in Intracranial Aneurysms (CLEVER) study, showcased the Device’s Effectiveness Over One Year in Treating Both Ruptured and Unruptured Aneurysms
On July 23, 2024, MicroVention, Inc., a worldwide leader in neurovascular solutions, announced the publication of the results from the CLinical EValuation of WEB 17 Device in Intracranial Aneurysms (CLEVER): one-year effectiveness results for ruptured and unruptured aneurysms study. This multicenter, prospective study examined the safety and effectiveness of the WEB 17 system in treating both ruptured and unruptured aneurysms, focusing on assessing the newest and smallest WEB system.
Prof. Laurent Spelle, a contributor from the CLEVER study made the following comments about the WEB technology and the clinical data supporting it: “One-year angiographic results of CLEVER show excellent complete occlusion rates at one year in the population of wide-neck bifurcation aneurysms treated with WEB 17,” said Prof. Laurent Spelle, Professor & Chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University.
Dr. Adam Arthur, Principal Investigator for the WEB-IT Trial, which was the US IDE study to support WEB PMA approval in the US, also commented: “WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” said Dr. Adam Arthur, James T Robertson Professor and Chair at The University of Tennessee Health Science Center.
The CLEVER study involved 163 patients across 17 European centers and concluded that the WEB 17 device is as safe and effective as previous generations, with a low complication rate and no instances of rebleeding at 30 days and one year. At one-year follow-up, the occlusion rates were satisfactory: 86.5% for ruptured aneurysms (73.1% achieving complete occlusion) and 82.4% for unruptured aneurysms (57.1% achieving complete occlusion). These findings affirm that the WEB 17 system maintains comparable efficacy to earlier WEB generations.
“MicroVention’s WEB Aneurysm Embolization System is now the most studied intrasaccular device available today, underscoring our commitment to physicians and patients alike to provide innovative, advanced medical device technology coupled with long-term safety and effectiveness,” said Carsten Schroeder, President and CEO, MicroVention, Inc. “With over 10,000 units sold in the United States, WEB advances treatment of wide-neck bifurcation aneurysms with one intrasaccular device – clinically proven one and done treatment. We will continue to work side-by-side with leading physicians around the world to identify the evolving needs in patient care, and then transform those insights into innovative technologies that help to save patient lives.”
The WEBTM Embolization System stands out as the most extensively researched intravascular device on the market, supported by seven good clinical practice (GCP) studies and over 200 peer-reviewed publications. It represents a pioneering intravascular technology providing a single-device solution for wide-neck bifurcation aneurysms, thereby reducing the necessity for a dual antiplatelet regimen required with intraluminal therapies.
The WEB Aneurysm Embolization System is approved for use in treating adult patients with saccular, wide-neck bifurcation intracranial aneurysms at specific locations: the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex. These aneurysms typically have a dome diameter ranging from 3 mm to 10 mm and either a neck size of 4 mm or greater or a dome-to-neck ratio greater than 1 and less than 2.
According to DelveInsight’s “Intracranial Aneurysms Market Report”, the global intracranial aneurysms market was valued at USD 1.13 billion in 2023, growing at a CAGR of 9.10% during the forecast period from 2024 to 2030, to reach USD 1.90 billion by 2030. The rise in the market for intracranial aneurysms is primarily due to the rising prevalence of abnormalities in blood vessels present in the brain, counting brain aneurysms and arteriovenous malformations (AVMs) owing to sedentary lifestyles. Furthermore, an increase in high blood pressure among the population, approval, and launch of various intracranial aneurysm treatment devices, and rising research and development activities for the development of intracranial aneurysm treatment devices, among others are anticipated to bolster the global intracranial aneurysm market.
Neuspera Medical, Inc. Reached Significant Achievement: Final Patient Completed Primary Endpoint Visit in the SANS-UUI Pivotal Clinical Trial
On July 23, 2024, Neuspera Medical, Inc., a company pioneering in neuromodulation devices, achieved a significant milestone. The company mentioned that all patients implanted with the Neuspera Implantable Sacral Neuromodulation (SNM) System have completed the 6-month primary endpoint visit in the pivotal SANS-UUI trial. The Neuspera System, a discreet and minimally invasive implant of ultra-miniaturized design, aims to offer patients personal control and relief from urinary urge incontinence (UUI), a common symptom of overactive bladder (OAB).
The clinical data from this trial will support Neuspera’s submission to the U.S. Food and Drug Administration (FDA) for regulatory approval to treat OAB symptoms. Overactive bladder (OAB) is a prevalent medical condition that affects approximately one in six adults. Its symptoms include sudden and uncontrollable urges to urinate, urine leakage, and frequent urination throughout the day and night. The Neuspera System is FDA cleared for treating chronic pain of peripheral nerve origin. It is being investigated as a device for treating urinary urge incontinence (UUI), a symptom associated with overactive bladder (OAB).
“We’re grateful to every physician and patient who participated in the clinical trial, and we’re excited that our uniquely differentiated technology will help millions of patients when it is FDA-approved for treatment of OAB symptoms,” said Steffen Hovard, CEO of Neuspera Medical. “The fact that the market is only 5% penetrated at this time is a clear indication that patients are looking for something different than what’s available today. The Neuspera System delivers true innovation.”
Sacral neuromodulation (SNM) is widely acknowledged as the “gold standard” therapy for overactive bladder (OAB). Neuspera’s system, distinguished by its significantly smaller implant and incision size compared to existing options, offers efficacy that aligns with top SNM data. The company anticipates substantial advantages from new guidelines facilitating quicker patient access to minimally invasive treatments previously classified as “third line.
The SANS-UUI study, conducted across multiple centers as a single-arm clinical trial, aimed to establish the safety and effectiveness of the Neuspera System for FDA approval in the United States. Patients underwent screening and device implantation at 26 centers located in the U.S. and Europe. Participants from the Phase One clinical trial, some of whom have been managing their urinary urge incontinence (UUI) symptoms with the Neuspera System successfully for up to 3.5 years, have described the device as “life-changing,” “miraculous,” and “easy to use.”
“Reaching the final patient’s primary endpoint visit for the clinical trial is an important milestone in Neuspera’s journey towards revolutionizing the way physicians utilize SNM therapy,” said Dr. Steve Siegel, chief medical officer of Neuspera Medical. “This will be a great solution for patients who want a high degree of symptom control with the smallest implantable neurostimulator available, designed to empower patients and provide ultimate discreetness putting control of life-altering symptoms in patients’ hands.”
“As the coordinating investigator for the SANS-UUI clinical trial, based on my experience with the Neuspera System and how patients are responding, I’m excited to soon be able to offer an OAB treatment option that truly gives patients control of their bladders in the least invasive way with the ability to self-administer their therapy when it’s convenient for them, and nobody else can see or feel it,” said Dr. Osvaldo Padron with Florida Urology Partners.
According to DelveInsight’s “Stress Urinary Incontinence Devices Market Report”, the stress urinary incontinence devices market was valued at USD 5.82 billion in 2023, growing at a CAGR of 11.77% during the forecast period from 2024 to 2030, to reach USD 11.34 billion by 2030. The stress urinary incontinence devices market is witnessing positive growth owing to the rising prevalence of urinary incontinence cases among women, a surge in the aging population prone to stress urinary incontinence and weakening of the pelvic floor, the development of innovative devices, physical problems caused due to conditions including pregnancy, diabetes, menopause, pushes the demand of these devices, thereby contributing to the growth of the stress urinary incontinence devices market.
GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business from Intelligent Ultrasound, Enhancing GE Healthcare’s Array of AI-enabled Devices with Advanced Expertise
On July 9, 2024, GE HealthCare, a leader in medical technology, announced its agreement to acquire Intelligent Ultrasound Group PLC’s (Intelligent Ultrasound) clinical artificial intelligence (AI) software business for approximately $51 million. Through this acquisition, GE HealthCare aims to enhance its AI-based technology from Intelligent Ultrasound, focusing on real-time support for OBGYN scans to improve exam accuracy and efficiency. This strategic move supports GE HealthCare’s precision care strategy, addressing inefficiencies in healthcare delivery and aiming to elevate the quality of patient care.
“We are pleased to bring innovative technology from Intelligent Ultrasound into GE HealthCare’s Ultrasound portfolio, allowing us to fully integrate these solutions into our systems to help clinicians improve workflow, reduce repetitive tasks, and simplify exams,” said Phil Rackliffe, president and CEO of Ultrasound and Image Guided Therapies, GE HealthCare. “This technology and the experts who developed it will help enhance our portfolio of AI-enabled devices and accelerate our pace of development of next-generation AI tools.”
“I really believe that we are at the start of a wave of AI making a profound difference to medical imaging, and especially ultrasound,” said Nick Sleep, Chief Operating Officer, Intelligent Ultrasound, who will join GE HealthCare. “Becoming part of the GE HealthCare family will help speed the adoption of this technology and make ultrasound even easier for customers to use.”
This agreement strengthened GE HealthCare’s portfolio of AI-enabled devices, placing it at the forefront of the FDA’s list of AI-enabled device authorizations among medical technology companies. It also reinforces the company’s precision care strategy, aimed at resolving inefficiencies in clinical care workflows and elevating patient care quality throughout the care continuum.
Following the sale of its clinical AI business to GE HealthCare, Intelligent Ultrasound will refocus on its advanced ultrasound simulation technology, renowned for its high fidelity and designed to enhance ultrasound education.
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market size is estimated at USD 6.76 billion in 2023 and is expected to reach USD 6.82 billion by 2030, growing at a CAGR of 10.05% during the forecast period from 2024 to 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.
Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch to Enhance Safety of ICU Patients
On July 23, 2024, Sutter Health, a company specializing in healthcare delivery system, announced the deployment of its FloPatch. FloPatch represents a groundbreaking advancement as the world’s first wireless, wearable Doppler ultrasound device. Cleared by the FDA, it provides ICU clinicians with a rapid, hands-free solution for assessing blood flow at the bedside. This capability is crucial in guiding cardiopulmonary resuscitation and fluid management strategies for critically ill patients, enhancing the precision and efficiency of critical care interventions.
“Sepsis, hypotension/shock and renal failure are common clinical problems in the emergency department and ICU. FloPatch can make a large impact on patient care by allowing goal directed care which will prevent potentially harmful interventions and, in some cases, may avoid the need for ICU-level care,” said Kristina Kury, M.D., medical director of Critical Care at Sutter’s Eden Medical Center. “I believe this technology will provide more precise, actionable data that will allow us to optimize patient care, decrease complications and decrease length of stay for many of our patients.”
“Based on our early experience using FloPatch, we believe it will be as effective in managing the care of ICU patients with congestive heart failure and other shock conditions as with sepsis,” said George S. Horng, M.D., medical director of Critical Care at Sutter’s CPMC. “This is a non-invasive breakthrough that will lead to better health outcomes for our patients.”
“We’re thrilled to partner with Sutter Health to make this pioneering ultrasound technology available to their clinicians,” said Joe Eibl, PhD, CEO of Flosonics Medical. “FloPatch is a new paradigm linking physiology and resuscitation medicine. We believe it can revolutionize treatment for critical care patients by bringing much-needed insight to the most complex and urgent medical scenarios.”
FloPatch revolutionizes IV fluid management in critical care by offering a straightforward, rapid, and reliable method to monitor blood flow and heart function changes tied to IV fluid levels. This innovation enhances precision in patient care, particularly for those with conditions like septic shock, a leading cause of hospital mortality in the U.S.
Positioned on the neck, FloPatch provides continuous, hands-free assessment of carotid artery blood flow, offering insights into left ventricle function. Its wireless transmission to a secure iOS app delivers actionable, real-time data to clinicians at the bedside, empowering swift and informed decision-making.
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market size is estimated at USD 6.76 billion in 2023 and is expected to reach USD 6.82 billion by 2030, growing at a CAGR of 10.05% during the forecast period from 2024 to 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.
