{"id":36410,"date":"2026-11-05T17:24:00","date_gmt":"2026-11-05T11:54:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=36410"},"modified":"2026-11-05T16:24:55","modified_gmt":"2026-11-05T10:54:55","slug":"medtech-news-for-laza-medical-medtronic-setpoint-medical","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical","title":{"rendered":"FX Shoulder Solutions Secures EU MDR Approval for Humelock Reversed; Beckman Coulter Diagnostics Wins FDA Clearance for 15-Minute Bacterial-Viral Assay; Laza Medical Secures Series B Funding of Up to $160 Million to Transform Interventional Imaging; Medtronic Partners with Michael J. Fox Foundation to Expand Parkinson\u2019s DBS Awareness and Reports Significant Blood Pressure Reductions with Symplicity in SPYRAL AFFIRM Real-World Study; SetPoint Medical Marks New Mexico Milestone with First SetPoint\u00ae System Procedures"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6aeca70c1c616\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6aeca70c1c616\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#FX_Shoulder_Solutions_Inc_Achieved_EU_MDR_Certification_for_Humelock_Reversed%C2%AE_Shoulder_System\" >FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed\u00ae Shoulder System&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#Beckman_Coulter_Diagnostics_Received_US_FDA_Clearance_for_Rapid_Bacterial_vs_Viral_Assay_Providing_Results_in_as_Little_as_15_Minutes_for_Adults_and_Children\" >Beckman Coulter Diagnostics Received U.S. FDA Clearance for Rapid Bacterial vs. Viral Assay Providing Results in as Little as 15 Minutes for Adults and Children<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#Laza_Medical_Raised_Up_to_160_Million_in_Series_B_Financing_Led_by_GE_HealthCare_to_Advance_Intelligent_Imaging_for_Transforming_the_Cath_Lab\" >Laza Medical Raised Up to $160 Million in Series B Financing Led by GE HealthCare to Advance Intelligent Imaging for Transforming the Cath Lab&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#Medtronic_and_Michael_J_Fox_Foundation_Partnered_to_Help_More_People_with_Parkinsons_Understand_Deep_Brain_Stimulation\" >Medtronic and Michael J. Fox Foundation Partnered to Help More People with Parkinson&#8217;s Understand Deep Brain Stimulation&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#Medtronic_Symplicity_Blood_Pressure_Procedure_Showed_Significant_Blood_Pressure_Drops_in_SPYRAL_AFFIRM_Real-World_Study\" >Medtronic Symplicity Blood Pressure Procedure Showed Significant Blood Pressure Drops in SPYRAL AFFIRM Real-World Study&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-laza-medical-medtronic-setpoint-medical\/#SetPoint_Medical_Announces_First_SetPoint%C2%AE_System_Procedures_in_New_Mexico_Performed_at_University_of_New_Mexico_Hospital\" >SetPoint Medical Announces First SetPoint\u00ae System Procedures in New Mexico, Performed at University of New Mexico Hospital<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fx-shoulder-solutions-inc-achieved-eu-mdr-certification-for-humelock-reversed-shoulder-system-nbsp\"><span class=\"ez-toc-section\" id=\"FX_Shoulder_Solutions_Inc_Achieved_EU_MDR_Certification_for_Humelock_Reversed%C2%AE_Shoulder_System\"><\/span><strong>FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed\u00ae Shoulder System&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 03 November 2026, FX Shoulder Solutions, Inc. received European Union Medical Device Regulation (EU MDR 2017\/745) certification for its Humelock Reversed Shoulder System, marking an important regulatory milestone in the company&#8217;s international expansion strategy. The certification supported the company&#8217;s efforts to harmonize its shoulder reconstruction portfolio across global markets while ensuring continued product availability and facilitating the introduction of updated surgical instruments and additional implant configurations.&nbsp;<\/p>\n\n\n\n<p>The system, which formed part of the company&#8217;s reverse shoulder replacement portfolio, was supported by post-market clinical follow-up data involving 138 patients monitored for at least three years. The study reported an overall implant revision rate of 2.17%, a device-related revision rate of 1.45%, and an instability-related revision rate of 0.72%, with no reported cases of implant migration or subsidence. This regulatory achievement strengthened FX Shoulder Solutions&#8217; position in the shoulder reconstruction segment and supported its plans to expand its range of shoulder arthroplasty solutions across international markets.<\/p>\n\n\n\n<p><em>&#8220;This achievement is an important milestone in our global strategy and represents the first step toward a more unified FX portfolio across international markets,&#8221; said Baptiste Martin, CEO of FX Shoulder Solutions. &#8220;We have built our reputation on challenging conventional approaches to shoulder arthroplasty through meaningful innovation. As one of the fastest-growing and most innovative portfolios in the industry, our focus is not simply on expanding the number of products we offer, but on ensuring that surgeons worldwide have access to comprehensive solutions supported by clinical evidence, surgical flexibility, and efficient instrumentation.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/shoulder-replacement-devices-market\"><strong>Shoulder Replacement Devices Market Report<\/strong><\/a>,\u201d the shoulder replacement devices market was valued at <strong>USD 1.68 billion<\/strong> in 2023, growing at a <strong>CAGR of 7.27%<\/strong> during the forecast period from 2024 to 2030, to reach <strong>USD 2.54 billion<\/strong> by 2030. The shoulder replacement devices market is experiencing significant growth owing to the widespread instances of shoulder injuries and degenerative conditions like osteoarthritis and rheumatoid arthritis, the rise in product development &amp; innovation activities, among others that are acting as key factors, contributing to the market growth of the shoulder replacement devices market during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-beckman-coulter-diagnostics-received-u-s-fda-clearance-for-rapid-bacterial-vs-viral-assay-providing-results-in-as-little-as-15-minutes-for-adults-and-children\"><span class=\"ez-toc-section\" id=\"Beckman_Coulter_Diagnostics_Received_US_FDA_Clearance_for_Rapid_Bacterial_vs_Viral_Assay_Providing_Results_in_as_Little_as_15_Minutes_for_Adults_and_Children\"><\/span><strong>Beckman Coulter Diagnostics Received U.S. FDA Clearance for Rapid Bacterial vs. Viral Assay Providing Results in as Little as 15 Minutes for Adults and Children<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 27 October 2026, Beckman Coulter Diagnostics received U.S. FDA clearance for its Access MeMed BV assay, a rapid blood-based diagnostic test developed in collaboration with MeMed to distinguish bacterial infections from viral infections in adult and pediatric patients. The automated assay measured three immune-response proteins, including TRAIL, IP-10, and CRP, to determine the likelihood of bacterial infection. It delivered results in as little as 15 minutes when operated on the DxI 9000 analyzer and was also compatible with the Access 2 immunoassay analyzer, allowing hospitals to incorporate the test into their existing laboratory infrastructure without purchasing additional equipment.&nbsp;<\/p>\n\n\n\n<p>The assay was cleared for patients aged 90 days and older with suspected acute infections and supported clinical decision-making in emergency departments, urgent care facilities, and hospital settings. Its introduction was expected to help healthcare professionals differentiate between bacterial and viral infections more efficiently, reduce unnecessary antibiotic prescriptions, and improve antimicrobial stewardship. Furthermore, published health-economic findings indicated that incorporating the test into diagnostic workflows could reduce antibiotic consumption and healthcare expenditure by minimizing avoidable hospital admissions and additional testing.<\/p>\n\n\n\n<p><em>&#8220;By delivering bacterial and viral differentiation in as little as 15 minutes on the DxI 9000 Analyzer, we&#8217;re helping give clinicians greater confidence to make timely, appropriate treatment decisions,&#8221; said Melissa Naiman, Senior Director, Medical &amp; Scientific Affairs, Acute Care at Beckman Coulter Diagnostics. &#8220;That added confidence can be particularly valuable when deciding whether antibiotics are appropriate, helping support responsible antibiotic use while ensuring patients, including children as young as 90 days old, who need antibiotics receive the care they need.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/clinical-diagnostics-market\"><strong>Clinical Diagnostics Market Report<\/strong><\/a>,\u201d the global clinical diagnostics market was valued at <strong>USD 70.11 billion<\/strong> in 2023, growing at a <strong>CAGR of 7.02%<\/strong> during the forecast period from 2024 to 2030. The escalating demand for clinical diagnostics is primarily attributed to the rising burden of various chronic disorders such as liver disorders, blood disorders, and cancer, among others. In addition, an increase in the adoption of point-of-care clinical diagnostic tests, rising strategic business activities for establishing new clinical diagnostic labs worldwide, and growing technological advancement in the product portfolio, among others, are expected to bolster the global clinical diagnostic market during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-laza-medical-raised-up-to-160-million-in-series-b-financing-led-by-ge-healthcare-to-advance-intelligent-imaging-for-transforming-the-cath-lab-nbsp\"><span class=\"ez-toc-section\" id=\"Laza_Medical_Raised_Up_to_160_Million_in_Series_B_Financing_Led_by_GE_HealthCare_to_Advance_Intelligent_Imaging_for_Transforming_the_Cath_Lab\"><\/span><strong>Laza Medical Raised Up to $160 Million in Series B Financing Led by GE HealthCare to Advance Intelligent Imaging for Transforming the Cath Lab&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 04 November 2026, Laza Medical, Inc. secured up to $160 million in Series B structured financing, led by GE HealthCare, with participation from existing investors Unorthodox Ventures, PA MedTech, and AMED. The funding was intended to accelerate the development of its artificial intelligence (AI)-powered robotic imaging technology for cardiovascular interventions. The company focused on integrating AI and robotics into cardiac catheterization laboratories to simplify complex procedures, improve imaging consistency, enhance procedural efficiency, and address the shortage of specialized imaging expertise. Its technology was also expected to support improved navigation during complex cardiac interventions and establish a foundation for future robotic-assisted procedures. This investment strengthened the development of advanced imaging solutions for interventional cardiology and highlighted the growing adoption of AI and robotics in cardiovascular care. However, Laza Medical&#8217;s imaging system was still under development and had not received regulatory approval for commercial sale in any geography.<\/p>\n\n\n\n<p><em>&#8220;The future of cardiac intervention must be one where access, consistency, and quality of care are no longer barriers to better outcomes,&#8221; stated Jyoti Gera, CEO of Cardiovascular and Interventional Solutions, Advanced Imaging Solutions at GE HealthCare. &#8220;Integrating imaging modalities so they work seamlessly together has the potential to redefine the cath lab, enabling more efficient workflows today and paving the way for smarter, robotic procedures tomorrow. We&#8217;re excited to expand our collaboration with Laza and work together toward this shared vision.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/artificial-intelligence-ai-in-medical-imaging-market\"><strong>Artificial Intelligence (AI) in Medical Imaging Market Report<\/strong><\/a>,\u201d the global artificial intelligence in medical imaging market is expected to increase from <strong>USD 1,673.03 million<\/strong> in 2024 to <strong>USD 13,181.93 million<\/strong> by 2032, reflecting strong and sustained growth. The global artificial intelligence in medical imaging market is growing at a <strong>CAGR of 29.48% <\/strong>during the forecast period from 2025 to 2032. The global artificial intelligence in medical imaging market is being driven by the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which increase demand for accurate and efficient diagnostics. Government initiatives and funding are promoting healthcare digitization and AI adoption, while key players are investing in product development and strategic collaborations to enhance imaging solutions. Rapid advancements in deep learning, machine learning, and computer vision are further improving diagnostic accuracy, workflow efficiency, and predictive capabilities, collectively accelerating market growth across regions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-medtronic-and-michael-j-fox-foundation-partnered-to-help-more-people-with-parkinson-s-understand-deep-brain-stimulation-nbsp\"><span class=\"ez-toc-section\" id=\"Medtronic_and_Michael_J_Fox_Foundation_Partnered_to_Help_More_People_with_Parkinsons_Understand_Deep_Brain_Stimulation\"><\/span><strong>Medtronic and Michael J. Fox Foundation Partnered to Help More People with Parkinson&#8217;s Understand Deep Brain Stimulation&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 04 November 2026, Medtronic partnered with The Michael J. Fox Foundation for Parkinson&#8217;s Research (MJFF) to expand awareness and understanding of deep brain stimulation (DBS) therapy among people living with Parkinson&#8217;s disease and their caregivers. The collaboration focused on developing educational resources, including an online information hub, practical guides, interactive webinars, and additional educational programmes to help patients understand the procedure, its potential benefits and risks, surgical preparation, and post-implantation care. Medtronic supported the initiative through its extensive experience of more than 30 years in DBS therapy, having served over 200,000 individuals with movement disorders and other conditions globally. The initiative also aimed to help patients make informed treatment decisions and encourage discussions with healthcare professionals regarding available therapeutic options. Furthermore, the partnership highlighted the growing importance of neuromodulation technologies in managing Parkinson&#8217;s disease symptoms and improving patient access to advanced neurological treatments.<\/p>\n\n\n\n<p><em>&#8220;Our urgent mission is to accelerate a cure for Parkinson&#8217;s by advancing the most promising research. Partnerships with industry help us do more for people and families by expanding access to clear, practical resources that support informed decisions and meaningful participation in our mission,&#8221; said Sohini Chowdhury, MJFF&#8217;s chief program officer. &#8220;Together with Medtronic, we&#8217;re creating robust educational materials to help people explore what DBS may offer and to keep them updated on the latest scientific progress.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/deep-brain-stimulation-devices-market\"><strong>Deep Brain Stimulation Devices Market Report<\/strong><\/a>\u201d, the deep brain stimulation (DBS) devices market size was estimated at <strong>USD 1,462.96 million<\/strong> in 2025 and is projected to grow at a <strong>CAGR of 9.24%<\/strong> during the forecast period from 2026 to 2034, reaching approximately<strong> USD 3,217.14 million<\/strong> by 2034. The demand for deep brain stimulation (DBS) devices is experiencing growth due to the increasing prevalence of neurological disorders, such as Parkinson\u2019s disease and epilepsy. The rising geriatric population, which is more susceptible to these disorders, is a major factor driving this trend. Additionally, the growing focus on research and development (R&amp;D) and technological advancements in product innovation are contributing significantly to the positive growth of the deep brain stimulation devices market during the forecast period from 2026 to 2034.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-medtronic-symplicity-blood-pressure-procedure-showed-significant-blood-pressure-drops-in-spyral-affirm-real-world-study-nbsp\"><span class=\"ez-toc-section\" id=\"Medtronic_Symplicity_Blood_Pressure_Procedure_Showed_Significant_Blood_Pressure_Drops_in_SPYRAL_AFFIRM_Real-World_Study\"><\/span><strong>Medtronic Symplicity Blood Pressure Procedure Showed Significant Blood Pressure Drops in SPYRAL AFFIRM Real-World Study&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 03 November 2026, Medtronic plc announced positive six-month results from its SPYRAL AFFIRM post-approval study, evaluating the effectiveness of its Symplicity Spyral renal denervation (RDN) system in patients with uncontrolled hypertension. The study demonstrated statistically significant and clinically meaningful reductions in blood pressure across office-based, home, and 24-hour ambulatory measurements without an increase in antihypertensive medication use. The findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference and were simultaneously published in Circulation: Cardiovascular Interventions.&nbsp;<\/p>\n\n\n\n<p>At six months, patients treated with the system experienced an 18.2 mmHg reduction in office systolic blood pressure, a 9.4 mmHg reduction in home systolic blood pressure, and a 9.7 mmHg reduction in 24-hour ambulatory systolic blood pressure. Approximately 86% of evaluable patients experienced a clinical benefit, with similar blood pressure reductions observed across diverse patient groups, including women, Black and Hispanic patients, and individuals aged 65 years and older. The study also demonstrated a favorable safety profile, with the composite safety endpoint occurring in 2.1% of patients. Additionally, Medtronic received U.S. FDA approval for an update to the Symplicity Spyral catheter&#8217;s labeling, incorporating additional clinical evidence in patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes. These findings strengthened the clinical evidence supporting renal denervation as an additional treatment option for patients with uncontrolled hypertension, potentially increasing physician confidence and adoption of the technology.<\/p>\n\n\n\n<p><em>&#8220;The blood pressure reductions achieved with RDN in the AFFIRM study are transformative. In fact, they are within the range associated with a greater than 20% reduction in major adverse cardiovascular events, underscoring the clinical significance of these results,&#8221; said Dr. David Kandzari, chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL AFFIRM study. &#8220;Importantly, the study also demonstrated significant reductions in home blood pressure, offering insight into how patients are responding beyond the clinical setting and in their everyday lives. These findings reinforce the potential benefit of renal denervation in combination with lifestyle changes and medication for patients who continue to struggle with uncontrolled hypertension.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/renal-denervation-devices-market\"><strong>Renal Denervation Devices Market Report<\/strong><\/a>\u201d, the global renal denervation devices market is estimated to grow at a <strong>CAGR of 14.34%<\/strong> during the forecast period from 2025 to 2032. The rising prevalence of hypertension and the growing incidence of cardiovascular diseases closely linked to uncontrolled blood pressure are significantly driving the demand for renal denervation devices. Additionally, the expansion of these devices into other clinical applications, such as heart failure and chronic kidney disease, has broadened their market potential. Continuous advancements in technology and increased product development activities by key players globally are further enhancing the safety, efficacy, and adoption of these devices, collectively fueling the growth of the renal denervation devices market during the forecast period from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-setpoint-medical-announces-first-setpoint-system-procedures-in-new-mexico-performed-at-university-of-new-mexico-hospital\"><span class=\"ez-toc-section\" id=\"SetPoint_Medical_Announces_First_SetPoint%C2%AE_System_Procedures_in_New_Mexico_Performed_at_University_of_New_Mexico_Hospital\"><\/span><strong>SetPoint Medical Announces First SetPoint\u00ae System Procedures in New Mexico, Performed at University of New Mexico Hospital<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 03 November 2026, SetPoint Medical announced the completion of the first procedures using its FDA-approved SetPoint System in New Mexico at the University of New Mexico Hospital in Albuquerque. The procedures were performed by a neurosurgeon in collaboration with rheumatology specialists to provide an additional treatment option for eligible adults suffering from moderately to severely active rheumatoid arthritis.&nbsp;<\/p>\n\n\n\n<p>The SetPoint System incorporated a miniaturized implantable neurostimulator that delivered targeted electrical stimulation to the left vagus nerve, activating the body&#8217;s natural anti-inflammatory pathways and helping regulate immune activity associated with rheumatoid arthritis. The therapy was intended for patients who had experienced inadequate responses, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The first procedures in New Mexico represented another step in the company&#8217;s geographical expansion and increased the availability of device-based neuroimmune modulation therapy for eligible rheumatoid arthritis patients. The development also highlighted the growing application of bioelectronic medicine and neuromodulation technologies beyond traditional neurological disorders, particularly in the management of chronic autoimmune diseases.<\/p>\n\n\n\n<p><em>&#8220;Treating rheumatoid arthritis has not traditionally been part of a neurosurgeon&#8217;s practice, and that is what makes this therapy so different,&#8221; said Dr. Botros. &#8220;The vagus nerve plays an important role in regulating inflammation, and the SetPoint System allows us to engage that pathway directly. Having worked with this system since its clinical investigation, I look forward to seeing this collaboration with rheumatology continue to grow at UNM Hospital.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/vagus-nerve-stimulator-market\"><strong>Vagus Nerve Stimulator (VNS) Market Report<\/strong><\/a>,\u201d the global vagus nerve stimulators market was valued at <strong>USD 1,011.97 million<\/strong> in 2025, growing at a <strong>CAGR of 10.88%<\/strong> during the forecast period from 2026 to 2034 to reach <strong>USD 2,536.47 million<\/strong> by 2034. The demand for vagus nerve stimulators is witnessing a surge primarily due to the rising prevalence of neurological diseases such as epilepsy, headache disorders such as migraine, and others that have proven to receive benefit from VNS therapy, increasing popularity of VNS therapy as an alternative or even conjunctive treatment in cases where drug resistance develops, growing research in studying the effects of VNS on other indications such as tinnitus and chronic pain besides the approved ones, technological advancements leading to the development of new products such as non-invasive VNS devices thereby boosting the growth of the vagus nerve stimulators market during the forecast period from 2026 to 2034.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FX Shoulder Solutions, Inc. Achieved EU MDR Certification for Humelock Reversed\u00ae Shoulder System&nbsp; On 03 November 2026, FX Shoulder Solutions, Inc. received European Union Medical Device Regulation (EU MDR 2017\/745) certification for its Humelock Reversed Shoulder System, marking an important regulatory milestone in the company&#8217;s international expansion strategy. The certification supported the company&#8217;s efforts to [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":36412,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[22784,19330,16926,17021,16975,21408,19765,17101],"industry":[17226],"therapeutic_areas":[17245],"class_list":["post-36410","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-ai-in-medical-imaging","tag-clinical-diagnostics","tag-deep-brain-stimulation-devices","tag-medical-devices-market","tag-medtech-market","tag-renal-denervation-devices","tag-shoulder-replacement-devices","tag-vagus-nerve-stimulator-market","industry-medical-devices","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MedTech News | Laza Medical, Medtronic, SetPoint Medical<\/title>\n<meta name=\"description\" content=\"FX Shoulder Solutions\u2019 Humelock Reversed Shoulder System; 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