{"id":36457,"date":"2026-11-12T17:28:00","date_gmt":"2026-11-12T11:58:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=36457"},"modified":"2026-11-12T17:09:14","modified_gmt":"2026-11-12T11:39:14","slug":"medtech-news-for-bechtel-medical-mrp-calibermri","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-bechtel-medical-mrp-calibermri","title":{"rendered":"FX Shoulder Solutions Secures EU MDR Certification for Humelock Reversed\u00ae Shoulder System; Bechtel Medical&#8217;s Wound VOX\u2122 Receives FDA 510(k) Clearance; MRP Launches VYDENCE ZYE Ultra Multi-Platform Aesthetic Laser System; Health Canada Authorizes Moderna&#8217;s mRNA Flu and Flu-COVID-19 Vaccines; i-Lumen Presents i-SIGHT Feasibility Study Findings at CTS Retina 2026; CaliberMRI Launches Quantitative MRI Phantom for Preclinical High-Field Systems"},"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-6af5aa8951d7d\" 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-6af5aa8951d7d\"  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-bechtel-medical-mrp-calibermri\/#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-bechtel-medical-mrp-calibermri\/#Bechtel_Medical_Received_FDA_Clearance_for_Wound_VOX%E2%84%A2_the_First_510k-Cleared_Combined_Negative_Pressure_and_Topical_Oxygen_System\" >Bechtel Medical Received FDA Clearance for Wound VOX\u2122, the First 510(k)-Cleared Combined Negative Pressure and Topical Oxygen System&nbsp;<\/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-bechtel-medical-mrp-calibermri\/#MRP_Announced_the_Launch_of_VYDENCE_ZYE_Ultra_an_Advanced_Multi-Platform_Laser_System_Designed_to_Expand_Treatment_Possibilities_for_Aesthetic_Practices\" >MRP Announced the Launch of VYDENCE ZYE Ultra, an Advanced Multi-Platform Laser System Designed to Expand Treatment Possibilities for Aesthetic Practices&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-bechtel-medical-mrp-calibermri\/#CaliberMRI_Announced_Release_of_a_Preclinical_Quantitative_MRI_phantom_T1_T2_ADC_for_High-Field_Systems\" >CaliberMRI Announced Release of a Preclinical Quantitative MRI phantom (T1, T2, ADC) for High-Field Systems&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-bechtel-medical-mrp-calibermri\/#i-Lumen_i-SIGHT_Feasibility_Study_Results_Presented_at_CTS_Retina_2026\" >i-Lumen i-SIGHT Feasibility Study Results Presented at CTS Retina 2026&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-bechtel-medical-mrp-calibermri\/#Arga_Medtech_Completed_Enrollment_of_Paroxysmal_AF_Cohort_in_the_COHERENT-AF_Pivotal_IDE_Study\" >Arg\u00e1 Medtech Completed Enrollment of Paroxysmal AF Cohort in the COHERENT-AF Pivotal IDE Study&nbsp;<\/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-bechtel-medical-received-fda-clearance-for-wound-vox-the-first-510-k-cleared-combined-negative-pressure-and-topical-oxygen-system-nbsp\"><span class=\"ez-toc-section\" id=\"Bechtel_Medical_Received_FDA_Clearance_for_Wound_VOX%E2%84%A2_the_First_510k-Cleared_Combined_Negative_Pressure_and_Topical_Oxygen_System\"><\/span><strong>Bechtel Medical Received FDA Clearance for Wound VOX\u2122, the First 510(k)-Cleared Combined Negative Pressure and Topical Oxygen System&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 10 November 2026, Bechtel Medical received FDA 510(k) clearance for its Wound VOX system, an advanced wound care device that integrated negative pressure wound therapy with topical oxygen therapy. The system featured three treatment modes, including continuous negative pressure therapy, intermittent negative pressure therapy, and intermittent negative pressure therapy combined with supplemental oxygen delivery. The integrated platform was developed to simplify wound treatment by eliminating the need for healthcare professionals to operate separate devices for delivering these therapies. The technology addressed the management of complex and hard-to-heal wounds by combining fluid removal, wound contraction support, and localized oxygen delivery. The company also highlighted independent clinical research that had demonstrated potential improvements in wound healing outcomes with combined negative pressure and topical oxygen therapies compared with negative pressure therapy alone. Bechtel Medical planned a limited commercial release of the device in December 2026.<\/p>\n\n\n\n<p><em>&#8220;Treating hard-to-heal wounds with both negative pressure and concentrated oxygen has historically required clinicians to manage separate systems, adding complexity to an already challenging clinical problem,&#8221; said John Gvodas, Founder and CEO of Bechtel Medical. &#8220;We designed Wound VOX\u2122 to integrate these two therapeutic technologies into a single platform, to simplify the delivery of advanced wound care while addressing some of the operational and economic barriers that have historically limited access to these therapies.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/negative-pressure-wound-therapy-systems-market\"><strong>Negative Pressure Wound Therapy System Market Report<\/strong><\/a>,\u201d the negative pressure wound therapy systems market size is estimated at <strong>USD 3.70 billion<\/strong> in 2025 and is projected to reach <strong>USD 5.79 billion<\/strong> by 2034. Growth is anchored in the rising burden of chronic and surgical wounds, the escalating prevalence of diabetes, and the rapid expansion of single-use and closed-incision negative pressure wound therapy. The global Negative Pressure Wound Therapy Systems market is growing at a <strong>CAGR of 5.1%<\/strong> during the forecast period from 2026 to 2034. Negative pressure wound therapy (NPWT) is an advanced wound care modality that applies controlled sub-atmospheric pressure to a wound through a sealed dressing connected to a vacuum pump, promoting healing by removing exudate and infectious material, reducing edema, increasing blood flow, and drawing wound edges together. A complete NPWT system comprises a therapy unit, a specialized foam or gauze filler and sealing drape, and a canister or absorbent dressing to collect fluid. The category spans conventional, powered NPWT devices used for complex and larger wounds, often with instillation capability, and single-use, disposable, and portable NPWT devices designed for smaller wounds, closed surgical incisions, and ambulatory or home use. NPWT is used across chronic wounds such as diabetic, pressure, and venous ulcers, as well as surgical, traumatic, and burn wounds, in hospitals, specialty and ambulatory clinics, and home settings. Over the past decade, the field has advanced from bulky hospital units toward portable, single-use, closed-incision, and instillation-capable systems, establishing NPWT as a central technology in the management of complex and hard-to-heal wounds worldwide.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mrp-announced-the-launch-of-vydence-zye-ultra-an-advanced-multi-platform-laser-system-designed-to-expand-treatment-possibilities-for-aesthetic-practices-nbsp\"><span class=\"ez-toc-section\" id=\"MRP_Announced_the_Launch_of_VYDENCE_ZYE_Ultra_an_Advanced_Multi-Platform_Laser_System_Designed_to_Expand_Treatment_Possibilities_for_Aesthetic_Practices\"><\/span><strong>MRP Announced the Launch of VYDENCE ZYE Ultra, an Advanced Multi-Platform Laser System Designed to Expand Treatment Possibilities for Aesthetic Practices&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 10 November 2026, Powered by MRP launched the VYDENCE ZYE Ultra, an advanced multi-platform laser system developed to expand treatment capabilities for medical aesthetic practices. The system combined the functionalities of the existing ZYE ALX and ZYE YAG platforms and incorporated dual-wavelength technology with an integrated HandPico feature. It utilized dual-blend technology to deliver two wavelengths in a single pulse, with adjustable proportions and an expanded spot size range of 3\u201324 mm. The platform supported multiple aesthetic applications, including laser hair removal, tattoo removal, pigmentation correction, vascular treatments, photofacials, and skin texture improvement and tightening. Additionally, its expandable architecture accommodated up to six handpieces and multiple laser fibers, allowing aesthetic clinics to broaden their treatment offerings as their requirements evolved. The launch strengthened VYDENCE&#8217;s aesthetic laser portfolio and provided healthcare practitioners with a versatile system for performing multiple laser-based procedures.<\/p>\n\n\n\n<p><em>&#8220;Having spent over a decade in aesthetics, much of it in private practice working with a wide range of laser and energy-based devices, I know how valuable versatility and performance are to a practice,&#8221; said Mary Mitchell, VYDENCE Product Director USA. &#8220;I haven&#8217;t seen many platforms bring together this level of technology in one system. The combination of dual-wavelength capabilities, integrated HandPico, and expandable handpiece options makes ZYE Ultra incredibly exciting. I&#8217;m proud to bring this technology to the U.S. market and can&#8217;t wait for providers to experience it.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/aesthetic-laser-market\"><strong>Aesthetic Lasers Market Report<\/strong><\/a>,\u201d the aesthetic lasers market was valued at <strong>USD 2.63 billion<\/strong> in 2023, growing at a <strong>CAGR of 9.86%<\/strong> during the forecast period from 2024 to 2030 to reach <strong>USD 5.07 billion<\/strong> by 2030. The demand for aesthetic lasers is being driven primarily by the rising number of aesthetic procedures worldwide, growing awareness and preference for cosmetic surgeries, and the latest technological advancements in product offerings. These factors are expected to significantly boost the market from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-calibermri-announced-release-of-a-preclinical-quantitative-mri-phantom-t1-t2-adc-for-high-field-systems-nbsp\"><span class=\"ez-toc-section\" id=\"CaliberMRI_Announced_Release_of_a_Preclinical_Quantitative_MRI_phantom_T1_T2_ADC_for_High-Field_Systems\"><\/span><strong>CaliberMRI Announced Release of a Preclinical Quantitative MRI phantom (T1, T2, ADC) for High-Field Systems&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 10 November 2026, CaliberMRI introduced its Model 340 quantitative MRI phantom for high-field preclinical MRI scanners. The newly launched device featured a 59 mm diameter design, NIST-traceable T1, T2, and apparent diffusion coefficient (ADC) calibration solutions, and a resolution coupon containing hole patterns ranging from 0.4 mm to 1.2 mm. It also incorporated the company&#8217;s patented MR-readable liquid crystal thermometer. The phantom enabled researchers and imaging facilities to compare quantitative MRI measurements across different magnetic field strengths, including 4.7T, 7T, and 9.4T systems. The product launch expanded CaliberMRI&#8217;s existing phantom portfolio and supported improvements in MRI data accuracy, standardization, harmonization, and reproducibility, particularly in preclinical research applications.<\/p>\n\n\n\n<p><em>&#8220;We are excited to support the field with our preclinical phantom and provide an opportunity for sites to compare across field strengths &#8211; particularly in smaller coils and at 4.7T, 7T, and 9.4T,&#8221; says William Hollander, CEO of CaliberMRI. &#8220;We are seeing increasing interest from a broad variety of customers and collaborators implementing qMRI on preclinical scanners and on scanners with smaller bore sizes,&#8221; Hollander added.&nbsp; This phantom, which complements CaliberMRI&#8217;s standard phantom line, provides another opportunity to improve data quality, standardization, harmonization, and reproducibility.&nbsp;&nbsp;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/magnetic-resonance-imaging-devices-market\"><strong>Magnetic Resonance Imaging Market Report<\/strong><\/a>\u201d, the magnetic resonance imaging devices market was valued at <strong>USD 8,207.06 million<\/strong> in 2024, growing at a <strong>CAGR of 6.54%<\/strong> during the forecast period from 2025 to 2032 to reach <strong>USD 13,553.33 million<\/strong> by 2032. The rising prevalence of various chronic disorders, such as cardiovascular diseases, cancer, and neurological conditions, is fueling the demand for precise diagnostic tools like MRI, which offers superior imaging capabilities for soft tissues and organs. Additionally, the increasing awareness and the emphasis on early diagnosis of chronic disease are encouraging patients and healthcare providers to adopt MRI for timely intervention. Furthermore, technological advancements play a crucial role in boosting the MRI market, with innovations such as high-field and open MRI systems, functional MRI (fMRI), and faster scan times improving the accuracy, comfort, and efficiency of the imaging process. Collectively, these factors are expected to expand the demand for magnetic resonance imaging devices globally during the forecast period from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-i-lumen-i-sight-feasibility-study-results-presented-at-cts-retina-2026-nbsp\"><span class=\"ez-toc-section\" id=\"i-Lumen_i-SIGHT_Feasibility_Study_Results_Presented_at_CTS_Retina_2026\"><\/span><strong>i-Lumen i-SIGHT Feasibility Study Results Presented at CTS Retina 2026&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 10 November 2026, i-Lumen Scientific presented the feasibility study results of its i-SIGHT clinical investigation at the 2026 Clinical Trials at the Summit Retina meeting. The multicenter, randomized, sham-controlled study evaluated the safety and potential effectiveness of the company&#8217;s investigational i-Lumen AMD System in 30 patients with intermediate to advanced dry age-related macular degeneration across 10 clinical centers in the United States. The device delivered non-invasive, low-level microcurrent stimulation through the eyelid to influence retinal electrical signaling and support photoreceptor function.<\/p>\n\n\n\n<p>The study demonstrated a mean improvement of 9.62 ETDRS letters in visual acuity in the actively treated eyes at Month 3. More than 50% of treated participants achieved an improvement of at least 10 letters in best-corrected visual acuity at one or more follow-up visits between Months 2 and 12. Exploratory imaging analyses also showed improvements in retinal structural biomarkers, while retinal electrophysiology findings indicated positive changes in photoreceptor response. No unexpected device-related adverse events were reported, and adverse event rates remained comparable between the active treatment and sham groups.<\/p>\n\n\n\n<p>Following these findings, i-Lumen Scientific advanced its clinical development program by initiating the larger pivotal i-SIGHT2 study, which was enrolling participants in the United States and the United Kingdom.<\/p>\n\n\n\n<p><em>&#8220;These findings from a feasibility study suggest that retinal bioelectric stimulation may influence visual function in patients with intermediate to advanced dry AMD,&#8221; said Dr. Bakri. &#8220;While the study was not designed to establish definitive efficacy, the signals observed in visual acuity, retinal electrophysiology, and imaging biomarkers support further evaluation in larger controlled clinical trials.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/ophthalmic-devices-market\"><strong>Ophthalmic Devices Market Report<\/strong><\/a>\u201d, the ophthalmic devices market is estimated at <strong>USD 34.50 billion<\/strong> in 2025 and is projected to reach <strong>USD 54.80 billion<\/strong> by 2034. Growth is anchored in the rising global prevalence of cataract, glaucoma, and retinal disorders, the accelerating myopia epidemic, an aging population, and continuous technological advancement in surgical, diagnostic, and lens-based eye-care solutions. Ophthalmic devices encompass the specialized medical instruments and implants used to diagnose, monitor, and treat disorders of the eye and visual system. Because ocular conditions such as cataract, glaucoma, retinopathies, age-related macular degeneration, and refractive error affect a growing share of the aging and screen-exposed global population, hospitals, specialty eye clinics, and ambulatory surgical centers rely on an expanding toolkit of surgical devices, diagnostic and monitoring systems, and corrective lenses to deliver precise, minimally invasive eye care.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-arga-medtech-completed-enrollment-of-paroxysmal-af-cohort-in-the-coherent-af-pivotal-ide-study-nbsp\"><span class=\"ez-toc-section\" id=\"Arga_Medtech_Completed_Enrollment_of_Paroxysmal_AF_Cohort_in_the_COHERENT-AF_Pivotal_IDE_Study\"><\/span><strong>Arg\u00e1 Medtech Completed Enrollment of Paroxysmal AF Cohort in the COHERENT-AF Pivotal IDE Study&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 11 November 2026, Arg\u00e1 Medtech completed enrollment of 150 participants across 27 clinical sites in the United States and Europe for the paroxysmal atrial fibrillation cohort of its pivotal COHERENT-AF IDE study. The clinical investigation evaluated the safety and effectiveness of the company&#8217;s Coherent Sine Burst Electroporation Platform, which utilized sine wave-based pulsed field ablation technology for treating drug-refractory atrial fibrillation. The study also included a persistent atrial fibrillation cohort, whose enrollment was ongoing at the time. The completion of the first cohort marked an important clinical development milestone and supported the company&#8217;s progress toward future FDA and CE Mark regulatory submissions.<\/p>\n\n\n\n<p><em>&#8220;Completing enrollment in the paroxysmal AF cohort is an important milestone for COHERENT-AF,&#8221; said Emile Daoud, MD, Director of Electrophysiology Research, Hatton Research Institute at Bethesda North Hospital, Cincinnati, Ohio, and the leading enroller in COHERENT-AF. &#8220;In our procedures, the CSE Platform has consistently delivered pulmonary vein isolation with a streamlined, single-catheter workflow, and the ability to address the pulmonary veins, posterior wall, and cavo-tricuspid isthmus without exchanging catheters has been a meaningful advantage in our lab. We look forward to the completion of the persistent AF cohort and the 12-month effectiveness results.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/ablation-devices-market\"><strong>Ablation Devices Market Report<\/strong><\/a>,\u201d the global ablation devices market size is expected to increase from <strong>USD 8,090.31 million<\/strong> in 2025 to<strong> USD 15,347.69 million<\/strong> by 2034, reflecting strong and sustained growth. The global ablation devices market is growing at a <strong>CAGR of 8.38%<\/strong> during the forecast period from 2026 to 2034. The market for ablation device solutions is being primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular diseases, and increasing technological advancements globally.<\/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":36458,"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":[19675,23183,19331,2753,17021,19056,19459,19765],"industry":[17226],"therapeutic_areas":[17242,17244],"class_list":["post-36457","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-ablation-devices","tag-aesthetic-lasers","tag-magnetic-resonance-imaging-devices","tag-medical-device","tag-medical-devices-market","tag-negative-pressure-wound-therapy-systems","tag-ophthalmic-devices","tag-shoulder-replacement-devices","industry-medical-devices","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-ophthalmology"],"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 | Bechtel Medical, MRP, CaliberMRI<\/title>\n<meta name=\"description\" content=\"FX Shoulder Solutions\u2019 Humelock Reversed Shoulder System; Bechtel Medical\u2019s Wound VOX; MRP\u2019s VYDENCE ZYE Ultra\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-bechtel-medical-mrp-calibermri\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News | Bechtel Medical, MRP, CaliberMRI\" \/>\n<meta property=\"og:description\" content=\"FX Shoulder Solutions\u2019 Humelock Reversed Shoulder System; Bechtel Medical\u2019s Wound VOX; MRP\u2019s VYDENCE ZYE Ultra\" 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