{"id":12146,"date":"2021-05-04T19:18:39","date_gmt":"2021-05-04T13:48:39","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=12146"},"modified":"2021-07-24T12:58:22","modified_gmt":"2021-07-24T07:28:22","slug":"medtech-industry-and-fda-approvals","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-industry-and-fda-approvals","title":{"rendered":"MedTech Industry Roars Back as FDA Approvals Soar"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 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-6a1cf85cccca3\" 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-6a1cf85cccca3\"  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-industry-and-fda-approvals\/#Zimmer_Biomet_Receives_FDA_Approval_for_its_Rosa_System\" >Zimmer Biomet Receives FDA Approval for its Rosa System<\/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-industry-and-fda-approvals\/#LivaNova_Receives_FDA_Clearance_for_its_B-Capta_System_for_the_S5_Heart-Lung_Machine_HLM\" >LivaNova Receives FDA Clearance for its B-Capta System for the S5 Heart-Lung Machine (HLM)<\/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-industry-and-fda-approvals\/#Jolly_Good_and_Teijin_Pharma_Ties_Up_to_Develop_VR_Digital_Therapeutics_for_Depression\" >Jolly Good and Teijin Pharma Ties Up to Develop VR Digital Therapeutics for Depression<\/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-industry-and-fda-approvals\/#BENEV_Launches_Sylfirm_X_Ultimate_Edition_in_the_US\" >BENEV Launches Sylfirm X Ultimate Edition in the U.S.<\/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-industry-and-fda-approvals\/#Phoenix_Cardiac_Receives_CE_mark_for_Mitral_Regurgitation_Device\" >Phoenix Cardiac Receives CE mark for Mitral Regurgitation Device<\/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-industry-and-fda-approvals\/#FDA_Green-Light_to_Lumenis_for_its_IPL_Device_to_manage_Dry_Eye_Disease\" >FDA Green-Light to Lumenis for its IPL Device to manage Dry Eye Disease<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-industry-and-fda-approvals\/#FDA_Approval_to_Medtronic_for_Testing_Implantable_Tibial_Neuromodulation_Therapy_for_Bladder_Incontinence\" >FDA Approval to Medtronic for Testing Implantable Tibial Neuromodulation Therapy for Bladder Incontinence<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-zimmer-biomet-receives-fda-approval-for-its-rosa-system\"><span class=\"ez-toc-section\" id=\"Zimmer_Biomet_Receives_FDA_Approval_for_its_Rosa_System\"><\/span><strong>Zimmer Biomet Receives FDA Approval for its Rosa System<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 20 April 2021, Zimmer Biomet <\/strong>received<strong> FDA 510(k) clearance <\/strong>for its<strong> Rosa Partial Knee system <\/strong>for robotically-assisted partial knee replacement surgeries. This is the new edition to Zimmer Biomet&#8217;s Rosa Robotics platform, which comprises the Rosa Knee system for total knee replacement surgery and Rosa One for neurosurgical and spine procedures.<\/p>\n\n\n\n<p>This system is compatible with Zimmer Biomet&#8217;s Persona Partial Knee. It has 2D and 3D X-Atlas imaging technology with real-time, intraoperative data collection on soft tissue and bone anatomy to increase bone cut accuracy and range of motion gap analysis.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-livanova-receives-fda-clearance-for-its-b-capta-system-for-the-s5-heart-lung-machine-hlm\"><span class=\"ez-toc-section\" id=\"LivaNova_Receives_FDA_Clearance_for_its_B-Capta_System_for_the_S5_Heart-Lung_Machine_HLM\"><\/span><strong>LivaNova Receives FDA Clearance for its B-Capta System for the S5 Heart-Lung Machine (HLM)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 20 April 2021, <\/strong>London-based LivaNova&#8217;s <strong>B-Capta<\/strong>, a novel, in-line, blood-gas monitoring system, received FDA clearance 510(k), to be integrated into the <strong>S5 HLM<\/strong> to effortlessly and accurately monitor the arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures.<\/p>\n\n\n\n<p>LivaNova announced that the <strong>B-Capta<\/strong> received <strong>CE mark approval in Europe<\/strong> in May 2020 and completed a limited commercial release in Europe. The device will now be available globally.<\/p>\n\n\n\n<p>B-Capta system uses sensing technology to provide error-free and continuous measurements to allow the physicians to react to parameter changes quickly. Its interface aligns parameters to those of the hospital&#8217;s laboratory blood gas analyzers, reduces the set-up time, and includes accurate oxygen partial pressure measurements.<\/p>\n\n\n\n<p>The company also announced the FDA 510(k) clearance for the <strong>S5 PRO HLM<\/strong>, an upgraded version of the heart-lung machine and which features B-Capta as a primary component alongside a new level sensor and improved software plus a new alarm system.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-jolly-good-and-teijin-pharma-ties-up-to-develop-vr-digital-therapeutics-for-depression\"><span class=\"ez-toc-section\" id=\"Jolly_Good_and_Teijin_Pharma_Ties_Up_to_Develop_VR_Digital_Therapeutics_for_Depression\"><\/span><strong>Jolly Good and Teijin Pharma Ties Up to Develop VR Digital Therapeutics for Depression<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 23 April 2021, Teijin Pharma Limited<\/strong> entered into a partnership with <strong>Jolly Good Inc.<\/strong> to develop a safe and effective <strong>cognitive-behavioural therapy virtual reality (CBT-VR) system <\/strong>for <strong>anti-depression therapy<\/strong>. The companies will jointly conduct clinical trials and seek regulatory approval in Japan.<\/p>\n\n\n\n<p>The partnership will utilize Jolly Good&#8217;s VR technology and Teijin Pharma&#8217;s expertise in knowledge and strategic skills. The companies have also agreed to support healthcare workers as well as improve the quality of life of patients. This partnership is one of many steps Pharma\/Biotech companies are taking to advance DTx in improving the <a href=\"https:\/\/www.delveinsight.com\/blog\/mental-health-disease-causes-types-risk-factors-and-treatment-options\/?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">mental health<\/a> of patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-benev-launches-sylfirm-x-ultimate-edition-in-the-u-s\"><span class=\"ez-toc-section\" id=\"BENEV_Launches_Sylfirm_X_Ultimate_Edition_in_the_US\"><\/span><strong>BENEV Launches Sylfirm X Ultimate Edition in the U.S. <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 26 April 2021, BENEV Company Inc.,<\/strong> an FDA-registered manufacturer, launched a novel RF micro-needling device, <strong>Sylfirm X<\/strong>, in the United States as the <strong>exclusive distributor<\/strong>. Sylfirm X is the world&#8217;s first and only FDA registered pulsed wave and continuous wave radiofrequency device and has added a new feature of 300-micron depth.<\/p>\n\n\n\n<p><strong>Syl\ufb01rm X Ultimate Edition<\/strong> is manufactured by <strong>Viol Co., Ltd<\/strong> (a Gyeonggi-do, South Korean-based company) and will be distributed by BENEV Company in the U.S. Syl\ufb01rm X claims eight di\ufb00erent continuous and pulse wave bipolar RF delivery modes and uses bipolar non-insulated microneedle RF electrodes to uniformly treat the entire skin layer, maximizing treatment results and offering global skin improvements, mainly redness and vascularity with PW modes; and skin laxity with the CW modes. It is intended for use in dermatologic and general surgical procedures for electrocoagulation and <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemostasis-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">hemostasis<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-phoenix-cardiac-receives-ce-mark-for-mitral-regurgitation-device\"><span class=\"ez-toc-section\" id=\"Phoenix_Cardiac_Receives_CE_mark_for_Mitral_Regurgitation_Device\"><\/span><strong>Phoenix Cardiac Receives CE mark for Mitral Regurgitation Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 26 April 2021, Phoenix Cardiac Devices, Inc.<\/strong> received <strong>CE Mark<\/strong> for its <strong>BACE (Basal Annuloplasty of the Cardia Externally) device<\/strong>, which is a novel modality for the treatment of <strong>Functional Mitral Regurgitation (FMR).<\/strong><\/p>\n\n\n\n<p>BACE is the only surgical device approved with long-term clinical data signifying benefits by addressing the root cause of FMR.<\/p>\n\n\n\n<p>With the CE mark, it is validated that the BACE device is a safe, less invasive, and cost-effective method for the potential treatment of functional mitral regurgitation. According to the company&#8217;s press release, this important milestone will give Phoenix Cardiac a fresh momentum to their efforts to secure a partner for a second clinical study of the BACE device as it pursues a potential indication for heart failure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-green-light-to-lumenis-for-its-ipl-device-to-manage-dry-eye-disease\"><span class=\"ez-toc-section\" id=\"FDA_Green-Light_to_Lumenis_for_its_IPL_Device_to_manage_Dry_Eye_Disease\"><\/span>FDA Green-Light to <strong>Lumenis for its IPL Device to manage Dry Eye Disease <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 29 April 2021, <\/strong>FDA granted <strong>De Novo authorization<\/strong> to <strong>Lumenis Ltd.<\/strong>, the world&#8217;s largest energy-based medical device company for ophthalmic, aesthetic, and surgical applications and the inventor of intense pulsed light (IPL) technology, for its newest <strong>IPL device<\/strong> for improving signs of dry eye disease due to <a href=\"https:\/\/www.delveinsight.com\/report-store\/meibomian-gland-dysfunction-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Meibomian Gland Dysfunction<\/strong><\/a><strong> (MGD).<\/strong> It is the first and only such device to receive FDA approval for improving signs of dry eye disease.<\/p>\n\n\n\n<p>The company has also launched <strong>OptiLight<\/strong>, a bright solution for dry eyes. OptiLight&#x2122; with Lumenis&#8217; patented OPT\u00ae technology is designed for a consistent, precise, and controlled light-based treatment of signs of dry eye disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approval-to-medtronic-for-testing-implantable-tibial-neuromodulation-therapy-for-bladder-incontinence\"><span class=\"ez-toc-section\" id=\"FDA_Approval_to_Medtronic_for_Testing_Implantable_Tibial_Neuromodulation_Therapy_for_Bladder_Incontinence\"><\/span><strong>FDA Approval to <strong>Medtronic<\/strong><\/strong> <strong>for Testing Implantable Tibial Neuromodulation Therapy for Bladder Incontinence<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On<strong> 29 April 2021, Medtronic<\/strong> received approval from the FDA to advance with an <strong>investigational device exemption (IDE) trial<\/strong> to estimate its internally developed implantable <strong>tibial <a href=\"https:\/\/www.delveinsight.com\/report-store\/neuromodulation-devices-market?utm_source=blog&amp;utm_medium=article&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">neuromodulation<\/a> (TNM) device<\/strong>. It is a therapy designed to offer relief from symptoms of <strong>bladder incontinence<\/strong>.<\/p>\n\n\n\n<p>The company will conduct the <strong>TITAN 1 Feasibility Study<\/strong>, a prospective, multicenter feasibility study to characterize the procedure for the implantable TNM device in subjects with bladder incontinence. Around twenty patients from eight sites in the U.S. will receive a device and will be followed for 12 months. Enrollment in the clinical study is expected to begin in May 2021.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zimmer Biomet Receives FDA Approval for its Rosa System On 20 April 2021, Zimmer Biomet received FDA 510(k) clearance for its Rosa Partial Knee system for robotically-assisted partial knee replacement surgeries. This is the new edition to Zimmer Biomet&#8217;s Rosa Robotics platform, which comprises the Rosa Knee system for total knee replacement surgery and Rosa [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":12156,"comment_status":"open","ping_status":"open","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":[2753,16779,16975,16968,16974],"industry":[17226,17225],"therapeutic_areas":[17242,17229,17241,17245,17244,17278],"class_list":["post-12146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-medical-device","tag-medtech","tag-medtech-market","tag-medtronic","tag-zimmer-biomet","industry-medical-devices","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-central-nervous-system","therapeutic_areas-musculoskeletal","therapeutic_areas-neurology","therapeutic_areas-ophthalmology","therapeutic_areas-other-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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