{"id":18301,"date":"2022-08-04T17:57:41","date_gmt":"2022-08-04T12:27:41","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=18301"},"modified":"2024-09-18T13:20:52","modified_gmt":"2024-09-18T07:50:52","slug":"medtech-news-for-irhythm-respiri","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-irhythm-respiri","title":{"rendered":"FDA Clearance to iRhythm\u2019s ZEUS System; Respiri Introduces the Wheezo Device &amp; App; CONMED to Acquire Biorez for $ 85 Million; FDA Clearance to Ambu\u2019s Single-Use Bronchoscope; FDA 510(k) Clearance to Glaukos\u2019s iStent infinite"},"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-69f658c155b56\" 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-69f658c155b56\"  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-irhythm-respiri\/#iRhythm_receives_FDA_clearance_for_ZEUS_System_for_Zio_watch\" >iRhythm receives FDA clearance for ZEUS System for Zio watch<\/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-irhythm-respiri\/#Respiri_Introduces_the_Wheezo_Device_and_App_to_the_US_Market\" >Respiri Introduces the Wheezo Device and App to the US Market<\/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-irhythm-respiri\/#CONMED_to_Acquire_Medical_Device_Start-up_Biorez_for_USD_85_Million\" >CONMED to Acquire Medical Device Start-up Biorez for USD 85 Million<\/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-irhythm-respiri\/#Ambu_Announces_FDA_Clearance_of_Fifth-Generation_Single-Use_Bronchoscope\" >Ambu Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope<\/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-irhythm-respiri\/#Glaukos_Announces_FDA_510k_Clearance_of_iStent_infinite%C2%AE\" >Glaukos Announces FDA 510(k) Clearance of iStent infinite\u00ae<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-irhythm-receives-fda-clearance-for-zeus-system-for-zio-watch\"><span class=\"ez-toc-section\" id=\"iRhythm_receives_FDA_clearance_for_ZEUS_System_for_Zio_watch\"><\/span><strong>iRhythm receives FDA clearance for ZEUS System for Zio watch<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>iRhythm Technologies<\/strong>, a leading digital healthcare solutions firm focused on advancing cardiac care, announced that it received <strong>FDA 510(k)<\/strong> clearance for the <strong>ZEUS (Zio ECG Utilization Software) System<\/strong> for the <strong>Zio Watch<\/strong>. It is produced in partnership with <strong>Verily<\/strong>, which is an <strong>Alphabet precision health company<\/strong>; the<strong> ZEUS System <\/strong>combines deep learning algorithms with a proven and well-established <a href=\"https:\/\/www.delveinsight.com\/report-store\/cardiac-arrythmia-market\"><strong>cardiac arrhythmia<\/strong><\/a> service. The ZEUS System is the <strong>AI algorithm <\/strong>and solution component of the Zio Watch, which is:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A sensor-based wearable for non-invasive,<\/li><li>Clinical grade, and<\/li><li>helps in long-term continuous monitoring for atrial fibrillation<\/li><\/ul>\n\n\n\n<p>Verily received FDA 510(k) clearance for the Zio Watch. The Zio Watch integrated with the ZEUS System is a unified, prescription-based solution that addresses clinician workflows, care pathways, and the patient experience. The cleared Zio Watch is a wearable solution that not only detects <a href=\"https:\/\/www.delveinsight.com\/report-store\/atrial-fibrillation-market\"><strong>atrial fibrillation<\/strong><\/a> but also characterizes the amount of atrial fibrillation over time, thus aiding a clinician in diagnosis. The Zio Watch uses continuous photoplethysmography and an artificial intelligence-based algorithm used to detect atrial fibrillation and calculate its burden estimate. A preliminary report is then shared with the patient&#8217;s clinician for review, potentially leading to a diagnosis and clinical intervention afterward.<\/p>\n\n\n\n<p>iRhythm has what is believed to be the world&#8217;s largest repository of labeled <strong>ECG data<\/strong>, which it leveraged to develop its proprietary <strong>PPG algorithm<\/strong>.&nbsp;<\/p>\n\n\n\n<p>The <strong>Zio Watch<\/strong> will complement <strong>Zio monitors<\/strong> by adding a modality with longer wear times for patients requiring long-term monitoring to detect, characterize and manage atrial fibrillation. The Zio Watch is a cost-effective, non-invasive monitoring solution and will fully integrate with the Zio service. iRhythm is planning to introduce the ZEUS System for a limited market evaluation in 2023.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Respiri_Introduces_the_Wheezo_Device_and_App_to_the_US_Market\"><\/span><strong>Respiri Introduces the Wheezo Device and App to the US Market<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Respiri<\/strong>, an Australian digital health company, has made Michigan Children&#8217;s Hospital the first US customer for its <strong>wheezo device app<\/strong> and <strong>healthcare monitoring platform<\/strong>. The Software as a Service (SaaS) platform detects wheeze, a common sign of asthma, chronic obstructive pulmonary disease, and other respiratory diseases, and provides an objective assessment of airway blockage. The wheezo system, which was approved by the FDA last year, has now been connected with Access Telehealth&#8217;s remote patient monitoring platform Remotli at Michigan, and the first US patients are anticipated to utilize it in the coming weeks.<\/p>\n\n\n\n<p>The system will be reimbursable and will target children with asthma to reduce exacerbations and hospitalizations, improve patient outcomes, and save healthcare costs. Access is currently collaborating on integration with <strong>Michigan&#8217;s electronic medical record (EMR) system<\/strong>. According to the company, monitoring and maintaining abnormal breathing patterns in respiratory disease patients is currently insufficient in the United States.<\/p>\n\n\n\n<p>Patients use wheezo to record 30 seconds of normal breathing with the device placed on the trachea, which <strong>Respiri <\/strong>claims are sufficient to offer an objective assessment of wheeze that can assist diagnose diseases and guide treatment. The mobile app aids patients in controlling their <a href=\"https:\/\/www.delveinsight.com\/report-store\/asthma-diagnostic-devices-market\">asthma<\/a> by tracking symptoms, triggers, medication use, and environmental factors such as pollen and pollution levels.<\/p>\n\n\n\n<p>As per the DelveInsight analysis in the \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-obstructive-pulmonary-disease-treatment-devices-market\"><strong>Chronic Obstructive Pulmonary Disease Treatment Devices Market<\/strong><\/a><strong> Report,\u201d<\/strong> the global chronic obstructive pulmonary disease (COPD) treatment devices market is expected to increase at a <strong>CAGR of 6.37%<\/strong> during the forecasted period (2022-2027). The rise in demand for chronic obstructive pulmonary disease treatment devices is mostly due to increased exposure to air pollution, airborne particles, chemicals &amp; fumes, secondhand smoke, industrial chemicals, and dust, all of which contribute to the global rise in COPD prevalence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CONMED_to_Acquire_Medical_Device_Start-up_Biorez_for_USD_85_Million\"><\/span><strong>CONMED to Acquire Medical Device Start-up Biorez for USD 85 Million<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CONMED company on Monday announced a definitive agreement to acquire privately held <strong>Biorez, Inc. (Biorez)<\/strong> for <strong>USD 85 million<\/strong> in cash at closing, subject to adjustment, and up to an additional <strong>USD 165 million<\/strong> in growth-based earnout payments over a four-year period. The company&#8217;s existing credit facility will most likely finance the acquisition, and the deal is expected to be completed in early August 2022.<\/p>\n\n\n\n<p><strong>Biorez <\/strong>is a New Haven, Connecticut-based medical device start-up focused on advancing soft tissue healing with its proprietary <strong>BioBrace\u00ae Implant technology.<\/strong> The BioBrace implant is a novel bioinductive scaffold designed to fortify soft tissue where it is weak and facilitate healing. The FDA has approved <strong>BioBrace\u00ae<\/strong> in a variety of product sizes.<\/p>\n\n\n\n<p><em>\u201cThe addition of Biorez and its BioBrace\u00ae platform represents an important step forward for our sports medicine portfolio,\u201d<\/em> commented <strong>Curt R. Hartman, CONMED\u2019s Chair of the Board, President, and Chief Executive Officer.<\/strong> <em>\u201cBioBrace\u00ae fits seamlessly into our existing suite of products, and we are excited to advance the next generation of healing in sports medicine. BioBrace\u00ae represents the type of high-growth, high-margin platform that drives our long-term vision for CONMED.\u201d<\/em><\/p>\n\n\n\n<p><strong>Kevin Rocco, Chief Executive Officer of Biorez<\/strong>, added, <em>\u201cI am proud of the Biorez team for developing an innovative healing solution that provides a new treatment option for surgeons and patients. We are thrilled to join CONMED to accelerate the growth of our technology on a global scale.\u201d<\/em><\/p>\n\n\n\n<p><strong>CONMED <\/strong>anticipated that this transaction would bring about <strong>USD 1 million<\/strong> to its recently disclosed full-year 2022 revenue estimate. CONMED expected that the purchase will be dilutive to adjusted cash earnings per share by <strong>USD 0.10 to USD 0.15<\/strong> in 2022 and 2023 but accretive afterward. As a result, CONMED now anticipates full-year 2022 adjusted diluted net profits per share in the <strong>USD 3.25 to USD 3.45<\/strong> range.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ambu_Announces_FDA_Clearance_of_Fifth-Generation_Single-Use_Bronchoscope\"><\/span><strong>Ambu Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the latest <a href=\"https:\/\/www.delveinsight.com\/medical-devices\"><strong>regulatory updates in the MedTech market<\/strong><\/a>, the Columbia-based medical device maker,<strong> Ambu Inc.,<\/strong> has announced that it has received <strong>510(k) regulatory clearance<\/strong> from the <strong>U.S. Food and Drug Administration (FDA) <\/strong>for its bronchoscope, <strong>Ambu\u00ae aScopeTM 5 Broncho<\/strong>. It is a single-use sterile bronchoscope.<\/p>\n\n\n\n<p>Earlier, in May 2022, Ambu announced clearance from the <strong>European regulatory authority <\/strong>for its <strong>bronchoscopes<\/strong>. With the approval from US and EU authorities, Ambu is now looking forward to the commercialization of the aScope 5 Broncho and the full high definition Ambu\u00ae aBoxTM 2 processing unit in Europe and the USA. The aScope 5 Broncho family has advanced imaging and design features. It is equipped with a new high-resolution camera chip, which, in combination with the aBox 2, delivers a superior image.<\/p>\n\n\n\n<p>Bronchoscopy is a considerably complex medical procedure requiring high-performance image quality and handling scopes. Bronchoscope Market is a competitive domain with several prominent MedTech companies operating in the segment. With the clearance for its aScope 5 Broncho, Ambu now leads the entry of <a href=\"https:\/\/www.delveinsight.com\/report-store\/endoscopes-market\"><strong>single-use endoscopes in the bronchoscopy suite<\/strong><\/a>.<\/p>\n\n\n\n<p>As per DelvInsight\u2019s latest assessment report on the \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/bronchoscope-market\"><strong>Global Bronchoscopes Market<\/strong><\/a>,\u201d some of the key factors such as growing prevalence of respiratory diseases such as tuberculosis, the rising prevalence of lung cancers, the growth in the number of cases related to chronic obstructive pulmonary diseases, and increasing product development activities in the domain, will significantly drive the market growth in the coming years. Furthermore, the Bronchoscopes Market is expected to grow at a<strong> CAGR of 7.46%<\/strong> during the forecast period (2022 to 2027) and is expected to reach <strong>USD 29.38 billion <\/strong>by 2027.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Glaukos_Announces_FDA_510k_Clearance_of_iStent_infinite%C2%AE\"><\/span><strong>Glaukos Announces FDA 510(k) Clearance of iStent infinite\u00ae<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The ophthalmic medical technology and pharmaceutical company &#8211; <strong>Glaukos Corporation <\/strong>pivots around <a href=\"https:\/\/www.delveinsight.com\/report-store\/glaucoma-pipeline-insight\"><strong>novel therapies for glaucoma treatment<\/strong><\/a><strong>,<\/strong> as well as<strong> corneal disorders <\/strong>and <strong>retinal diseases treatment<\/strong>. It announced that it got 510(k) clearance from the U.S. FDA for their novel <strong>iStent infinite\u00ae Trabecular Micro-Bypass System<\/strong> in a standalone procedure for elevated <strong>intraocular pressure (IOP) reduction <\/strong>in <a href=\"https:\/\/www.delveinsight.com\/report-store\/primary-open-angle-glaucoma-poag-epidemiology-forecast\"><strong>patients with primary open-angle glaucoma<\/strong><\/a> uncontrolled by prior medical and surgical therapy.&nbsp;<\/p>\n\n\n\n<p>The iStent infinite contains three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately six clock hours around<strong> Schlemm\u2019s canal,<\/strong> the eye\u2019s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite has a similar mechanism of action to the company\u2019s <strong>two-stent iStent inject\u00ae W Trabecular Micro-Bypass System<\/strong>, which is approved by the FDA for the reduction of IOP in adult <a href=\"https:\/\/www.delveinsight.com\/report-store\/primary-open-angle-glaucoma-poag-market\"><strong>mild-to-moderate primary open-angle glaucoma patients<\/strong><\/a> undergoing concomitant <a href=\"https:\/\/www.delveinsight.com\/report-store\/cataract-pipeline-insight\"><strong>cataract surgery.<\/strong><\/a><\/p>\n\n\n\n<p>\u201cThis FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared <a href=\"https:\/\/www.delveinsight.com\/report-store\/active-implantable-medical-devices-market\"><strong>micro-invasive implantable device<\/strong><\/a> indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,\u201d said <strong>Thomas Burns,<\/strong> chairman and chief executive officer. \u201cSupported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24\/7 IOP control for their patients in need. We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent infinite to the U.S.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>iRhythm receives FDA clearance for ZEUS System for Zio watch iRhythm Technologies, a leading digital healthcare solutions firm focused on advancing cardiac care, announced that it received FDA 510(k) clearance for the ZEUS (Zio ECG Utilization Software) System for the Zio Watch. It is produced in partnership with Verily, which is an Alphabet precision health [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":18303,"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":[97,19608,19607,19511,19510,2828,2753,18799,420,19006],"industry":[17226],"therapeutic_areas":[17242,17244,17243],"class_list":["post-18301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-atrial-fibrillation","tag-bronchoscopes","tag-bronchoscopes-market","tag-endoscopes","tag-endoscopes-market","tag-glaucoma","tag-medical-device","tag-medtech-news","tag-news","tag-open-angle-glaucoma","industry-medical-devices","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-ophthalmology","therapeutic_areas-respiratory-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MedTech News and Updates | iRhythm, Respiri, CONMED, Ambu, Glaukos<\/title>\n<meta name=\"description\" content=\"iRhythm\u2019s ZEUS System; Respiri&#039;s Wheezo Device &amp; App; CONMED to Acquire Biorez; Ambu\u2019s Single-Use Bronchoscope; Glaukos\u2019s iStent infinite\" \/>\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-irhythm-respiri\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News and Updates | iRhythm, Respiri, CONMED, Ambu, Glaukos\" \/>\n<meta property=\"og:description\" content=\"iRhythm\u2019s ZEUS System; Respiri&#039;s Wheezo Device &amp; App; CONMED to Acquire 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