{"id":46265,"date":"2022-07-18T14:02:04","date_gmt":"2022-07-18T12:02:04","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/radialis-pet-imager-receives-fda-clearance\/"},"modified":"2022-07-18T14:02:04","modified_gmt":"2022-07-18T12:02:04","slug":"radialis-pet-imager-receives-fda-clearance","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/radialis-pet-imager-receives-fda-clearance\/","title":{"rendered":"Radialis PET Imager Receives FDA Clearance"},"content":{"rendered":"<div>\n<p>\n<b><i>Bringing Medical Insight into Focus<\/i><\/b>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220718005044\/en\/1514295\/5\/Radialis_PET_Imager_High_Res.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220718005044\/en\/1514295\/21\/Radialis_PET_Imager_High_Res.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20220718005044\/en\/1514276\/5\/Radialis_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220718005044\/en\/1514276\/21\/Radialis_Logo.jpg\"><\/a><\/p>\n<p>THUNDER BAY, Ontario&#8211;(BUSINESS WIRE)&#8211;Radialis Inc. announces it has received FDA clearance to market the Radialis PET Imager, an advanced organ-targeted positron emission tomography (PET) system, in the United States.\n<\/p>\n<p>\nThe heightened sensitivity of the Radialis PET Imager to radiotracer enables the system to produce functional images with high spatial resolution, expanding the insight available from molecular imaging. Able to visualize any positron-emitting radiotracer, the system is particularly promising for imaging novel radiotracers targeting biomarkers in a specific organ. The small system footprint allows it to be incorporated into existing nuclear medicine facilities to complement traditional PET\/CT.\n<\/p>\n<p>\n<i>Cleared Indications for Use:<\/i>\n<\/p>\n<p>\nThe Radialis PET Imager is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.\n<\/p>\n<p>\n<i>Cleared Device Description:<\/i>\n<\/p>\n<p>\nThe Radialis PET Imager is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Imager is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Imager is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient\u2019s body part with high efficiency.\n<\/p>\n<p>\n<b>About Radialis<\/b>\n<\/p>\n<p>\nRadialis delivers best-in-class organ-targeted positron emission tomography (PET) medical imaging systems. Radialis\u2019 proprietary technology is based on discoveries made at Lakehead University and its advanced manufacturing facility is in Thunder Bay, Ontario. More information is available at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.radialis.com&amp;esheet=52781309&amp;newsitemid=20220718005044&amp;lan=en-US&amp;anchor=www.radialis.com&amp;index=1&amp;md5=9b714349de017d7d0cb12ed4901f25ba\" rel=\"nofollow noopener\" shape=\"rect\">www.radialis.com<\/a>.\n<\/p>\n<p>\n<b>Forward-Looking Statement<\/b>\n<\/p>\n<p>\nStatements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Although we believe that any forward-looking statements contained in this press release are reasonable, there can be no assurance that any such forward-looking statements will prove to be accurate. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media:<\/b><br \/>Michael Waterston<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x69;&#x6e;&#x66;&#x6f;&#x40;&#x72;&#x61;&#100;&#105;&#97;&#108;&#105;&#115;&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#105;&#x6e;&#102;&#x6f;&#64;&#x72;a&#100;&#x69;&#97;&#x6c;i&#x73;&#46;&#99;&#x6f;&#109;<\/a><br \/>1-800-601-3177 ext. 2\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Bringing Medical Insight into Focus THUNDER BAY, Ontario&#8211;(BUSINESS WIRE)&#8211;Radialis Inc. announces it has received FDA clearance to market the Radialis PET Imager, an advanced organ-targeted positron emission tomography (PET) system, in the United States. The heightened sensitivity of the Radialis PET Imager to radiotracer enables the system to produce functional images with high spatial resolution, &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/radialis-pet-imager-receives-fda-clearance\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-46265","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Radialis PET Imager Receives FDA Clearance - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/radialis-pet-imager-receives-fda-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Radialis PET Imager Receives FDA Clearance - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Bringing Medical Insight into Focus THUNDER BAY, Ontario&#8211;(BUSINESS WIRE)&#8211;Radialis Inc. announces it has received FDA clearance to market the Radialis PET Imager, an advanced organ-targeted positron emission tomography (PET) system, in the United States. The heightened sensitivity of the Radialis PET Imager to radiotracer enables the system to produce functional images with high spatial resolution, ... 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