{"id":28392,"date":"2026-06-30T18:30:00","date_gmt":"2026-06-30T16:30:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=3694615ab5bf1a5372b439e57577a2c6"},"modified":"2026-06-30T18:30:00","modified_gmt":"2026-06-30T16:30:00","slug":"reflexion-submits-fda-510k-for-anchor-point-tracking-advancing-the-next-generation-of-scintix-autonomous-radiotherapy","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=28392","title":{"rendered":"RefleXion Submits FDA 510(k) for Anchor Point Tracking, Advancing the Next Generation of SCINTIX Autonomous Radiotherapy"},"content":{"rendered":"<p class=\"bwalignc\">\n<i>Submission builds on the X2 platform\u2019s 20X increase in PET sensitivity to further enhance biologic guidance and expand versatility of SCINTIX therapy<\/i><\/p><p>HAYWARD, Calif.--(BUSINESS WIRE)--<a href=\"https:\/\/twitter.com\/hashtag\/SCINTIX?src=hash\" >#SCINTIX<\/a>--RefleXion Medical, an external beam theranostic oncology company, today announced it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for Anchor Point<span>\u2122<\/span> Tracking, a next-generation tumor tracking technology designed for use with the new <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Freflexion.com%2Fpress-releases%2Ffda-clears-next-generation-reflexion-platform-that-improves-tumor-detection%2F&amp;esheet=54562351&amp;newsitemid=20260630645085&amp;lan=en-US&amp;anchor=RefleXion%26%23174%3B+X2&amp;index=1&amp;md5=64c178fa2a4398f375cbea12811b7847\" rel=\"nofollow\" shape=\"rect\">RefleXion<span>\u00ae<\/span> X2<\/a> platform.<\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841928\/5\/New_X1_photos_straight_on.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841928\/22\/New_X1_photos_straight_on.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841928\/5\/New_X1_photos_straight_on.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841928\/21\/New_X1_photos_straight_on.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841918\/5\/RefleXion_Primary_Logo_500.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841918\/22\/RefleXion_Primary_Logo_500.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841918\/5\/RefleXion_Primary_Logo_500.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260630645085\/en\/2841918\/21\/RefleXion_Primary_Logo_500.jpg\" \/><\/a><p>\n\u201cAnchor Point Tracking represents the next major advancement in autonomous radiotherapy,\u201d said Todd Powell, CEO and president of RefleXion. \u201cThe X2 platform\u2019s 20-fold increase in PET sensitivity enables development of a sophisticated tracking algorithm that underpins SCINTIX therapy with significantly richer biologic data for directing treatment in real time.<\/p><p>\n\u201cWe believe this additional information will permit more precise and more robust treatment delivery, while creating a scalable platform that expands the range of tumors and clinical scenarios SCINTIX therapy can address.\u201d<\/p><p>\nThe X2 platform\u2019s significantly increased positron emission tomography (PET) sensitivity is produced by quadrupling its onboard PET detectors, providing higher-fidelity biologic data that enables powerful autonomous treatment algorithms such as Anchor Point Tracking. By identifying a consistent biologic \u201canchor\u201d within the PET data used to track tumors, the X2 delivers an increased level of precision in treatment delivery. If cleared, Anchor Point Tracking is expected to expand the versatility of SCINTIX therapy by supporting treatment across a broader range of tumor sizes, shapes and motion characteristics.<\/p><p>\nThe submission is supported by extensive system validation and phantom testing. Parallel work conducted by leading academic investigators demonstrated improvements in target tracking, dose conformity, motion management and organ-at-risk sparing enabled by the X2 platform and Anchor Point Tracking. <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fevents.reflexion.com%2Faapm%2Fscientific-evidence%2F&amp;esheet=54562351&amp;newsitemid=20260630645085&amp;lan=en-US&amp;anchor=These+findings&amp;index=2&amp;md5=46241f9002fd10e45caee029b9cbba2b\" rel=\"nofollow\" shape=\"rect\">These findings<\/a> will be presented at the 2026 American Association of Physicists in Medicine (<a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Faapm.confex.com%2Faapm%2F2026am%2Fmeetingapp.cgi&amp;esheet=54562351&amp;newsitemid=20260630645085&amp;lan=en-US&amp;anchor=AAPM&amp;index=3&amp;md5=f0a7392eae098abeb99c18b9b7179866\" rel=\"nofollow\" shape=\"rect\">AAPM<\/a>) Annual Meeting, July 19-22, in Vancouver, B.C.<\/p><p>\nAnchor Point Tracking is currently pending FDA 510(k) review and is not commercially available in the United States.<\/p><p>\n<b>About RefleXion Medical<\/b><\/p><p>\nRefleXion is a privately held external beam theranostic oncology company in Hayward, Calif., commercializing SCINTIX autonomous radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real\u2011time biological beacons to direct external\u2011beam radiotherapy. SCINTIX therapy is FDA\u2011cleared for FDG\u2011guided treatment of primary and metastatic lung and bone tumors. The RefleXion X2 platform is also cleared for conventional image\u2011guided radiotherapy for solid tumors anywhere in the body. For more information, visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.reflexion.com&amp;esheet=54562351&amp;newsitemid=20260630645085&amp;lan=en-US&amp;anchor=www.reflexion.com&amp;index=4&amp;md5=973f143f56cc2db293155ccfa16d559a\" rel=\"nofollow\" shape=\"rect\">www.reflexion.com<\/a>.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n<strong>Media Contact<\/strong><br\/><a  href=\"mailto:contact@reflexion.com\" rel=\"nofollow\" shape=\"rect\">contact@reflexion.com<\/a><br\/>+1-650-239-9070<\/p>","protected":false},"excerpt":{"rendered":"<p>Submission builds on the X2 platform\u2019s 20X increase in PET sensitivity to further enhance biologic guidance and expand versatility of SCINTIX therapyHAYWARD, Calif.&#8211;(BUSINESS WIRE)&#8211;#SCINTIX&#8211;RefleXion Medical, an external beam theranostic oncology c&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-28392","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/28392","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=28392"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/28392\/revisions"}],"predecessor-version":[{"id":28393,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/28392\/revisions\/28393"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=28392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=28392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=28392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}