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Perimeter Medical Imaging AI Announces Alignment with FDA on Key Elements of Ongoing Clinical Trial Evaluating AI-enabled B-Series OCT Medical Imaging Technology
Perimeter Medical Imaging AI Announces Alignment with FDA on Key Elements of Ongoing Clinical Tri...
About this update from Perimeter Medical Imaging Ai Inc
[{"type":"text","content":"\n \n \n \n Perimeter Medical Imaging AI Announces Alignment with FDA on Key Elements of Ongoing Clinical Trial Evaluating AI-enabled B-Series OCT Medical Imaging Technology\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n \n \n \n \n Enhanced Artificial Intelligence Software and Interim Analysis Integrated into Current Study\n \n \n \n \n \n \n TORONTO\n \n and\n \n DALLAS\n \n \n ,\n \n \n Sept. 7, 2023\n \n \n /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) (FSE: 4PC) (\"Perimeter\" or the \"Company\") – a commercial-stage medical technology company – today provided an update on the clinical development of its ongoing clinical trial evaluating the use of Perimeter B-Series OCT combined with its proprietary ImgAssist AI software during breast conservation surgery. Based on feedback from the U.S. Food and Drug Administration (\"FDA\"), the Company has reached alignment on key elements of the ongoing clinical trial, including the introduction of an interim analysis, which is expected in the second quarter of 2024.\n \n \n \n Adrian Mendes\n \n , Perimeter's Chief Executive Officer stated, \"This positive interaction with the FDA marks an important milestone in our clinical development program. As a first step, we received regulatory approval to implement our substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol, and we have now aligned on other key elements in order to chart a clear path forward for the development of our B-Series OCT with ImgAssist AI.\"\n \n \n Mr. Mendes continued, \"Importantly, we will have a planned interim analysis in the trial, which will provide us with an early read-out of results based on the use of the newest algorithm. If key endpoints are met at the time of the interim analysis,\n \n we may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance\n \n . Alternatively, the interim analysis could support continuing the trial to b...