Health Logic Interactive Inc, is pleased to announce its continued progress towards an 510(k) pre-submission meeting with the United States Food and Drug Administration (the “FDA“) for its diagnostic screening device MATLOC 1 that is anticipated to occur in September 2021 (the “Pre-Submission Meeting”). An FDA 510(k) pre-submission meeting is a method for a company like Health Logic to receive feedback and guidance from the FDA on its potential FDA 510(k) submission plan.
The Company has engaged Reveles Clinical Service, a specialty Contract Research Organization (Southlake, TX), to provide regulatory strategy and clinical trial management, to assist the Company with the necessary documentation and clinical plan in preparation for the Pre-Submission Meeting.
The Company intends to obtain the following guidance from the FDA at the Pre-Submission Meeting:
“We are excited to be making this progress towards an FDA 510(k) pre-submission meeting and believe this will be an important step in our progression toward FDA 510(K) approval. We expect that the results of the Pre-Submission Meeting should help de-risk the pathway and provide the clarity necessary for a successful 510(k) application,” stated David Barthel, CEO of Health Logic Interactive.
About the Company
Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient’s smartphones and digital continued care platforms. The Company plans to use its patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient’s smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at: www.healthlogicinteractive.com
Further information regarding Health Logic Interactive Inc. and its disclosure documents are available on SEDAR at www.sedar.com.