(TheNewswire)
Vancouver, BC - TheNewswire - September 27, 2023 - Izotropic Corporation (“Izotropic” or the “Company”) (CSE:IZO) (OTC:IZOZF) (FSE:1R3), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today it has confirmed a pre-submission meeting date with the U.S. Food and Drug Administration (FDA) scheduled for October 25, 2023.
Further to its news release on September 6, 2023, Izotropic completed a pre-submission application to the FDA to solidify its plans to pursue market clearance for IzoView as a Class II device through a 510(k) pre-market notification submission.
The purpose of the upcoming meeting is to discuss the application, obtain feedback, and confirm next steps. The meeting will take place in Rockville, Maryland, and will be attended by Izotropic’s management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.
The Company will issue a news release in due course after the meeting to report on its progress.
ON BEHALF OF THE BOARD
Mr. Robert Thast, CEO
Cell: 604-220-5031
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