Izotropic begins FDA approval process for imaging system

• Izotropic (CSE:IZO) has engaged Nita Nosratieh to assist in the US FDA approval process for its Breast CT Imaging System
• As a former lead reviewer at the FDA, Anita will help to develop a detailed pre-submission strategy and application
• The application is expected to be completed in 8 to 10 weeks, after which a pre-submission meeting can be scheduled
• Anita will also assist in presenting the system to the FDA’s Center for Devices and Radiological Health Payor Communication Task Force
• Izotropic (IZO) is up 2.7 per cent and is currently trading at C$0.19 per share, with a market cap of $5.69 million

Izotropic (CSE:IZO) has engaged Nita Nosratieh to assist in the US FDA approval process for its Breast CT Imaging System.

Through its wholly owned US-based operating subsidiary, Izotropic Imaging, the company has developed a breast imaging system capable of generating high-resolution 3D images. 

This is done using a ten-second CT scan, capturing roughly 500 individual images and providing a 3D view to radiologists.

As a former lead reviewer at the US Food and Drug Administration (FDA), specialising in breast cancer screening and diagnostic devices, Anita will assist in developing a detailed submission strategy and application. 

These tasks involve finalising product and usage statements, device labelling terms, and clinical and validation study blueprints to confirm future marketing claims.

This is the first step in establishing a discussion between Izotropic and the FDA and precedes the company’s final submission for medical device approval. 

With Anita’s expertise on side, Izotropic is anticipating a much smoother and more efficient approval process, which could lead to accelerated patient access.

The pre-submission application process is expected to take between 8 and 10 weeks. Once the application is submitted, a back-and-forth discussion will begin, resulting in a formal written response. 

Such responses are usually received within 90 days and allow for the scheduling of the pre-submission meeting.

In addition, Anita will also facilitate strategy and presentation development for the FDA’s Center for Devices and Radiological Health Payor Communication Task Force. This program is aimed at supporting clinical trial designs, as well as gathering necessary evidence to elicit a positive review decision.

Izotropic (IZO) is up 2.7 per cent and is currently trading at C$0.19 per share at 2:48pm EDT.