“Buzz on the Street” Show: Izotropic Corporation (OTC: IZOZF) (CSE: IZO) Begins FDA Approval Process | Financial Buzz

“Buzz on the Street” Show: Izotropic Corporation (OTC: IZOZF) (CSE: IZO) Begins FDA Approval Process

FinancialBuzz.com’s latest Buzz on the StreetShow: Featuring Our Corporate News Recap on “Izotropic Begins FDA Approval Process”

Izotropic Corporation (OTC: IZOZF) (CSE: IZO) is pleased to announce it has engaged company advisor and FDA Consultant, Anita Nosratieh Ph.D., to develop and manage the Company’s application for FDA medical device approval of its dedicated Breast CT Imaging System.  The first stage towards FDA approval is focused on developing a detailed pre-submission strategy and application, which will be managed by Nosratieh. Her extensive experience includes a position as a lead reviewer at the FDA in the approval process of breast cancer screening and diagnostic devices. The pre-submission meeting provides the opportunity to open a dialogue and obtain FDA feedback prior to the actual submission for medical device approval, resulting in a smoother and more efficient approval process which may expedite patient access to breast CT. Tasks associated with the application include finalizing product and indication for use statements, device labelling terms, and clinical and validation study designs to verify future breast CT marketing claims.

Izotropic Corporation and its wholly owned U.S. operating subsidiary, Izotropic Imaging Corp. have been established to commercialize the next generation of breast imaging technology for early diagnosis of breast cancer. The Izotropic Breast CT Imaging System produces high resolution breast images in 3D. A single 10 second breast CT scan per breast, without requiring painful breast compression, provides radiologists with fully 3D viewing of the scanned breast. Mammography scanning requires compression of the breast between 2 imaging plates, resulting in 2D images.

Among the plethora of segments within the medical devices industry, the medical imaging technology segment is one of the most vibrant. It includes various technologies such as x-ray scan, MRI, CT-scan and others that are used to diagnose diseases and help physicians decide on a course of treatment. Comparable to the medical devices industry, imaging technology growth is heavily dependent on technological advancements, the growing investments made by governments of emerging countries and on the growth of the geriatric population. A recent example of how technology helps transform the sector is the integration of Artificial Intelligence (AI). In fact, just earlier this year, the U.S. Food and Drug Administration (FDA) authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient’s heart that are of acceptable diagnostic quality. Additionally, the global medical imaging market is expected to generate around USD 48.6 Billion by 2025 and at a CAGR of around 5.2% between 2019 and 2025 according to Zion Market Research. 

A major portion of the medical imaging market is cancer imaging systems. Data by BIS Research projects that the global cancer imaging systems is expected to reach USD 11 Billion by 2025. According to the research, the cancer imaging market focuses on major cancer indications (breast cancer, lung cancer, colorectal cancer and prostate cancer, among others) and various imaging modalities (mammography, MRI and positron emission tomography, among others). Cancer imaging systems are crucial tools for potential early cancer detection and diagnostics. The application segment of this market comprises of oncology indications such as breast, lung, colorectal, prostate, liver and other cancers. The breast cancer acquired the highest market value. However, lung cancer is growing at the highest CAGR 5.4%. The reason for such strong market share is attributed to the rising incidence rate of breast cancer among women all over the world.

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