Izotropic Corporation’s Clinical Study Timeline for IzoView Breast CT Imaging System
Izotropic Corporation, a medical device company specializing in imaging-based products for accurate breast cancer screening, diagnoses, and treatment, has announced a detailed timeline for its clinical study to secure FDA approval for the IzoView Breast CT Imaging System. This innovative device, which utilizes contrast-enhancement for breast cancer screening in addition to digital breast tomosynthesis (DBT), is specifically designed for patients with dense breast tissue. The company’s strategic approach to this clinical study is expected to significantly reduce the time to PMA (Pre-Market Approval) submission.
7 Phases and Milestones
The clinical study for IzoView is segmented into seven distinct phases, each with significant milestones:
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Prepare IzoView
This phase includes manufacturing, quality assurance, and regulatory preparations for the IzoView device.
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Site Setup
In this phase, the Company will select and prepare three U.S.-based clinical sites to begin data collection. This early data collection will also kickstart the European CE Mark Application process.
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Clinical Study
The clinical study will be conducted at these three sites, with data collection and analysis taking place. This phase will demonstrate the safety and efficacy of the IzoView system.
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Reader Study
This phase focuses on reader training and evaluation, ensuring that radiologists can accurately interpret the data produced by the IzoView system.
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Modular Submissions
During this phase, the Company will submit data modules to the FDA for review. This modular submission design is expected to reduce the time to PMA application by approximately six months.
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PMA Application
The PMA application will be submitted to the FDA based on the data collected during the clinical study and reader study phases. Upon acceptance, the Company will enter into the review process.
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Approval and Sales
Upon FDA approval, Izotropic will begin commercializing the IzoView Breast CT Imaging System.
Impact on Patients and the Medical Community
The expedited clinical study timeline for IzoView has the potential to significantly benefit patients with dense breast tissue, as they will gain access to a more accurate and effective breast cancer screening solution at a faster rate. The modular submission design also allows the medical community to begin using the device in clinical practice sooner, ultimately improving patient outcomes and overall breast cancer detection rates.
Impact on the World
The successful development and approval of the IzoView Breast CT Imaging System will contribute to the global fight against breast cancer. By providing a more accurate and effective screening solution for patients with dense breast tissue, this technology will lead to earlier diagnoses and better treatment outcomes. Moreover, the commercialization of IzoView could potentially influence the development of similar imaging technologies in other fields, driving innovation and advancements in medical diagnostics.
Conclusion
Izotropic Corporation’s strategic approach to the clinical study of its innovative IzoView Breast CT Imaging System demonstrates a commitment to delivering a more accurate and effective breast cancer screening solution for patients with dense breast tissue. With a well-planned timeline, a modular submission design, and a focus on early data collection, the Company is poised to reduce the time to PMA submission and approval. This milestone achievement not only benefits patients and the medical community but also sets the stage for future advancements in medical imaging technologies.
