Radiostics offers end-to-end support for AI companies developing imaging solutions, including regulatory strategy development, data annotation, multi-reader validation studies, FDA submission preparation, consultation and collaboration, AI algorithm and software development, biostatistics support, and QMS establishment. We help navigate the complexities of bringing AI-driven imaging technologies to market.

We assist with AI solutions across multiple imaging modalities, including X-ray, CT, MRI, ultrasound, PET, nuclear imaging, mammography, angiography, fluoroscopy, and digital pathology. Our expertise spans a variety of clinical applications, from disease detection and diagnosis to treatment planning and workflow optimization.

We provide a customized regulatory pathway based on your AI solution, whether it requires a 510(k), De Novo, or PMA submission. Our team helps with:

• Preparing technical documentation and validation reports

• Conducting multi-reader validation studies

• Navigating interactions with the FDA

Radiostics identifies expert clinicians for each project, ensuring that our multi-reader validation studies are conducted by top specialists with deep domain expertise. We often utilize pre-processors, field-specific technicians or image annotators, to expedite expert image annotations, establishing high-quality reference standards for FDA validation. We identify and curate multi-institutional validation datasets from our Academic Partners. Our structured approach streamlines study design, execution, and statistical analysis, enabling us to complete FDA validation studies faster than industry norms. This efficiency reduces costs and accelerates time to market for AI imaging solutions.

Radiostics streamlines the FDA approval pathway by leveraging deep regulatory expertise, optimizing study design, and expediting data processing. A 510(k) validation study and application can often be completed in just 4 to 6 months.

Our approach includes:

• Proactively addressing regulatory requirements to avoid common pitfalls

• Designing and executing efficient validation studies

• Reducing time for data curation, expert annotation, and submission preparation

• Rapidly conducting multi-reader validation studies with top clinical experts

• Providing robust biostatistical support to strengthen FDA applications

By optimizing each stage of the process, we help Industry Partners achieve FDA clearance faster, reducing costs and accelerating time to market.

Pricing is determined by project scope, dataset size, and regulatory complexity. Radiostics structures its fees to cover service costs only, including data curation, validation studies, and regulatory support. As a virtual company with no brick-and-mortar expenses, we maximize efficiency while minimizing overhead. Our focus is on accelerating FDA clearance with a streamlined process, ultimately saving companies money by reducing time to market and ensuring regulatory success. Contact us for a customized quote based on your AI project needs.

If you’re developing an AI imaging solution and need expert guidance, reach out to us! Contact Us today to discuss how we can help accelerate your FDA clearance and bring your AI product to market efficiently.