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Case Study: How a Start-Up Developing an Innovative AI-Enabled Imaging Device Achieved FDA Clearance in 24 Months

the situation

The Situation

  • Our client approached EVERSANA seeking regulatory guidance for a novel AI-enabled imaging device. The client understood the technology would be a regulated medical device and wanted to guarantee that it could place the device on market in the United States following the 510(k) regulatory pathway.
  • The client needed to devise a regulatory strategy that provided guardrails for an early-stage company to continue development without introducing features that would compromise the company’s stated regulatory objectives.
the solution

The Solution

  • EVERSANA’s Regulatory Consulting strategists with expertise in radiological imaging, diagnostic devices, and software as a medical device (SaMD) partnered closely with the client’s management team to understand their business goals and establish a regulatory strategy. The EVERSANA team then embedded itself as part of the product team, collaborating on product design and writing necessary documentation that detailed product features and AI algorithm functions, including discussions on input verification, model performance and training and verification datasets. We also assisted the client in developing a cybersecurity plan that included a risk assessment, threat modeling, OTS documentation, and a vulnerability monitoring plan.
  • Once the product design was finalized and documented, we assembled an FDA Q-Submission to ask questions and receive feedback from FDA. Based on responses received during the pre-submission teleconference, EVERSANA’s Regulatory Consulting provided critical advice to our client, including guidance on human factors and clinical validation plans.
  • While the client completed the clinical validation, we drafted the 510(k)-submission using the FDA eSTAR program. Because the documentation created during the development lifecycle was high quality, EVERSANA’s Regulatory Consulting team was able to complete and submit the 510(k) in four months.
the results

The Results

  • FDA review of the 510(k) submission was completed in less than 90 days, clearing the device for the U.S. market. EVERSANA’s Regulatory Consulting team then assisted the client with establishment registration, device listing, and UDI implementation. The client is now actively selling its novel AI-enabled imaging device.