Using Popper’s Inside Out Diagnostic, we helped an international developer of clinical and diagnostic technology develop and implement a regulatory strategy that resulted in a 510(k) de novo submission to the FDA.

Assessment of Business Needs

Popper and Company was engaged by LBT Innovations, a global developer of clinical and diagnostic technologies, to develop a regulatory strategy. LBT Innovations wanted to secure FDA approval for their artificial intelligence (AI) imaging technology and Popper was engaged to develop and implement the regulatory strategy that resulted in a 510(k) de novo submission to the FDA.

Our Approach

  • Provided project management and support for the implementation of the US study.

  • Identified and evaluated best fit for a US laboratory capable of participating in the 510(k) trial.

  • Worked with client on protocol development and essential trial documents.

  • Interfaced with client and laboratory on trial processes.

  • Developed documents in compliance with Institutional Review Board and FDA.

  • Managed clinical laboratory study to meet projected metrics and timelines.

  • Assessed and maintained device functions.

  • Trained clinical research staff on study objectives and implementation of protocol.

Synthesis and Outcome

Popper and Company successfully completed this pivotal study for our client enabling them to proceed with a time-constrained FDA submission process and a fiscally-conserved trial budget. The 12-month clinical trial achieved its target primary endpoints and results of the AI technology matched or exceeded the findings of a panel of experienced microbiologists. In 2016, the FDA approved LBT Innovations’ breakthrough AI imaging and software for use as a medical device.