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.