Clinical Diagnostics Business Acceleration
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.
- 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.