Advanced medical imaging and analysis enters FDA guidance, accelerates preclinical trials

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The data driving R&D and commercialization decisions in medtech innovation, like histology, can be underpowered and don’t expound the entire product efficacy story. The processing of those images and the associated analysis can be painfully slow and in many cases subject to detrimental observer-based bias and variability – a simple issue of the human eye and brain. Skilled human observers are great at being inconsistently inconsistent.

Need & Solution: Improving objectivity and validation of advanced imaging data

ImageIQMicro CT Valve Leaflets 2 jpg, a Cleveland Clinic Innovations imaging CRO and software company, has translated a manual, subjective, time-consuming process into an automated function using customized software algorithms that produce data that is objective, quantitative and backed by strong validation.

“Instead of looking at a few representative images here and there, microCT can generate data from hundreds and even thousands of image slices, thus providing a more global tissue-level view of each specimen,” says ImageIQ Vice President Brett Hoover. “Combining this with automated quantitative image analysis should produce more powerful data that will enable better decisions and faster translation from preclinical research to clinical trials.

“In some cases, good 3D data allow us to reduce the amount histology that needs to be performed…. and the FDA just recently included microCT in its new preclinical testing draft guidance document. Medtech innovators should seriously consider it in their product development plans.”

[See “General Considerations for Animal Studies for Medical Devices | Draft Guidance for Industry and Food and Drug Administration Staff,” Oct. 14, 2015”]

When preclinical sponsors supplement imaging generated at T3 with quantitative image analysis from ImageIQ, data that previously took months to obtain now arrives almost overnight, and at higher scientific quality.

Results: Advanced medical imaging and analysis saves time and money in preclinical processes

For one T3 preclinical sponsor in orthopaedic medical devices, specimens were already embedded for histology. T3 scanned 30 samples in fewer than four days. ImageIQ then custom built and validated the image processing algorithm and provided the quantitative image analysis. The quality of the imagery and analysis enabled the sponsor to determine they could omit originally planned histology and microscopy, thus saving them several months and tens of thousands of dollars.

Read the entire ImageIQ / T3 case study here. Learn more about T3 Labs’ unparalleled preclinical imaging capabilities here.

To learn more about accelerating preclinical trials through advanced imaging and analysis, contact Evan Goldberg via email: evan.j.goldberg@emoryhealthcare.org