Figure 1. To measure damaged versus un-damaged area in an ablation device, we can simply measure cross-sectional area or perimeter across a digital scanned slide
Medical device development depends on pathology assessment of tissues, both for efficacy studies as well as toxicology. Because there are a limited number of pathologists who specialize in medical devices, the waits and delays can often be long and frustrating, and the evaluations are subjective.
Investors and regulatory agencies demand quantitative data on efficacy and toxicity. We can help you provide it. At Flagship, we utilize whole slide imaging to allow our pathologists to review the slides remotely, resulting in faster turnaround and a completely archivable digital process. In addition, with a whole slide image, we can quickly quantitate lesions or other biological events across an entire tissue section, which previously required hours or days of manual labor.
The quantitation ranges from simple perimeter or cross-sectional measurements (Figure 1), to more advanced histology pattern recognition approaches (Figure 2), which have almost limitless applications.
Some of our medical device applications are found on the links below. If you have other ideas you would like us to try, please contact us.
Fibrous capsule measurement for coated devices
Revascularization measurements in a cardiac patch
Automated quantification of pacemaker lead tissue changes
Measuring plaque in heart tissue
Infarct tissue measurement – presentation at the AHA
Cardiac repair using regenerative medicine and digital pathology
Quantification of biocompatiblity with FACTS
Figure 2. We can also approach this with more advanced techniques, using histology pattern recognition to automatically segregate damaged from undamaged tissue, and provide a very accurate quantitative measurement of damage
