Translational Sciences Corporation, a firm specializing in the licensing and commercialization of medical software, has received 510(k) approval from the FDA for its OncoTrac medical imaging software. OncoTrac is designed for quantitatively tracking the treatment response of tumors in accordance with a number of accepted assessment standards.
The software provides oncology practitioners and researchers with a validated means to report accurate measurements of solid and metastatic tumors for both routine clinical practice and clinical trials.
According to the company website, OncoTrac offers the following benefits for end users:
- Highly intuitive user interface
- Configurable workflow environment
- Track and measure multiple lesions over time
- Automatically generates structured reports
- Improves study subject management
- Encourages routine tumor quantification desired by many oncologists
- Allows earlier modification of ineffective therapies
- Conformance checker decreases errors
- Facilitates oncology research
- Flexible evaluation criteria
- Developed to meet FDA research and clinical standards
- GMP, QSR, GCP and Part 11 Electronic Records standards compliant
OncoTrac was originally developed by Mint Medical, a medical imaging company based in Germany. It is currently in use in a number of clinics in Europe under the Mint Lesion brand name. Translational Sciences Corporation has exclusively licensed the rights to commercialize the product in North America.
Product page: OncoTrac…
Press release: Translational Sciences Corporation Receives FDA 510(k) Clearance for Commercialization of OncoTrac™ in the United States
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