The US Food and Drug Administration (FDA) has granted a 510(k) approval to Translational Sciences' OncoTrac medical imaging software.
OncoTrac is designed to report precise measurements of treatment response of breast, colorectal, lung, lymphoma and prostate tumors.
The reports can be exported and stored in both picture and archive communications systems (PACS) system and in an electronic medical record (EMR).
OncoTrac enterprise software uses Recist1.0, Recist 1.1, and WHO, Choi criteria standards to assess tumor response.
Translational Sciences CEO Howard Pinsky said with OncoTrac, formal response assessment methods used in clinical trials can be efficiently implemented in routine radiological cancer evaluations in support of patient management.
"Subject assessment data are integrated into existing research workflows, thereby providing capabilities comparable to those performed at core imaging laboratories in support of drug applications," Pinsky said.