EXINI Diagnostic AB receives FDA clearance for cloud aBSI in United States.

The cloud based neural network of aBSI device automatically segments the different anatomical regions of the skeleton followed by detection and classification of lesions in bone scan of prostate cancer patients. The aBSI has been shown to be an objective measure of the quantitative change in disease burden and is a prognostic biomarker in patients with metastatic prostate cancer. 

In August, the Company received 510(k) clearance from the FDA to market their cloud-based version of Automated Bone Scan Index (aBSI) product in the U.S (K191262). A 510(k) filing is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as compared to a legally marketed device that is not subject to a Premarket Approval application.

The clearance of a cloud based software as a medical device is an essential step towards the further development and clearance of the PSMA(PyL) AI product.

“The FDA clearance is a validation of our approach in using AI technology to solve clinically relevant problems in disease management of patients with prostate cancer” said Aseem Anand, Vice President and Site Manager of EXINI Diagnostic AB, Sweden.

As of 2017, aBSI is provided as a secure and compliant web application readily available from a web browser by logging in to, www.bonescanindex.com.  In Europe, the device is CE-marked according to MDD 93/42 EEC, and is available for clinical use in Austria, Denmark, France, Germany, Ireland, Netherlands, Sweden, Switzerland, UK.

EXINI Diagnostics AB

EXINI Diagnostics AB was established in 1999 to commercialize AI methods for automated analysis of diagnostic images developed by a research group at Lund University. As a certified medical device manufacturer, EXINI has developed automated analysis platforms for cardiac, brain and bone scans. The company has always been innovative, developing web-based systems in the early 2000s. EXINIs most widely distributed platform is used to calculate the automated Bone Scan Index, which quantifies the bone tumor burden in patients with metastatic prostate cancer. This platform has been installed at about 1,000 hospitals worldwide. In 2015, EXINI was acquired by Progenics Pharmaceuticals Inc. for developing patient centric AI technologies for PSMA-targeted theranostic agents.