EXINI’s Artificial Intelligence enabled product received FDA clearance on GE Healthcare’s XELERIS platform
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of EXINI’s artificial intelligence enabled automated bone scan index (aBSI) on GE Healthcare’s Xeleris platform. EXINI has entered into a global software licensing agreement with GE Healthcare for the rights to EXINI bone, a vendor neutral stand-alone variant of aBSI that is enabled with artificial intelligence. Under the terms of the non-exclusive agreement EXINI will receive tiered licensing fees per license sold.
Automated Bone Scan Index (aBSI)
The automated Bone Scan Index (aBSI) technology, developed by EXINI Diagnostics AB, gives a fully quantitative assessment of bone scans that incorporates inferred masses of all lesions. 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, and UK. As of October 2019, aBSI is also available for clinical use in the United States with a 510(k) clearance (K191262). aBSI is also available for local installation under the name EXINI bone. As of January 2019, EXINI bone is CE marked according to MDD 93/42 EEC.
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. In 2020, Progenics Pharmaceuticals, Inc. was acquired by Lantheus Holdings, Inc.