Lantheus Holdings (NSDQ:LNTH) announced today that it received FDA 510(k) clearance for its automated bone scan index (aBSI).
The North Billerica, Mass.-based parent company of Lanthus Medical Imaging, Progenics Pharmaceuticals and Exini Diagnostics said in a news release that the clearance is for the artificial intelligence-enabled aBSI product for use on GE Healthcare’s Xeleris platform.
In October 2019, Lantheus entered into a global software licensing agreement with GE Healthcare for the rights to the standalone aBSI platform, enabled by AI to automate the detection of hotspots in bone that are indicative of metastatic disease and calculate the aBSI.
Under the agreement, GE Healthcare acquired the software license for aBSI for integration into its Xeleris platform, excluding its use in Japan, while Lantheus will receive tiered licensing fees per license sold.
“Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare’s platform,” Lantheus senior VP of corporate development Etienne Montagut said in the release. “As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution. aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions.
“Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology,” Mr. Montagut added.
