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HomeFDALantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform

Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare’s Xeleris Platform

November 13, 2020

Lantheus Holdings the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus’ artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.

Lantheus Holdings Sr. Vice President of Corporate Development Etienne Montagut said, “Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare’s platform. 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.” She added, “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.”

In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2

“The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care,” said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. “For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world.”

Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare’s Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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