US-based medical imaging firm Lantheus has secured the US Food and Drug Administration (FDA) 510(k) approval for its artificial intelligence (AI) enabled automated bone scan index (aBSI) product on GE Healthcare’s Xeleris platform.
In October 2019, Lantheus has reached a global software licencing agreement with GE Healthcare for the rights to its aBSI.
The aBSI is an AI-enabled vendor neutral platform that automatically detects hotspots in bone that indicate metastatic disease and calculates aBSI in Technetium-99m bone scintigraphy.
The platform is said to provide a rapid and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer.
According to Lantheus, the recent investigations have also confirmed the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.
GE Healthcare nuclear medicine general manager Erez Levy said: “The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care.
“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.”
GE Healthcare acquires Lantheus’ software licence for aBSI
Under the terms of the agreement, GE Healthcare has acquired the Lantheus’ software licence for aBSI for integration into its Xeleris platform.
Lantheus will receive tiered licencing fees per license sold. However, the agreement excludes the use of aBSI in Japan.
The company has secured the FDA approval for its AI-powered product in 2019.
Lantheus is engaged in development, manufacture and commercialisation of advanced diagnostic and therapeutic products. It is the parent company for Lantheus Medical Imaging, Progenics Pharmaceuticals, and EXINI Diagnostics.
The company offers a range of products, including the echocardiography agent DEFINITY Vial for injectable suspension, TechneLite, a technetium-based generator, AZEDRA for neuroendocrine tumours and RELISTOR for opioid-induced constipation.
Lantheus Holdings corporate development senior vice president 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.
“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.”
