{"id":380811,"date":"2020-11-13T08:33:29","date_gmt":"2020-11-13T13:33:29","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=380811"},"modified":"2020-11-13T08:33:29","modified_gmt":"2020-11-13T13:33:29","slug":"lantheus-holdings-announces-fda-clearance-for-ai-enabled-automated-bone-scan-index-absi-in-prostate-cancer-on-ge-healthcares-xeleris-platform","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lantheus-holdings-announces-fda-clearance-for-ai-enabled-automated-bone-scan-index-absi-in-prostate-cancer-on-ge-healthcares-xeleris-platform\/","title":{"rendered":"Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform"},"content":{"rendered":"

<\/p>\n

Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform<\/b><\/p>\n

NORTH BILLERICA, Mass.–(BUSINESS WIRE<\/a>)–
\nLantheus Holdings, Inc. (the \u201cCompany\u201d) (NASDAQ: LNTH), 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\u2019 artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare\u2019s Xeleris platform.\n<\/p>\n

\n\u201cLantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare\u2019s 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,\u201d said Etienne Montagut, Sr. Vice President of Corporate Development. \u201caBSI 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,\u201d Mr. Montagut added.\n<\/p>\n

\nIn 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<\/sup><\/p>\n

\n\u201cThe pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care,\u201d said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. \u201cFor 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.\u201d\n<\/p>\n

\nUnder the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare\u2019s Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.\n<\/p>\n

About aBSI<\/b><\/p>\n

\nThe aBSI product is vendor neutral stand-alone software as a medical device which calculates the automated bone scan index in Technetium-99m bone scintigraphy. aBSI received FDA clearance in 2019 (K191262). The product is enabled with a neural network that has been trained to automate the detection of hotspots and calculate the aBSI value.\n<\/p>\n

About Lantheus Holdings, Inc. <\/b><\/p>\n

\nLantheus Holdings, Inc. is 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY\u00ae<\/sup> Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite\u00ae<\/sup> (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA\u00ae<\/sup> for the treatment of certain rare neuroendocrine tumors; and RELISTOR\u00ae<\/sup> for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com<\/a>.\n<\/p>\n

About GE Healthcare<\/b><\/p>\n

\nGE Healthcare is the $16.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.\n<\/p>\n

Safe Harbor for Forward-Looking and Cautionary Statements<\/b><\/p>\n

\nThis press release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201cconfident,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cwill\u201d and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the market receptivity to aBSI and to GEHC\u2019s XELERIS platform; (ii) the intellectual property protection of aBSI; and (iii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).\n<\/p>\n

\n_________________
\n
1<\/sup> Armstrong AJ, Anand A, Edenbrandt L,et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951.
\n
2<\/sup> Ali A, Hoyle AP, Parker CC, et al. The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE\u2019s \u201cM1|RT Comparison\u201d. European Urology. 2020 Aug; 3(4): 412-419\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201113005122\/en\/<\/a><\/span><\/p>\n

\nMark Kinarney
\n
Senior Director, Investor Relations
\n
978-671-8842
\n
ir@lantheus.com<\/a><\/p>\n

\nMelissa Downs
\n
Director, Corporate Communications
\n
646-975-2533
\n
media@lantheus.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America Massachusetts<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research Technology Medical Devices FDA Software Biotechnology Pharmaceutical Health Science Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
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Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform NORTH BILLERICA, Mass.–(BUSINESS WIRE)– Lantheus Holdings, Inc. (the \u201cCompany\u201d) (NASDAQ: LNTH), 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\u2019 artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare\u2019s Xeleris platform. \u201cLantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare\u2019s platform. As a leading multinational medical … <\/p>\n

Continue reading “Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-380811","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nLantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lantheus-holdings-announces-fda-clearance-for-ai-enabled-automated-bone-scan-index-absi-in-prostate-cancer-on-ge-healthcares-xeleris-platform\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Lantheus Holdings Announces FDA Clearance for AI-Enabled Automated Bone Scan Index (aBSI) in Prostate Cancer on GE Healthcare\u2019s Xeleris Platform NORTH BILLERICA, Mass.–(BUSINESS WIRE)– Lantheus Holdings, Inc. (the \u201cCompany\u201d) (NASDAQ: LNTH), 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\u2019 artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare\u2019s Xeleris platform. \u201cLantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare\u2019s platform. 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(the \u201cCompany\u201d) (NASDAQ: LNTH), 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\u2019 artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare\u2019s Xeleris platform. \u201cLantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare\u2019s platform. 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