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Microstructure Imaging's MICSI-PET Software Receives FDA Clearance to Enhance Neurological PET Imaging Using MRI

Microstructure Imaging's software platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The platform is designed to enhance neurological positron emission tomography (PET) images using structural magnetic resonance imaging (MRI). The software, called MICSI-PET, can denoise and super-resolve PET images using MRI guidance while preserving quantitative PET information. It supports PET exams for amyloid, Tau, and FDG (fluorodeoxyglucose), and can provide automated Centiloid measurements for amyloid imaging and CenTauR measurements for Tau imaging....

2026-09-18

Norroy Bioscience's 68Ga-NYM096 Receives FDA Breakthrough Therapy and Fast Track Designations

China-based Norroy Bioscience announced on August 19 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations to its radiopharmaceutical imaging agent 68Ga-NYM096. The agent is a PET imaging tracer targeting carbonic anhydrase IX (CAIX), intended for imaging clear cell renal cell carcinoma (ccRCC). According to the company, 68Ga-NYM096 is being developed as a non-invasive PET imaging tool to characterize renal masses detected by CT or MRI and to help distinguish clear cell renal cell carcinoma from other non-ccRCC renal lesions. Clear cell renal cell carcinoma is the most common subtype of renal cell carcinoma...

2026-08-21

FDA Approves Tauklarify, a Tau PET Imaging Agent for Alzheimer's Disease

The U.S. Food and Drug Administration has approved Tauklarify, a new brain imaging agent for the evaluation of Alzheimer's disease. The drug, also known as MK-6240, is a radioactive diagnostic agent for positron emission tomography (PET) in adults, primarily indicated for adults with cognitive impairment who require physician assessment of abnormal tau protein accumulation in the brain. The twisted, insoluble fibrous deposits formed by tau protein are believed to be associated with neurodegenerative diseases such as Alzheimer's disease. The developer, Lantheus, stated that the safety of Tauklarify was evaluated in two clinical trials involving more than 1,700 subjects. Adverse reactions...

2026-08-16

Japanese research team uses PET imaging to find tau protein pathology may be involved in onset of hallucinations and delusions in middle-aged and elderly

A research team comprising the National Institutes for Quantum Science and Technology (QST), Keio University, Kyoto University, Tokyo University of Science, and other institutions recently announced that researchers used PET imaging to observe tau protein pathology in the living brains of middle-aged and elderly psychiatric patients, and believe that such pathology may be related to psychiatric symptoms such as hallucinations and delusions that first appear after age 40. Proportion of positive tau PET and amyloid PET results Middle-aged and elderly psychosis generally refers to diseases in which psychiatric symptoms such as hallucinations and delusions first appear after age 40. Previous epidemiological studies and postmortem brain tissue studies have suggested that such symptoms may be related to neurodegenerative changes associated with dementia, but due to limited techniques for precise visualization and quantification of abnormal proteins in living brains, relevant evidence has long been insufficient.

2026-08-10

Institute of Radiation Medicine, Chinese Academy of Medical Sciences Hosts Academic Seminar on PSMA-Targeted Radiopharmaceuticals

On August 3, the Institute of Radiation Medicine, Chinese Academy of Medical Sciences held an academic seminar, inviting Professor Lin Guoxian from the BC Cancer Agency in Vancouver, Canada, to deliver a lecture titled "Development of Prostate-Specific Membrane Antigen-Targeted Radiopharmaceuticals for the Diagnosis and Treatment of Prostate Cancer." The seminar was held in a hybrid format, with some researchers and graduate students from the institute attending in person. Professor Lin Guoxian has long been engaged in the development of targeted radiopharmaceuticals for cancer diagnosis and therapy, having led or contributed to the publication of over 135 peer-reviewed journal articles, filed more than 30 patent applications related to radiopharmaceuticals, and completed clinical translation of 7 self-developed radiopharmaceuticals applied in...

2026-08-07

Japanese PET Study Suggests Late-Onset Psychosis May Be Linked to Neurodegenerative Pathology

A nuclear medicine imaging study conducted by a Japanese research team has shown that many adults who experience psychotic symptoms such as hallucinations and delusions for the first time after age 40 have abnormal protein deposits in the brain associated with Alzheimer's disease and other neurodegenerative disorders. The study included 37 patients with late-onset psychosis and 47 age-matched healthy controls. The researchers used the amyloid PET tracer ^11C-PiB and the tau protein PET tracer ^18F-florzolotau to assess the accumulation of β-amyloid and tau proteins in the participants' brains. The results showed that among patients with late-onset psychosis, β-amyloid positivity...

2026-08-06

Curium and Lantheus Reach Definitive Merger Agreement to Build a Global Integrated Radiopharmaceutical Theranostics Platform

On August 3, global radiopharmaceutical company Curium announced that it has entered into a definitive merger agreement with Lantheus Holdings, Inc. Under the agreement, Curium US Holdings LLC will merge with Lantheus through its wholly owned subsidiary, with a total consideration of up to $114.50 per share and a total transaction value of approximately $8 billion. Under the terms of the agreement, Curium US will acquire all outstanding shares of Lantheus at $102.50 per share in cash upon closing of the transaction. In addition, Lantheus shareholders will receive non-transferable contingent value rights, entitling them to up to $12.00 per share in additional cash payments if certain commercial milestones for Lantheus-related products are achieved by 2030...

2026-08-04

Curium Advances Second Cyclotron Investment Plan in Romania to Expand PET Imaging Supply

On July 30, Curium announced that it is advancing its second cyclotron investment plan in Romania to expand access to advanced nuclear medicine services locally and further strengthen healthcare infrastructure. According to the introduction, after completing assessments of market opportunities, technical requirements, and regional infrastructure, Curium has identified the Cluj-Napoca region as the preferred site for the project and selected a preferred local partner. Preparatory work is currently underway to support the project's progression to the next phase. This expansion plan aims to increase relevant production capacity, enhance PET imaging equipment and service supply capabilities, improve patient access to advanced diagnostic procedures, and support the...

2026-07-30