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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

FDA Grants 510(k) Clearance to Emboliner System for TAVR Procedures

The U.S. Food and Drug Administration (FDA) has approved Emboliner, a cardiac protection system from Emboline, for percutaneous coronary intervention (TAVR) and other cardiac procedures. The device is designed to capture and remove embolic material generated during TAVR, protecting vital organs such as the brain and kidneys. The Emboliner system uses a dual-layer annular filter to cover the brain and systemic arteries, designed to intercept and clear debris generated during TAVR procedures. Unlike other embolic protection devices that only shield selected cerebral vessels, this design allows the central lumen of the TAVR delivery system to pass through the filter, effectively enhancing the scope of protection. The FDA's decision follows a comprehensive clinical evaluation of Embol...

2026-09-17

Curium's Lutetium-177 Injection Approved by FDA for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Radiopharmaceutical company Curium recently announced that its developed lutetium-177 (Lu-177) dotatate injection (trade name: Bexlutry) has received formal approval from the U.S. Food and Drug Administration (FDA). The drug is indicated for the treatment of somatostatin receptor-positive adult gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The specific indication scope includes various neuroendocrine tumors occurring in the adult foregut, midgut, and hindgut. Bexlutry is an advanced radioligand therapy whose mechanism of action lies in its ability to specifically bind to somatostatin receptors highly expressed on the surface of such tumors. Through this precise binding, the drug can deliver...

2026-09-16

FDA Approves Telix's New Brain Tumor Imaging Agent Pixclara

The U.S. Food and Drug Administration (FDA) has approved a new brain tumor imaging agent developed by Australian pharmaceutical company Telix, the company announced on Monday. The product, called Pixclara, is a radioactive diagnostic drug used in combination with positron emission tomography (PET) imaging. Its primary use is to help doctors distinguish between recurrent brain tumors and harmless changes caused by prior treatment. The FDA approval comes after Telix faced an FDA rejection last year due to insufficient evidence. Kevin Richardson, CEO of Telix Precision Medicine, said in a statement: "As the first FDA-approved PET imaging drug for glioma (a type of brain tumor), Pixclara will provide physicians in the United States with more definitive diagnoses and greater confidence in patient treatment planning."

2026-09-15

GE HealthCare's StarGuide GX Digital 4D CZT SPECT/CT Receives FDA 510(k) Clearance in the U.S.

GE HealthCare recently announced that its new digital 4D CZT SPECT/CT system, StarGuide GX, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The system had previously obtained CE marking, and this U.S. clearance marks progress in the clinical adoption of its next-generation molecular imaging technology. Designed for theragnostics and precision medicine needs, StarGuide GX is a comprehensive SPECT/CT system. It supports imaging at multiple energy levels, enables general-purpose SPECT imaging, and is tailored for emerging tracer applications, including investigational α-emitters, aiming to provide imaging support for clinicians and researchers exploring new pathways in diagnosis, treatment planning, and therapeutic response monitoring.

2026-09-09

FDA Grants Breakthrough Therapy Designation to JBS-003 for Guiding De-escalated Radiotherapy in HPV-Positive Oropharyngeal Cancer

On September 1, Juniper Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its hypoxia tracer JBS-003. The product, 18F-Fluoromisonidazole (FMISO), is intended to identify tumor hypoxia and guide de-escalated radiotherapy in patients with HPV-positive oropharyngeal cancer (OPC). JBS-003 is licensed from Memorial Sloan Kettering Cancer Center (MSK). According to information released by the company, the tracer is based on F-MISO PET molecular imaging technology and can visualize specific hypoxic features within tumors. Tumor hypoxia is considered to be associated with radioresistance; by imaging hypoxic regions, clinicians can stratify patients by risk and...

2026-09-02

Cubresa Brain PET Scanner Receives FDA 510(k) Clearance, Integrates with Existing PET/MR Systems

Molecular imaging technology company Cubresa Inc. announced on August 20 that its Cubresa BrainPET™ scanner has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). According to the company, the Cubresa BrainPET™ is a positron emission tomography (PET) device specifically designed for brain imaging and can be integrated into existing Siemens Biograph mMR MR/PET systems. The device enables healthcare institutions to perform simultaneous PET/MR brain imaging on existing MRI infrastructure, capturing molecular and anatomical information without the need to purchase a separate whole-body hybrid imaging system. Cubresa founder and CEO James ...

2026-08-22

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

LG Electronics Launches FDA-Approved 40-Inch Diagnostic Monitor for B2B Medical Imaging Market

LG Electronics announced on August 12 that it has launched a new 40-inch diagnostic monitor, the 40HT513D, targeting the business-to-business (B2B) medical display market. The product has received approval from the U.S. Food and Drug Administration (FDA) and is primarily intended for medical image interpretation. According to the company, the 40HT513D features a curved IPS black panel with a 21:9 aspect ratio and a resolution of 5120×2160, delivering approximately 11 million pixels. LG Electronics stated that this design consolidates image reading tasks that previously required three 3-megapixel monitors into a single screen. Physicians can simultaneously view and compare current and historical images from X-ray, CT scans, and MRI scans on the same display...

2026-08-12

ITM Receives Complete Response Letter from FDA for ¹⁷⁷Lu-edotreotide New Drug Application

Radiopharmaceutical biotechnology company ITM Isotope Technologies Munich SE (ITM) announced on August 10 that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding the New Drug Application (NDA) for its investigational drug ¹⁷⁷Lu-edotreotide (ITM-11). The drug is intended for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

2026-08-11

Grand Pharma's FAP-targeted diagnostic radiopharmaceutical GPN01530-2 receives FDA Fast Track designation

On August 9, 2026, Grand Pharmaceutical issued a voluntary announcement stating that its self-developed global innovative radionuclide drug conjugate GPN01530-2 has recently been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of solid tumors. Previously, the product had already been approved by the FDA to conduct Phase I/II clinical studies for the diagnosis of solid tumors. GPN01530-2 is a small-molecule radionuclide drug conjugate (RDC) targeting fibroblast activation protein (FAP). Data shows that FAP is not expressed or is lowly expressed in normal tissues, but is highly expressed in tumor-associated fibroblasts within the tumor microenvironment of various cancers, and is considered a novel specific target in the field of tumor diagnosis and treatment...

2026-08-10

China's First Homegrown Radiopharmaceutical Receives Dual FDA Breakthrough Therapy and Fast Track Designations

On August 6, Nuoyu Medical announced that the U.S. Food and Drug Administration (FDA) has officially granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to the company's independently developed 68Ga-NYM096. This marks the first product in China's original radiopharmaceutical field to receive FDA Breakthrough Therapy Designation, and the first to receive both FDA Breakthrough Therapy and Fast Track designations simultaneously, creating a milestone breakthrough in the radiopharmaceutical field. 68Ga-NYM096 is a small-molecule diagnostic radiopharmaceutical for renal cancer that specifically binds to CAIX, suitable for positron emission tomography (PET) imaging of suspected or confirmed metastatic clear cell renal cell carcinoma (c...

2026-08-08

US FDA Approves Pluvicto Expanded Indication for Treatment of PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

On July 31, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer. This disease is commonly referred to as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on results from the Phase III PSMAddition trial. The study showed that compared with standard of care alone, namely ARPI combined with androgen deprivation therapy (ADT), Pluvicto plus standard of care reduced the risk of disease progression or death by...

2026-08-03