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NEWS

Tempus AI Receives the US FDA’s 510(k) Clearance for Updated Tempus Pixel Cardiac Imaging Platform

Shots: Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps for enhanced cardiac MRI analysis Tempus Pixel delivers advanced viewing & automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional…
September 12, 2025

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NEWS

neurocare Receives the US FDA’s Clearance for Apollo TMS Therapy Devices to Treat Major Depressive Disorder in Adolescents

Shots: neurocare has received US FDA clearance for its Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices to treat major depressive disorder (MDD) in adolescents The Apollo TMS Therapy system is a non-invasive treatment that uses a magnetic coil on the head to stimulate targeted brain pathways, with about 60% of patients achieving remission with TMS…
September 11, 2025

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NEWS

QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Shots: QIAGEN has obtained European CE-IVDR certification for its QIAstat-Dx Meningitis/Encephalitis (ME) Panel to diagnose CNS infections, securing CE-IVDR approval for its entire QIAstat-Dx syndromic testing systems & panels The QIAstat-Dx ME Panel offers CNS infection coverage with 16 clinically relevant targets, incl. cytomegalovirus to meet current clinical needs & exclusive Streptococcus pyogenes detection to…
September 11, 2025

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NEWS

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Shots: Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis Additionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UK GAE aims to reduce knee pain by advancing a small catheter into the…
September 9, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 01, 2025 – Sep 05, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, Animal Health and Biosimilars. Check out our full report below:    Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)  Read More: Merck  AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat…
September 5, 2025

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Roche
NEWS

Roche Reports the European CE Mark Approval of Contivue to Treat Neovascular Age-Related Macular Degeneration

Shots: Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
September 5, 2025

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NEWS

AliveDx Reports the US FDA’s 510(k) Submission for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease; available in IVDR CE-marking countries since Jul 2025 VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM…
September 4, 2025

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