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NEWS

NEXTBIOMEDICAL Enrolls First Patient in RESORB Trial of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots: NEXTBIOMEDICAL has enrolled the first patient in the RESORB trial, evaluating Nexsphere-F vs intra-articular corticosteroid injections for use in GAE in ~126 US pts with painful knee osteoarthritis Nexsphere-F data from 155 pts published in The JVIR showed a 67% average pain reduction at 6mos., while a study published in The OJSM demonstrated safety…
October 14, 2025

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NEWS

Surgical Theater’s SyncAR Spine Platform Secures the US FDA’s 510(k) Clearance for Spine Surgery

Shots: The US FDA has granted 510(k) clearance to SyncAR Spine platform to enhance precision in spine surgery SyncAR Spine, integrated with Medtronic StealthStation, uses AI-driven vertebra segmentation, advanced decompression planning, & segmental fusion to streamline surgical planning & help align preoperative models with intraoperative CT SyncAR Spine also allows surgeons to monitor bone removal…
October 13, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 06, 2025 – Oct 10, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:      AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer  Read More: AstraZeneca and Daiichi Sankyo  AstraZeneca Reports P-III (Bax24) Trial Data on…
October 10, 2025

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NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots: Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mapping vMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardia The system also integrates with lab workflows to deliver rapid, non-invasive,…
October 8, 2025

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NEWS

IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Shots: The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapy ProSense is a minimally invasive cryosurgical tool that uses liquid nitrogen to freeze & destroy tumors in breast, kidney, lung & liver, with similar safety & efficacy observed…
October 6, 2025

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NEWS

Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel

Shots: Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm Suite The chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…
October 6, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer  Read More: Daiichi Sankyo & AstraZeneca  Merck Presents P-III (HYPERION) Trial Data…
October 3, 2025

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NEWS

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots: Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial Assays Panther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…
October 3, 2025

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Abbott
NEWS

Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee

Shots: Abbott has received Health Canada’s approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with chronic limb-threatening ischemia (CLTI) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty, which showed improved patient outcomes, with 48% fewer repeat procedures over the study period. Data was highlighted…
October 1, 2025

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Novocure
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Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC

Shots: The P-III (METIS) trial assessed TTFields therapy + best supportive care (BSC) (n=149) vs BSC (n=149) in 298 adults with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery; median TTFields use was 67% over 16wks. Trial met its 1EP, with a 28% lower risk of intracranial progression, extending median time to 15…
September 30, 2025

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