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NEWS

Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots: The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatment AVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearance The AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney…
October 29, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 21, 2025 – Oct 24, 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 and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer  Read More: Daiichi Sankyo and Merck  Gilead…
October 24, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 13, 2025 – Oct 17, 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:  Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas  Read More: Arcus Biosciences  HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…
October 17, 2025

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Roche
NEWS

Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease

Shots: The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence population Elecsys pTau217 is an in-vitro diagnostic…
October 14, 2025

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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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