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NEWS

UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio

Shots: UroViu has received European CE Mark approval for its cystoscope & hysteroscope portfolio, incl. the reusable UV5000w Wi-Fi Handle & disposable Hystero-V, Uro-V, & Uro-GHD endoscopes UroViu’s portfolio has shown strong clinical value & efficiency in cystoscopy procedures, incl. diagnosis, cancer surveillance & minor therapeutic interventions, as highlighted in data presented at EAU &…
November 7, 2025

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NEWS

Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots: Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
November 6, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Oct 27, 2025 – Oct 31, 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:    Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome Read More: Roche Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear…
October 31, 2025

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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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