Philips Unveils Verida to Improve Diagnostic Imaging

Shots: Royal Philips has launched Verida, a detector-based spectral CT fully powered by AI, at RSNA 2025, with availability in select markets beginning in 2026 Verida integrates AI across the entire imaging chain to deliver high-quality spectral & high-definition images with minimal noise, while enabling significant dose reductions & reducing energy use by ~45% Verida reconstructs…

ByRidhi RastogiDecember 1, 2025

NEWS

Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

Shots: The US FDA has granted 510(k) clearance to TELLTALE for the prevention of coronary obstruction in pts undergoing Transcatheter Aortic Valve Replacement (TAVR) for both native aortic stenosis & bioprosthetic valve failure FDA cleared TELLTALE following a pivotal study demonstrating the device’s safety & effectiveness for leaflet modification in pts at risk of coronary…

ByRidhi RastogiNovember 24, 2025

NEWS

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC Oncomine Dx Target Test, first…

ByRidhi RastogiNovember 21, 2025

NEWS

Zimmer Biomet Receives FDA 510(k) Clearance for ROSA Knee with OptimiZe

Shots: The US FDA has granted 510(k) clearance to ROSA Knee with OptimiZe, an enhanced version of the ROSA Knee system designed to support accurate, reproducible outcomes in robotic-assisted knee replacement surgery, with targeted rollout planned for late 2025 & broader US availability expected in Q1’26 The system introduces new features, incl. customizable surgical plan,…

ByRidhi RastogiNovember 17, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 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:    Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025 Read More: Ionis AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES) …

ByRidhi RastogiNovember 14, 2025

NEWS

Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing

Shots: The US FDA has granted 510(k) clearance to the Hemastyl gel device to support chronic wound healing The Hemastyl gel is a topical formulation that enhances the tissue-repair environment to support wound closure, while the Periwound NerveStim device works with Hemastyl to restore periwound function The Periwound NerveStim device is in final FDA approval stages, with…

ByRidhi RastogiNovember 14, 2025

NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…

ByRidhi RastogiNovember 12, 2025

NEWS

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…

ByRidhi RastogiNovember 11, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 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 Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC Read More: Daiichi Sankyo Genentech Reports P-III (ALLEGORY) Trial…

ByRidhi RastogiNovember 7, 2025

NEWS

Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

Shots: Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG) EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times The company has planned to launch EndoZip in select EU centers &…

ByRidhi RastogiNovember 7, 2025

Philips Unveils Verida to Improve Diagnostic Imaging

Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic

Zimmer Biomet Receives FDA 510(k) Clearance for ROSA Knee with OptimiZe

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)

Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

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