Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…

ByRidhi Rastogi15 hours ago

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Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

ByRidhi Rastogi2 days ago

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GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Shots: The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation…

ByRidhi Rastogi2 days ago

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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 Rastogi2 days ago

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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

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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

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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

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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

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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

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

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

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