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Roche
NEWS

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…
December 2, 2025

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NEWS

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…
December 1, 2025

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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…
November 21, 2025

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NEWS

Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…
November 13, 2025

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NEWS

BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

Shots: BD has received 510(k) clearance & CE Mark for its EBP & EBP plus panels on the BD COR System to detect gastrointestinal bacterial pathogens from a single stool swab using PCR-based testing EBP detects multiple enteric bacterial pathogens, incl. Salmonella, Campylobacter (jejuni, coli), Shigella/Enteroinvasive E. coli, & Shiga toxin-producing E. coli, while EBP plus…
November 4, 2025

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NEWS

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots: Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025 Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…
October 15, 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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INSIGHTS+

Disease of the Month – Rosacea 

Shots:  Rosacea is a chronic skin condition characterized by facial redness, acne-like breakouts, and flushing. It may cause enlarged blood vessels and small pus pus-filled bumps   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide. These reports provide a comprehensive overview of disease, including their…
August 27, 2025

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TOP 20

Top 20 Diagnostics Companies of 2025 

Top 20 Diagnostics Companies of 2025  Shots:  Driven by continuous innovation and enhanced precision, the diagnostic industry is advancing rapidly, transforming the way healthcare is delivered  In 2025, the global diagnostic testing market is valued at approximately $207.96B in 2025 and is projected to grow to around $272.9B by 2034, reflecting a CAGR of 3%.…
May 29, 2025

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