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SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

Shots: SpinaFX has received MDR CE Mark for its Triojection System, which delivers a controlled ozone-oxygen gas mixture for procedures. Triojection also received US FDA’ IDE approval in Jun 2026 SpinaFX is engaging distribution partners to launch Triojection in priority markets, initially targeting pts with persistent pain from contained herniated discs who have failed conservative…
July 16, 2026

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HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors

Shots: HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…
July 14, 2026

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Roche
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Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
July 9, 2026

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Median Technologies Receives CE Mark for eyonis LCS to Detect and Diagnose Lung Cancer

Shots: Median Technologies has received CE Mark for eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer In testing eyonis LCS has showed 93.3% sensitivity & 92.4% specificity, with 68% reduction of False Positives & 66% reduction of False Negatives, minimizing unnecessary follow-ups eyonis Lung Cancer Screening is an AI-powered computer-aided detection & diagnosis…
July 3, 2026

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Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer

Shots: Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk In…
June 24, 2026

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Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Shots: Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…
May 13, 2026

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Roche
NEWS

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…
May 12, 2026

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