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NEWS

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
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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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Multi4 Medical Receives CE Mark Approval for Multi4 System to Perform Outpatient Bladder Cancer Treatment

Shots: Multi4 Medical received CE mark approval for the Multi4 System, an all-in-one bladder cancer treatment platform enabling treatment during the same outpatient visit without operating room use, anesthesia, or hospitalization The Multi4 instrument integrates local anesthesia delivery, tumor resection, automatic tissue extraction for pathology, & cauterization into a single endoscopic device, allowing awake pts…
May 6, 2026

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Pixee Medical’s Knee+ NexSight Receives the US FDA 510(k) Clearance for Knee Arthroplasty

Shots: The US FDA has granted 510(k) clearance to Knee+ NexSight, its AR-based total knee arthroplasty solution Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need of robot, console, or disposables, while delivering robotic-level accuracy with less invasive tools, reduced blood loss, & seamless workflow integration Knee+ NexSight supports…
April 28, 2026

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Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy

Shots: Kallisio has received CE certification under the EU MDR 2017/745 for its Stentra intraoral positioning system, with initial deployment planned through selected clinical pilot sites in Germany Stentra is a patient-specific intraoral device designed to support precise positioning & stabilization during head & neck radiation therapy, integrating seamlessly into existing workflows without requiring changes…
March 26, 2026

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Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Shots: Pixee Medical has received CE mark for Knee+ NexSight, its AR-based total knee arthroplasty solution, with initial procedures completed in EU & a 510(k) submission under FDA review Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need for a robot, console, or disposables, while delivering robotic-level accuracy with…
March 25, 2026

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Roche
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Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Shots: Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…
March 16, 2026

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