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…

ByRidhi Rastogi4 days ago

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Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Shots: CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks. Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…

ByRidhi RastogiJuly 1, 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…

ByRidhi RastogiJune 24, 2026

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FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Shots: FiberSense has received the CE Marking for its CGM System as a Class IIb medical device, with the company planning to launch in select markets, with initial orders confirmed & first deliveries expected in late 2026 The company is preparing manufacturing scale-up, logistics, customer support, & market access activities for launch, while advancing its…

ByRidhi RastogiJune 17, 2026

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Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

Shots: Vara has received CE Class IIb marking under the EU MDR for its tomosynthesis (3D mammography) AI solution, expanding its offerings for breast cancer screening programs across the EU Vara is validated for national-scale breast cancer screening, with its scale demonstrated through PRAIM, a large prospective screening study published in Nature Medicine in 2025, supporting…

ByRidhi RastogiJune 10, 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…

ByRidhi RastogiMay 13, 2026

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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…

ByRidhi RastogiMay 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…

ByRidhi RastogiMay 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…

ByRidhi RastogiApril 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…

ByRidhi RastogiMarch 26, 2026

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

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

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

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

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

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

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

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

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

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