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NEWS

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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Bio-Techne’s Ella Platform Receives the CE-IVD Marking for Rapid, Cartridge‑Based Immunoassays

Shots: Bio-Techne has received the European CE-IVD Mark for Ella benchtop immunoassay platform to produce accurate biomarker results in clinical settings Ella is compatible with Simple Plex assays powered by R&D Systems antibodies & proteins, offering over 390 analytes across neuroscience, immunology, oncology, & cell & gene therapy to ensure consistent, high-quality data across diverse research applications…
February 17, 2026

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Abbott
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Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart

Shots: Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart) Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller…
December 19, 2025

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NEWS

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis  

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…
December 5, 2025

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Roche
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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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