ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation

Shots: ONWARD Medical has received MDR CE Mark approval for its ARC-EX system to treat people with spinal cord injury (SCI); first EU commercial sales are expected by Q4’25 Approval was backed by extensive clinical data, incl. Up-LIFT trial published in Nature Medicine, showing 90% pts improved strength or function, 87% reported better QoL, &…

ByRidhi RastogiSeptember 8, 2025

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GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Shots: GE HealthCare has launched Vivid Pioneer, a cardiovascular ultrasound for 2D, 4D, & color flow imaging, following the European CE Mark approval & the US FDA’s 510(k) clearance Vivid Pioneer is powered by cSound architecture & XDclear tech to provide superior resolution, color sensitivity, & 4D imaging, allowing structure visualization & cardiac function assessment…

ByRidhi RastogiSeptember 2, 2025

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Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…

ByRidhi RastogiAugust 27, 2025

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Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi RastogiJuly 23, 2025

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Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots: Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi RastogiJuly 22, 2025

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MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

Shots: MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…

ByRidhi RastogiJuly 4, 2025

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Bracco Imaging & Subtle Medical’s AiMIFY Receives the European CE Mark Approval for Enhanced Brain MRI

Shots: Bracco Imaging & Subtle Medical have received the European MDR CE Mark approval for their AI-powered AiMIFY software for brain MRI; phased commercial availability expected from late 2025 to early 2026 AiMIFY has depicted consistent efficacy across extensive validation data, incl. diverse pts demographics, pathologies, lesion sizes, MRI sequences, scanner vendors, & acquisition orientations…

ByRidhi RastogiJune 16, 2025

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Avicenna.AI Receives European CE Mark Approval for its CINA-VCF Quantix and CINA-CSpine

Shots: Avicenna.AI has received the European CE Mark approval for its AI-powered tools, CINA-VCF Quantix & CINA-CSpine to detect & assess unsuspected vertebral compression fractures (VCFs) & cervical spine fractures, respectively in pts undergoing CT scans CINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…

ByRidhi RastogiJune 6, 2025

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AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

Shots: AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025 Dermalyser was validated in AI-DSMM study across 36 Swedish centers, where it analyzed 253 suspicious lesions in 228 pts, identifying 21 melanomas (11 as thin invasive & 10 as in situ). It also achieved AUROC…

ByRidhi RastogiMay 27, 2025

NEWS

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

Shots: ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeries Approval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…

ByRidhi RastogiMay 22, 2025

ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

Bracco Imaging & Subtle Medical’s AiMIFY Receives the European CE Mark Approval for Enhanced Brain MRI

Avicenna.AI Receives European CE Mark Approval for its CINA-VCF Quantix and CINA-CSpine

AI Medical Technology’s Dermalyser Receives European CE Mark Approval for Melanoma Detection

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

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