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

NEWS

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

NEWS

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

NEWS

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Shots: Abbott has received European CE Mark for its Volt PFA System to treat pts with atrial fibrillation; commercialization has begun, with further expansion in EU markets expected by H2’25 Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with…

ByRidhi RastogiMarch 28, 2025

NEWS

Senseonics Seeks the CE Mark Approval for Eversense 365 System

Shots: Senseonics has filed for the CE Mark Approval of its Eversense 365 CGM system. If approved, it will be distributed in the EU (Germany, Italy, Spain, Poland, Switzerland, Sweden, & Andorra) by Ascensia Diabetes Care (Senseonics' commercial partner) Eversense offers longevity (1yr. vs 10-14 days for traditional CGMs), features a removable smart transmitter…

ByRidhi RastogiFebruary 7, 2025

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AI-Aided Colonoscopy Technology: Dror Zur from Magentiq Eye in a Dialogue Exchange with PharmaShots

Shots: Dror Zur, CEO and Founder of Magentiq Eye in a stimulating conversation with PharmaShots talks about the Lancet Digital Health Study journal that featured MAGENTIQ-COLO™, an AI-aided colonoscopy technology study MAGENTIQ-COLO™ has already got FDA clearance and a CE mark for polyp detection during colonoscopy. The renewed version includes features like polyp size estimation, polyp characterization, and additional…

BySaurabh ChaubeyMay 13, 2024

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PharmaShots Interview: Abbott’s Michael Dale Shares Insight on the CE Mark for the Next-Generation Navitor TAVI System

In an interview with PharmaShots, Michael Dale, Senior Vice President of the Structural Heart division at Abbott shared his views on the Navitor's approval in the EU for patients with severe aortic stenosis who are at high or extreme surgical risk for open-heart surgery. Shots: Abbott has received CE Mark approval for its latest-generation transcatheter aortic…

BySenior EditorSeptember 3, 2021

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

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Senseonics Seeks the CE Mark Approval for Eversense 365 System

AI-Aided Colonoscopy Technology: Dror Zur from Magentiq Eye in a Dialogue Exchange with PharmaShots

PharmaShots Interview: Abbott’s Michael Dale Shares Insight on the CE Mark for the Next-Generation Navitor TAVI System

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