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 pathologyApproval 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…
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 underwayApproval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…
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 approvalReCerf 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…
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 2026AiMIFY has depicted consistent efficacy across extensive validation data, incl. diverse pts demographics, pathologies, lesion sizes, MRI sequences, scanner vendors, & acquisition orientations…
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 scansCINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
Shots:AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025Dermalyser 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…
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 surgeriesApproval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…
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 H2’25Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with…
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…
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…

