Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

Shots:Alife Health has reported the European CE mark approval of Embryo Predict, an AI-based embryo selection software for in vitro fertilization (IVF)Alife will initiate the rollout of Embryo Predict across selected IVF clinics in the EU, building on the company’s progress in the US with the Clinical Decision Support platform & collaborations with…

ByRidhi Rastogi3 days ago

NEWS

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots:Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…

ByRidhi RastogiOctober 15, 2025

NEWS

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots:Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mappingvMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardiaThe system also integrates with lab workflows to deliver rapid, non-invasive,…

ByRidhi RastogiOctober 8, 2025

NEWS

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots:Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial AssaysPanther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…

ByRidhi RastogiOctober 3, 2025

NEWS

AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

Shots:AVITA Medical has received European MDR CE Mark approval for Recell Go to promote healing in burns & traumatic or surgical wounds; commercialization to begin in select EU states, incl. Germany, Italy, & the UKRecell Go is a point-of-care device that allows clinicians to create a suspension of a patient’s own skin cells from…

ByRidhi RastogiSeptember 15, 2025

NEWS

QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Shots:QIAGEN has obtained European CE-IVDR certification for its QIAstat-Dx Meningitis/Encephalitis (ME) Panel to diagnose CNS infections, securing CE-IVDR approval for its entire QIAstat-Dx syndromic testing systems & panelsThe QIAstat-Dx ME Panel offers CNS infection coverage with 16 clinically relevant targets, incl. cytomegalovirus to meet current clinical needs & exclusive Streptococcus pyogenes detection to…

ByRidhi RastogiSeptember 11, 2025

NEWS

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Shots:Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritisAdditionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UKGAE aims to reduce knee pain by advancing a small catheter into the…

ByRidhi RastogiSeptember 9, 2025

NEWS

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 Q4’25Approval 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

NEWS

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) clearanceVivid 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

NEWS

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

Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

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

Contact US

OUR INFORMATION

FOLLOW US