Europe

Inbiome Shatters Diagnostic Delays: IVDR-Certified Platform IDs Bacteria in 5 Hours Across EU Hospitals

Hours, Not Days: EU Approval Accelerates 5-Hour Pathogen ID for Critical Cases. Molecular Fingerprinting: AI-Powered ‘DNA Barcode’ Spots 200+ Species, Including Uncultivable Pathogens. Hospital Laboratories Across Europe Now Have Immediate Access To a Fully Certified, Untargeted Molecular Diagnostics Platform. ...

ZEISS Receives FDA Clearance for INTRABEAM 700 – Germany

Robotic-Assisted Platform Enhances Intraoperative Radiation Therapy for Neuro-Oncology and Breast Cancer Treatments...

Orexo Reports Positive Data for Powder-Based Intranasal Vaccine with AmorphOX® Technology – Sweden

The collaboration is in line with Orexo's strategy to broaden the use of its powder-based drug delivery technology, AmorphOX®....

Sectra Expands Fully Managed AI Offering to Pathology with New Paige.AI Partnership – Sweden

Collaboration Enhances Cancer Diagnostics by Integrating Advanced AI into Unified Imaging Workflows...

Osteopore secures European approval for custom orthopaedic and cranial implants

• Osteopore secures European Union Medical Device Regulation (EU MDR) approval to supply its cutting-edge custom orthopaedic and cranial implants. • EU MDR approval unlocks opportunities to offer high-value, custom implants to Europe, in addition to off-the-shelf implants, introducing new revenue streams. • Regulatory clearance validates Osteopore’s orthopaedic and cranial products in Europe, strengthening the Company’s positioning in the market. • The European orthopaedic market is projected...

Exactech Unveils Next Generation of Predict+® for Enhanced Shoulder Replacement Outcomes – U.S.

Advanced Machine Learning Tool Integrates with Shoulder Planning App to Personalize Surgical Predictions...

TOOsonix & Consultronix Partner to Bring Advanced Dermatological Therapy to Poland

Strategic collaboration extends TOOsonix's reach into Poland, addressing skin diseases for a population of over 37 million....

Immunovia’s Next-Gen Blood Test Outperforms CA19-9 in Detecting Early-Stage Pancreatic Cancer

New results from the VERIFI study show Immunovia's test accurately detects 77% of early-stage cases and maintains strong specificity across diverse high-risk groups—strengthening commercial launch plans for Q3 2025....

Subtle Medical’s AI-Powered SubtleHD™ Secures CE Mark, Bringing Faster, Higher-Quality MRI Imaging to Europe

Innovative software enhances MRI scan quality, reduces scan times by up to 80%, and optimizes radiology workflows without requiring hardware upgrades. ...

Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant

Zimmer Biomet Secures FDA Clearance for Persona® Revision SoluTion™ Femur, Expanding Options for Metal-Sensitive Knee Implant Patients...