Europe

JVM Successfully Launches Next-Gen Drug Dispensing System 'MENITH' in Europe

A state-of-the-art, next-generation automated drug dispensing machine equipped with a robotic arm, independently developed by JVM, an affiliate of Hanmi Science, was successfully launched in the European market. ...

Roche's Fenebrutinib Shows Brain Penetration and Lesion Reduction in Multiple Sclerosis Patients: Late-breaking Data

Roche announced new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS) with a consistent safety profile to other fenebrutinib trials. The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis)....

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments. ...

icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants....

Veeva Pulse Uncovers Field Medical Engagement Drives 1.5x Increase in Treatment Adoption

Opportunity for broader impact as 70% of key opinion leaders interact with only one biopharma...

Fractus expands into healthcare with wireless implantable device technology

Fractus' groundbreaking antenna technology now ventures into the realm of healthcare. The company has successfully developed an innovative wireless implantable device technology, revolutionizing the way doctors remotely monitor their patients and boosting the uptake of telehealth services by leveraging wireless connectivity. With the ability to offer real-time data and feedback, this cutting-edge technology is set to greatly improve patient care, enabling doctors to make timely, informed decisi...

Inspira™ Technologies Receives Medical Devices Quality Certification, Progresses Towards EU Regulatory Approval

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it has received International Organization for Standardization (ISO) 13485:2016 Standard Certification, which is the international standard for quality management systems within the medical device industry, and a requirement for EU regulatory approval....

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Initial clinical study results will inform pivotal clinical trial in U.S. and Europe...