MedTech Spectrum

Article Name Europe

Brainomix and Nanoflex Robotics to Collaborate on an AI-Assisted Robotic System for Remote Stroke Intervention

Brainomix Awarded Innovate UK Grant to Collaborate with Swiss-based Nanoflex Robotics

13th October, 2023

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.

13th October, 2023

Freudenberg Medical opens expanded manufacturing facility, creating 100 new jobs in Ireland

New roles and additional footprint expansion to support global growth

09th October, 2023

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.

28th July, 2023

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

27th July, 2023

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 decisions and fostering personalized consultations that actively engage patients in their treatment journeys.

25th July, 2023

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.

25th July, 2023

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

21st July, 2023

Devyser's NGS Products for Kidney Transplants Get IVDR Approvals

Devyser's novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplanted patients fulfill IVDR requirements in Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm Devyser's two NGS products meet the established safety, efficacy, and quality requirements.

18th July, 2023

Pluss Advanced Technologies enhances availability of neonatal cooling device 'MiraCradle'

UK-based The Rodnight Partnership ties up with India's Pluss

18th July, 2023

France welcomes the first FLASH radiotherapy machine to treat patients

Gustave Roussy and THERYQ announce a strategic and structuring partnership to roll out and assess FLASH technology for radiotherapy. French medical technology company THERYQ, specializing in particle accelerators and radiotherapy systems, has provided Gustave Roussy's Department of Radiotherapy with the first FLASH clinical radiotherapy machine in France for treating superficial tumours.

13th July, 2023

ivWatch Technology Shows Exceptional Sensitivity in Wilhelmina Children's Hospital Study

Published in The Journal of Vascular Access (JVA), study shows company's patented patient monitoring system detects IV infiltrations and extravasations earlier than clinicians

12th July, 2023

Getinge recieves US FDA 510(k) clearance for Servo-air® Lite

Getinge announces clearance from the US FDA for Servo-air® Lite, a wall gas independent non-invasive mechanical ventilator.

10th July, 2023

IMed Consultancy Launches New UKRP-Focused Website for Medical Device Launches in the UK

IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services

05th July, 2023

Translumina strengthens technology portfolio with acquisition of Blue Medical Devices in Netherlands

Giving access to a patented, innovative, and proven next-generation Drug Coated Balloon technology

04th July, 2023

FDA Approves ImageBiopsy Labs' AI Software for Comprehensive Long Leg Radiograph Measurements

- ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays. The company previously FDA-cleared its IB Lab KOALA Knee-Osteoarthritis Labeling Assistant and intends to expand to the US with further MSK-focused software solutions.

26th June, 2023

Medtronic Unveils New Data on MiniMed™ 780G System's Meal Dosing and Time in Range in Diverse User Group

Medtronic plc(opens new window) (NYSE: MDT), a global leader in healthcare technology, is presenting a robust collection of new clinical and real-world data on the MiniMed™ 780G system. These latest data sets, which evaluated the system across a wide range of users, including historically challenging younger patients, those not meeting glycemic goals, and individuals using a simplified meal announcement leveraging fixed carbohydrate amounts instead of exact carb calculations, found that the proprietary Meal Detection™ technology supported Time in Range outcomes that exceed consensus guidelines of 70 percent. Additionally, the system is helping reduce the percent of time spent in hyperglycemia in children and adults.

26th June, 2023