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....
Opportunity for broader impact as 70% of key opinion leaders interact with only one biopharma...
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 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....
Initial clinical study results will inform pivotal clinical trial in U.S. and Europe...
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....
UK-based The Rodnight Partnership ties up with India's Pluss...
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....
Published in The Journal of Vascular Access (JVA), study shows company's patented patient monitoring system detects IV infiltrations and extravasations earlier than clinicians...
Getinge announces clearance from the US FDA for Servo-air® Lite, a wall gas independent non-invasive mechanical ventilator....
