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....
IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services...
Giving access to a patented, innovative, and proven next-generation Drug Coated Balloon technology...
- 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....
