Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software....
Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support crit...
The new manufacturing plant will commence operations by March 2025...
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....
Novel SaMD technology generates a 3D model of uterus to facilitate treatment in patients with symptomatic uterine fibroids...
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States....
Jess Ng, Country Head of Singapore and Brunei at Fortinet, unravels best practices to mitigate cyber security risks in the healthcare, clinical and pharma ecosystem...
Aevice Health, a leading provider of remote respiratory monitoring solutions for the healthcare continuum and backed by the Cedars-Sinai Accelerator, announced that its flagship medical device, the AeviceMD, has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route....
ReddyPort announced that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV)....
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....
![[L-R]: Ms. Vivien Tan, XP Business Manager, Siemens Healthineers ASEAN; Prof. Dr. dr. Lina Choridah, Sp.Rad (K), Chairwoman Indonesian Woman Imaging Society; Hendya Perbangkara, Head of Diagnostic Imaging, Siemens Healthineers Indonesia](/uploads/articles/l_r__ms_vivien_tan_xp_business_manager_siemens_healthineers_asean-24188.jpg)
