bioAffinity Technologies’ Vice President of Diagnostics, Dr Jennifer Rebeles, has contributed to a new set of guidelines for flow cytometry testing on rare matrix samples. The peer-reviewed paper, published in Cytometry Part B: Clinical Cytometry, addresses the challenges and considerations in validating assays with unique sample types.
AtriCure has announced regulatory approval for the sale of its EnCompass® Clamp in CE-marked countries within the European Union. This development follows the device’s FDA 510(K) clearance and subsequent launch in the United States in 2022.
FUJIFILM Healthcare Europe has announced that its high-end ultrasound system, the ARIETTA 750 FF ENDO, is now compatible with FUJIFILM’s ultrasound endoscopes and endobronchial ultrasound scope. This advancement allows clinicians to fully leverage FUJIFILM’s endoscopic technology during diagnostic and therapeutic procedures.
Vitestro, a Dutch medical robotics firm, has announced that its autonomous blood drawing device has received CE marking, making it the first such device to be approved for commercial use in the European Union. This milestone, achieved in July 2024, signifies the device’s compliance with the European Medical Device Regulation (MDR) standards for safety and […]
Neurotechnology firm Synchron has announced the incorporation of OpenAI’s generative artificial intelligence (AI) into its brain-computer interface (BCI) platform, introducing a novel chat feature. This integration aims to enhance the capabilities of Synchron’s BCI technology, enabling individuals with severe paralysis and loss of upper limb mobility to interact with digital interfaces through thought alone.
Oticon Medical has announced that its Sentio System, the company’s first active transcutaneous bone conduction hearing system, has received clearance from the U.S. Food and Drug Administration (FDA). This innovative system aims to provide the established benefits of the company’s Ponto System whilst offering a transcutaneous option.
Royal Philips has announced the successful first implantation of its Duo Venous Stent System following premarket approval from the U.S. Food and Drug Administration. The device is indicated for treating symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI).
Royal Philips, a leader in health technology, has launched a new cardiac care platform aimed at transforming diagnostic cardiology in Europe, the Middle East, and Africa. The Philips Cardiac Workstation utilises sophisticated algorithms to expedite the collection and processing of electrocardiograph (ECG) data, potentially streamlining care and helping to prioritise high-risk patients.
GE HealthCare has introduced SIGNA MAGNUS, a novel head-only magnetic resonance imaging (MRI) scanner designed to advance neuroscience research. The device, which is currently pending FDA 510(k) clearance (it is not yet CE marked), aims to overcome the performance limitations of conventional whole-body MR systems that have historically constrained neurological and psychiatric research.
Siemens Healthineers has announced the launch of the Biograph Trinion, a cutting-edge positron emission tomography/computed tomography (PET/CT) scanner that boasts high performance, energy efficiency, and a wide array of clinical capabilities.
April 2024
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