FDA LDT litigation could be ‘train wreck in the courts’
Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears …
Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears …
The US FDA has revoked the Emergency Use Authorization (EUA) for Cue Health’s two Covid-19 tests and has classified the …
The new edition of our digital magazine is out now – you can read it online for free. Here are …
CMR Surgical has secured US Food and Drug Administration (FDA) approval for its state-of-the-art Versius Surgical Robot, marking a significant …
Noom has unveiled body scan technology that it says will help monitor and manage muscle mass loss in patients taking …
Abbott Laboratories has reported sales of $10.6bn for the third quarter (Q3) of 2024, as against $10.4bn in Q2 2024, …
Massachusetts and Singapore-based biotechnology company Sunbird Bio has raised $14m to advance the clinical development of its blood-based diagnostic platform …
Researchers at University College London (UCL) and University College London Hospitals (UCLH) in the UK have developed an AI-based tool …
NovoCure’s Optune Lua, a wearable indicated for use alongside PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel in adult patients with metastatic non-small …
ONWARD Medical has acquired an exclusive licence from CEA for the development and commercialisation of the WIMAGINE Brain-Computer Interface (BCI) …
GE HealthCare has collaborated with University Medicine Essen (UME) to establish a new Theranostics Centre of Excellence in Germany to …
Device companies are establishing manufacturing operations outside of China to reduce dependence on Chinese manufacturing, but setting up facilities in …
One year after unveiling a timeline for its general surgical robot, Johnson & Johnson (J&J) has submitted an investigational device …
The Cardiac Rhythm Management (CRM) space is comprised of devices that are used to restore the natural synchronised pumping rhythm …
Aspira Women's Health has received approval from the New York State Department of Health's (NYDOH) Clinical Laboratory Evaluation Program (CLEP) …