Medline hit with FDA warning letter over angiographic syringe manufacturing failures
An FDA inspection of Medline’s facilities in December 2025 found that the company fell short of certain good manufacturing practice…
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MiRus treats first patients in STAR trial of Siegel 8-French heart valve
The randomised controlled, multi-centre, prospective trial will enrol 1,025 patients across multiple centres in the US.
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Medline hit with FDA warning letter over angiographic syringe manufacturing failures
An FDA inspection of Medline’s facilities in December 2025 found that the company fell short of certain good manufacturing practice…
MiRus treats first patients in STAR trial of Siegel 8-French heart valve
The randomised controlled, multi-centre, prospective trial will enrol 1,025 patients across multiple centres in the US.
CorTec gains FDA breakthrough designation for stroke rehabilitation BCI
CorTec's BCI aims to differentiate itself by offering brain-based communication alongside therapeutic neurostimulation.
MHRA secures $4.8m to expand AI medical device programme
AI Airlock is jointly run by the MHRA, DHSC, NHS AI Team, and Team AB, the consortium of UK Approved…
FDA approves Endospan’s aortic stent
Research suggests that over 120,000 patients suffer from aortic arch disease in the US and Europe annually, but only around…
Route 92 Medical raises $50m to support growth strategy
The proceeds will support Route 92’s growth strategy through expediting worldwide commercial expansion.
E2 raises $80m to advance VTE system’s commercialisation
FDA-cleared in December 2025, E2’s Hēlo system is indicated for the non-surgical removal of emboli and thrombi from pulmonary arteries…
J&J advances PFA portfolio with Varipulse Pro launch in Europe
Varipulse Pro introduces a new pulse sequence with lower temperature and five times faster ablation.
TRiCares gains FDA IDE to initiate tricuspid regurgitation treatment pivotal trial
TRiCares' pivotal trial will build on an ongoing early feasibility study of the Topaz TTVR system that began in January…
Egg Medical unveils new radiation protection system for clinical use
Barnes-Jewish Hospital is set to conduct the initial live case using the EggNest Complete Flex system.
