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UK MHRA pilots AI Airlock regulatory sandbox
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its artificial intelligence (AI) Airlock sandbox model designed to …
Four ways the vaccine rush will define infectious disease trends for CROs in 2024
The global healthcare sector has witnessed both unprecedented challenges and achievements over the past few years, most notably during the …
OrthoXel’s Vertex Hip Fracture Nail system obtains US clearance
OrthoXel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Vertex Hip Fracture Nail (HFN), …
Field Medical begins ventricular PFA technology trial
Field Medical has announced the commencement of first-in-human trials for its FieldForce pulsed field ablation (PFA) system at Na Homolce …
Reflow Medical eyes follow-up data in retrievable stent trial
Reflow Medical has completed enrollment in a clinical trial evaluating its retrievable stent for the treatment of vascular lesions in …
Tandem’s insulin pump app glitch triggers FDA Class I recall
The US Food and Drug Administration (FDA) has issued a Class I recall, the most serious designation for a medical …
Skin in the game: the latest issue of Medical Technology is out now
The new edition of our digital magazine is out now – you can read it online for free. In this month’s edition, …
ProAxsis awarded Innovate UK grant for respiratory monitoring
Belfast-based ProAxsis has been awarded an Innovate UK grant to support a project to develop a remote respiratory monitoring tool. Alongside …
Rakovina expands collaborations to leverage AI platform
Rakovina Therapeutics is expanding research collaborations with Canada-based Pharma Inventor, and the University of British Columbia (UBC) to expand research …
FDA issues warning on Getinge device amid quality concerns
The US Food and Drug Administration (FDA) has urged healthcare providers not to use certain Getinge devices amid concerns that …
Biosense introduces CARTO 3 System Version 8
Cardiac arrhythmia diagnosis and treatment specialist Biosense has launched CARTO 3 System Version 8, a 3D heart mapping system used …
4C Medical’s AltaValve gains dual breakthrough designations from FDA
4C Medical Technologies has secured dual breakthrough device designations from the US Food and Drug Administration (FDA) for its AltaValve …
Vivalink introduces new solution for MCT and Holter monitoring
Vivalink, a digital healthcare solutions provider, has launched a new ambulatory cardiac solution for mobile cardiac telemetry (MCT) and Holter …
iHealth’s COVID-19/Flu rapid test secures FDA EUA
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for iHealth Labs’ new COVID-19/Flu A&B rapid …
UK report warns that economic instability is threatening life sciences sector
A report published by Medicines Discovery Catapult (MDC) is urging the UK life sciences sector to boost investment following findings …