
Long-term Coflex and spinal-fusion study posts registry results
ClinicalTrials.gov reports results from a completed post-approval study comparing Coflex with fusion for lumbar spinal stenosis.
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Coverage of medical innovation, devices, and technology.

ClinicalTrials.gov reports results from a completed post-approval study comparing Coflex with fusion for lumbar spinal stenosis.
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A completed Phase 2 study used dual MRI to investigate cardiopulmonary findings in people with persistent symptoms after COVID-19.
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The UK regulator has issued a safety notice concerning Dräger Atlan Anaesthesia workstations, with guidance for affected healthcare services.
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Using a standard IV infusion set instead of a blood-transfusion set may under-deliver blood or destroy red cells, potentially causing serious injury.
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Affected components in Kimal procedure packs carry risks of syringe disconnection or foreign particles and should be used only for urgent procedures when no alternative exists.
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Rare cases in which the balloon did not pass as intended have led to gastric outlet or bowel obstruction and gastric perforation, requiring prompt assessment.
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Corrective action has allowed UK sales to resume, but transplant teams are told to inspect every bag for leakage, discoloration, particles or contamination before use.
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The regulator says specified devices lack valid UKCA or CE conformity evidence, so assurance of safety, sterility and performance cannot be fully guaranteed.
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A circuit-board fault can unexpectedly stop ventilation in Astral 100 and 150 devices made before October 2024, requiring immediate access to alternative ventilation.
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The regulator cites insufficient evidence of benefit and unknown risks, including possible trauma, bleeding, pain or perforation, for products sold as gas and colic relievers.
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Users should stop using and dispose of NGPod devices after earlier incidents included a misplaced nasogastric tube and one fatal outcome, the MHRA says.
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An MHRA investigation found increased wear and corrosion risks in several cobalt-chrome modular-neck hip stems, with possible adverse tissue reactions and revision surgery.
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The UK regulator says unfiltered parenteral nutrition has been linked to adverse incidents, including a fatal embolism, and advises filters no larger than 1.2 micrometres.
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