Regulatorische Updates

Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.

Health Canada reports Stryker’s LP35 may not display the “CHECK RHYTHM / ECG Analysis Inconclusive” message, though shock advisories and therapy remain unaffected.

Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to possible adhesive shortage causing ceramic tip detachment.

A debate in Seoul proposes broadening health‑insurance benefits for continuous glucose monitors to include type 2 diabetes and shifting reimbursement to a device‑support model, which could benefit pharmacies.

A policy forum discussed expanding CGM insurance coverage to insulin‑treated type 2 diabetes patients and shifting reimbursement to a direct benefit system.

NECA reported that two autologous platelet‑rich plasma treatments – nasal injection and rotator‑cuff injection – were deemed safe and effective by the 4th New Medical Technology Evaluation Committee.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.

Gentherm Medical reports overheating in 0.53% of devices, potentially causing shutdowns, but no harm reported.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.

Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.

A brief summary of the MHRA’s latest safety advice for medicines and medical device users.

A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.