Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
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Actualizaciones regulatorias
18 sept 2026•1 min de lectura
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices Sold to Canadian Clinics
Health Canada alerts that counterfeit laser hair removal devices marketed as “Soprano” are being sold to clinics in Canada, posing health risks and violating regulations.
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Actualizaciones regulatorias
18 sept 2026•1 min de lectura
GE Healthcare alerts on exposed sharp edge in SIGNA™ Artist cabinets
GE Healthcare reports an exposed sharp edge inside SIGNA™ Artist and Artist Evo electronics cabinets that may damage power cables and cause an electrical fault or arc flash risk.
Actualizaciones regulatorias
17 sept 2026•1 min de lectura
STERIS Alerts Users to Swelling RAPICIDE™ Part A Bottles in Certain Lots
A small number of RAPICIDE™ Part A bottles may bulge due to blocked vent caps, potentially releasing vapor and exposing users; STERIS will notify affected consignees and provide replacements.
Actualizaciones regulatorias
17 sept 2026•1 min de lectura
Philips MR Systems Export Incorrect Diffusion Data in Enhanced DICOM Format
Philips Ingenia Achieva and Intera MR scanners export DTI scans with incorrect diffusion directions when using Enhanced MR DICOM, preventing proper tractography processing.
Actualizaciones regulatorias
17 sept 2026•1 min de lectura
MHRA Review Highlights RF Safety Issues in Wireless CTG Monitors
The MHRA identified signal crossover, erroneous traces and dropouts in wireless cardiotocography systems that use radio‑frequency telemetry.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
Medtronic Identifies Reflective Material Variation in Sterile Passive Spheres
Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
Medtronic Alerts Variation in Reflective Material on Passive Spheres May Impact Navigation Tracking
Medtronic reports a variation in the reflective coating of certain sterile passive spheres, which could affect instrument detection and tracking during navigation procedures.
Actualizaciones regulatorias
16 sept 2026•1 min de lectura
MHRA Alert: Patient Hoists and Slings Pose Fatal Fall Risk
MHRA reports ongoing fatal and serious harm from patient falls involving hoists or slings, noting an average of two deaths in recent incidents.
Actualizaciones regulatorias
15 sept 2026•1 min de lectura
KMA committee condemns police non‑prosecution of Korean medicine device use
The Korean Medical Association’s special committee denounced the Dongdaemun police’s decision not to prosecute a Korean medicine practitioner for using lidocaine and Opus Dual medical devices, urging a review.
Actualizaciones regulatorias
14 sept 2026•1 min de lectura
Korean Lawmaker Proposes Health‑Medical Regulatory Sandbox Amendment
Lawmaker Kwon Chil‑seung filed an amendment to the Health and Medical Technology Promotion Act to establish a regulatory sandbox for health‑medical innovations.
Actualizaciones regulatorias
14 sept 2026•1 min de lectura
MHRA Field Safety Notices Published 7‑11 Sep 2026
MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.
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Actualizaciones regulatorias
10 sept 2026•1 min de lectura
Stryker T2 Alpha IMN Advanced Locking Screw Lot Mislabelled, 75 mm Instead of 57.5 mm
Health Canada alerts that a Stryker T2 Alpha IMN advanced locking screw lot is mislabeled, containing 75 mm screws rather than the specified 57.5 mm.