PRAIS 2.0 – Page 6 – Regional Platform on Access and Innovation for Health Technologies

Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure

Murilo Freitas - 04:00, 14 de September de 202558

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-glucose-monitor-apps-correction-dexcom-inc-issues-correction-g7-apps-and-one-apps-due

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery

Murilo Freitas - 04:00, 14 de September de 202580

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.

http://www.fda.gov/medical-devices/medical-device-recalls/insulin-pump-correction-tandem-diabetes-care-issues-correction-certain-tslim-x2-insulin-pumps-due

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

Murilo Freitas - 04:00, 14 de September de 2025100

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-voluntary-recall-certain-bd-alaristm-pump-infusion-sets

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

Murilo Freitas - 20:08, 11 de September de 202567

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-launches-real-time-adverse-event-reporting-dashboard-cosmetic-products

Update on Alert: Defibrillation Lead Issue from Boston Scientific

Murilo Freitas - 04:00, 11 de September de 202599

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-defibrillation-lead-issue-boston-scientific

Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes

Murilo Freitas - 04:00, 11 de September de 202598

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-recall-philips-respironics-removes-certain-dreamstation-devices-due-programming-errors

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication

Murilo Freitas - 04:00, 10 de September de 2025282

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.

http://www.fda.gov/medical-devices/safety-communications/accolade-pacemaker-devices-boston-scientific-and-potential-need-early-device-replacement-fda-safety

HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation

Murilo Freitas - 19:01, 9 de September de 2025170

HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation
http://www.fda.gov/news-events/press-announcements/hhs-cbp-seize-865-million-worth-illegal-e-cigarettes-largest-ever-operation

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

Murilo Freitas - 13:04, 9 de September de 2025143

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
http://www.fda.gov/news-events/press-announcements/fda-issues-new-guidance-expand-non-opioid-options-chronic-pain-curb-misuse

PAHO launches initiative to curb rising suicide rates in the Americas

admin - 12:00, 9 de September de 2025204

PAHO launches initiative to curb rising suicide rates in the Americas

Cristina Mitchell

10 Sep 2025

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