PRAIS 2.0 – Page 12 – Regional Platform on Access and Innovation for Health Technologies

Early Alert: WATCHMAN Access System Issue from Boston Scientific

Murilo Freitas - 04:00, 5 de August de 2025135

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-watchman-access-system-issue-boston-scientific

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Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy

Murilo Freitas - 04:00, 5 de August de 2025126

BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-correction-philips-respironics-updates-use-instructions-bipap-a30-a40-and-v30

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FDA Names Top HHS Lawyer as Chief Counsel

Murilo Freitas - 19:42, 3 de August de 2025107

FDA Names Top HHS Lawyer as Chief Counsel
http://www.fda.gov/news-events/press-announcements/fda-names-top-hhs-lawyer-chief-counsel

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FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication

Murilo Freitas - 04:00, 31 de July de 2025113

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

http://www.fda.gov/safety/medical-product-safety-information/fda-requiring-opioid-pain-medicine-manufacturers-update-prescribing-information-regarding-long-term

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