PRAIS 2.0 – Page 4 – Regional Platform on Access and Innovation for Health Technologies

Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

Murilo Freitas - 04:00, 1 de July de 2025237

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.

http://www.fda.gov/medical-devices/safety-communications/cybersecurity-vulnerabilities-certain-patient-monitors-contec-and-epsimed-fda-safety-communication

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Early Alert: Infusion Pump Software Issue from Baxter

Murilo Freitas - 16:00, 30 de June de 202554

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

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-software-issue-baxter

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Early Alert: Blood Pump Controller Issue from Abiomed

Murilo Freitas - 04:00, 30 de June de 202569

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

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-blood-pump-controller-issue-abiomed

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Extended-Release Stimulants for ADHD: FDA Drug Safety Communication – FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years

Murilo Freitas - 04:00, 30 de June de 202559

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo

http://www.fda.gov/safety/medical-product-safety-information/extended-release-stimulants-adhd-fda-drug-safety-communication-fda-requires-expanded-labeling-about

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