Aug 14, 2023
The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities.
Apr 11, 2023
The Environmental Protection Agency today proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide (EtO), a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative…
Mar 30, 2023
Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain cybersecurity requirements if they connect to the internet and contain software and technological characteristics vulnerable to cybersecurity…
Nov 21, 2022
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic…
Nov 2, 2022
The FDA revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing, and designated the recall of 60,500 filters used in breathing systems a Class I recall.
Oct 17, 2022
All hospitals may request a backup controller with modified software for the Heartware Ventricular Assist Device System to use in certain circumstances if the primary controller fails to restart the pump, the Food and Drug Administration announced today.
Sep 12, 2022
The FBI today released recommendations to help protect medical devices from cyberattacks that can threaten health care operations, patient safety, and data privacy and integrity, citing a growing number of unpatched medical device vulnerabilities.
Aug 30, 2022
The AHA last week encouraged the Bureau of Land Management to work with the Health and Human Services Assistant Secretary for Preparedness and Response, the Centers for Medicare…
Aug 26, 2022
The Food and Drug Administration yesterday provided an update on the HeartWare Ventricular Assist Device system.
Aug 2, 2022
In a new report initiated by Chief Operating Officer Jeff Williams, Apple ties together its expansive devices and applications, its partnerships with hospitals and health systems and work with researchers.