Medical Device Technology
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…
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.
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.
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.
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 & Medicaid Services, and the Food and Drug Administration to assist in taking steps to protect access to helium prior…
Medtronic's HeartWare Ventricular Assist Device system recall: Get the latest updates on controller port pin damage and pump weld defect. Stay informed.
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.
CVS Health and Walgreens recently launched clinical trials businesses with an eye toward reducing research costs and making it easier for historically underrepresented racial and ethnic groups to participate in drug and medical device studies.
The House voted to pass legislation that would reauthorize FDA user fee programs.
The recent Healthcare Information and Management Systems Society (HIMSS) Global Conference gave tech firms, pharmacy retailers and provider organizations a chance to share insights about digital advances and how they may impact future health care delivery. Here’s what caught our attention during…