HHS Cuts Threaten Device Security Oversight
A House Energy and Commerce subcommittee hearing Tuesday on legacy medical device safety quickly became a platform for Democrats to voice concerns over massive staffing cuts at Health and…
Study Reveals Alarming Reporting Delays
A groundbreaking study published in The BMJ has uncovered a disturbing trend in the medical device industry: nearly one-third of adverse event reports are submitted late to the FDA. More…
Essential FDA Guidelines Transform AI Medical Devices
Revolutionary Changes in Medical Device Regulation
The U.S. Food and Drug Administration is introducing groundbreaking marketing submission recommendations for AI-enhanced medical devices. These guidelines will provide comprehensive oversight throughout…
Exclusive: NHS England will consult on controversial plans to consolidate patient data from England’s clinical registries in a single platform, following opposition from patient groups.
In 2022, NHSE announced that it would combine more…
Patient groups for people with blood disorders have raised concerns about NHS England’s plans to consolidate the country’s clinical registries in a single platform.There are more than 100 clinical registries in England – many…
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Bad hardware components lie behind many failures in medical devices, according to Oshri Cohen, CEO of Cybord. The devices contain tens of computer chips and other components, so measuring quality becomes a tedious process.
Compounding…
