Becker's Hospital Review11d
3 medical device recalls and corrections
Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: ...
Powerful Medical Receives FDA Breakthrough Device Designation for PMcardio STEMI AI ECG Model
Press Release Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and ...
JD Supra11d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
Medical Design & Outsourcing7d
De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
Medical Device Network on MSN6d
FDA tags Medtronic embolisation device recall as Class I
Medtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
MyChesCo on MSN2d
FDA Unveils Life-Changing Drug, Urgent Device Alert, and Revolutionary Tech to Protect Your Health
The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing commitment to advancing public health and medical safety.
NBC New York29d
FDA moves to rehire medical device staffers fired only days earlier
Beginning Friday night, FDA employees overseeing medical devices and ... or about $3.3 billion, comes from fees paid by drugmakers, device and tobacco companies. The result is that broad cuts ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
MedTech Dive8d
FDA adds hemodialysis devices to shortage list amid B. Braun disruption
The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and ...
Seattle Times1mon
FDA moves to rehire medical device, food safety and other staffers fired days earlier
Beginning Friday night, FDA employees overseeing medical devices ... or about $3.3 billion, comes from fees paid by drugmakers, device and tobacco companies. The result is that broad cuts to ...