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 ...
Rigorous testing demonstrates robust antimicrobial performance against bacterial strains relevant to cardiac implanted electronic device (CIED) ...
On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...
The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable ...
Medical Device Network on MSN4d
FDA tags Becton, Dickinson and Company infusion software recall as Class IProblematic software has been the cause of multiple infusion pump recalls in the medical device industry over the past few ...
Medical Device Network on MSN6d
FDA tags Medtronic embolisation device recall as Class IMedtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
Dexcom forecasts total annual revenue of $4.6bn for 2025, up from the $4bn generated in 2024. Image credit: Shutterstock/MichaelVi. Dexcom is still expected to hit ...
The FDA told its staff Monday that employees responsible for reviewing drugs, medical devices, and tobacco products aren’t eligible to take a $25,000 voluntary buyout to depart from the agency. The ...
According to an FDA notice, all customers should stop using the system immediately, and Philips is coordinating returns and credits for the device ... the recall as Class I, its most serious ...
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