Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.
The Environmental Protection Agency has announced plans to propose an air pollution rule to address emissions of ethylene oxide at commercial sterilizers.
Baxter International has issued a Class I recall—the most serious type of recall—for its its Spectrum V8 and Spectrum IQ infusion pumps.
Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.
The FDA’s new medical device inspections dashboard indicates that there are county level hotspots for inspection rates, but not state or region hotspots.
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FDA raised awareness of a cybersecurity vulnerability in Apache’s Log4j software library, which is used in medical devices and supporting systems.
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MED Institute obtained FDA qualification of their new Medical Device Development Tool for virtual MRI safety evaluations.
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An analysis of the U.S. FDA’s Manufacturer and User Facility Device Experience database has discovered that medical device-associated patient deaths are being mislabeled in the system—mistakes that could impede patient care.
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As the Right to Repair movement gains momentum, a Proto article asks, should hospitals be allowed to fix machines themselves?
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Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.
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The U.S. FDA's first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency's regulatory policy can help improve it.
