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“Our products meet rigorous internal safety standards, international standards, as well [as] the standards of the FDA and other regulatory bodies,” the company said. Read More
Australia’s Therapeutic Goods Administration plans to conduct a product safety review on ventilators used in high-care hospital settings for long-term therapy of intubated patients. Read More
The National Institute for Standards and Technology released a new cybersecurity framework that focuses on supply chain risks and risk management. Read More
The upgrade also introduces a device-based battery performance feature to monitor the battery for abnormal behavior and vibrate to alert the patient if any issues are detected. Read More
The FDA sent a letter to health care providers warning of the potential for increased image voids when using magnetic resonance angiography (MRA) imaging for follow-up of certain post neurovascular embolization coil procedures. Read More
The agency received nearly 12,000 adverse event reports relating to Essure last year, the majority of which were submitted in the last quarter of the year. Read More