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Investigators, institutional review boards and device trial sponsors can distinguish humanitarian device exemptions from investigational device exemptions by consulting a new draft guidance from the Centers for Devices and Radiological Health. The agency...
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The FDA Monday issued a preliminary public health notification, stating that x-rays used during CT exams may cause some implanted and external electronic medical devices to malfunction. The agency also provided recommendations to reduce the potential...
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Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced June 26 in the House to preserve state product liability lawsuits. Read More...
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The FDA has issued a consumer update on safety in pediatric medical imaging to increase awareness for the need to decrease the radiation dose administered to children during CT scanning. Read More...
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The FDA's Center for Devices and Radiological Health (CDRH) is continuing its efforts to use information from other healthcare regulators to enhance its risk assessments of manufacturing facilities. Read More...
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Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices, has received 510(k) clearance from the FDA for its DC-3 color ultrasound imaging system. Read More...
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The Korean Food and Drug Administration has approved NeuroLogica’s CereTom portable CT scanner for medical capital device imaging. Read More...
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