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The system is designed to be used in clinical trials and research studies, and can measure vital signs, sleep metrics, general activity and posture. 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
New Zealand’s Medicines and Medical Devices Safety Authority is proposing fee increases for the majority of its services, including reviewing new devices and GMP inspections. Read More
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple function devices. Read More
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Read More