Medical Devices
Federal judge upholds FDA authority over lab-developed tests
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A U.S. federal judge has ruled that the Food and Drug Administration (FDA) possesses the authority to regulate lab-developed tests (LDTs) as medical devices. This decision comes amid ongoing debates over the oversight of in-house diagnostic tools used by clinical laboratories.
FDA Issues Breakthrough Designations
The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.
New Advances in Diabetes Management Technologies
Recent developments in diabetes care include smarter insulin delivery systems and an AI-paired artificial pancreas, highlighted on September 11, 2025.
FDA Approves New Hypertension Detection Device
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The U.S. Food and Drug Administration has approved a new device for detecting hypertension, integrating advanced sensor technology. This innovation aims to improve early diagnosis and management of the condition.