Tag: FDA
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FDA Clears High-Volume Covid-19 Test
The Food and Drug Administration cleared for use in the U.S. a high-volume diagnostic for the novel coronavirus that can run on automated systems already in place.
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FDA Okays MRI with Epilepsy Brain Stimulation
A company making brain stimulation systems to treat epilepsy received regulatory clearance for MRI scans in people with its implanted devices.
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Patient Receives First Crispr Genetic Eye Treatment
An individual with a rare genetic eye disease received the first dose of an edited gene in a clinical trial of an experimental treatment for the disorder.
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Skin Cancer Apps Shown Misleading, Unreliable
A review of smartphone apps that photograph and purport to analyze skin conditions for signs of cancer shows the apps are unreliable in detecting cancer.
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A.I. Heart Ultrasound Software Cleared by FDA
Software guided by algorithms that capture top-quality ultrasound images of the heart is now authorized by the Food and Drug Administration.
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Skin Patch Senses Glucose, Emits Insulin as Needed
A bio-engineering team developed a small patch worn on the skin that in lab mice and pigs senses blood glucose levels and releases insulin when required.
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FDA Approves Children’s Peanut Allergy Drug
The U.S. Food and Drug Administration on Friday approved the first treatment for children to reduce severe allergic reactions to peanuts.
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FDA Clears A.I. Algorithms for Stethoscopes
Algorithms used in analytical software for digital stethoscopes to diagnose irregular heart rhythms received marketing clearance from the U.S. Food and Drug Administration.
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FDA Issues Draft, Final Gene Therapy Guidance
The U.S. Food and Drug Administration today issued new draft guidance for reviewing gene therapies as orphan drugs for rare diseases.
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FDA Clears Placenta Cell Brain Cancer Trial
A company developing cancer therapies with stem cells from human placentas says FDA cleared its request to start a clinical trial of a treatment for brain cancer.