Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
This smart ring is rolling out an AI chatbot trained on medical journals
That’s why smart ring maker Movano wants to make one thing abundantly clear about its new chatbot, EvieAI: this one has been ...
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Nuclein’s DASH SARS-CoV-2 & Flu A/B Test gains FDA clearance and CLIA waiver
Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food ...
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FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
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Drug Development Costs Skewed by High-Cost Outliers
The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public ...
Can eggs spread bird flu? What you must know
The spread of avian influenza (HPAI) has also impacted the nationwide supply of poultry products, including eggs. Experts ...