The Sentinel Camera aims to address critical gaps in retinal disease screening by offering a portable device that captures high-quality images that require no dilation of the eye. AI Optics, an ...
If you buy through a BGR link, we may earn an affiliate commission, helping support our expert product labs. For the first time in over two decades, the U.S. Food and Drug Administration (FDA) has ...
AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality ...
The Food and Drug Administration on Thursday authorized marketing of 20 nicotine pouches — the first time the products have been greenlit by the agency. Nicotine pouches are tobacco-free sachets ...
Breadcrumbs sold for months throughout the United States contain an undeclared allergen and are being recalled for safety reasons, the Food and Drug Administration announced on its website on Jan.
With just days left in the Biden administration, the Food and Drug Administration on Tuesday unveiled its highly anticipated proposal to require manufacturers to display nutrition information on ...
Two U.S. legislators have introduced a bill that would give the FDA the ability to collect microbial samples at feed lots during foodborne illness outbreaks. Representative Rosa DeLauro ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
The Food and Drug Administration’s action affects red dye No. 3, which was approved for permanent use in food and ingested drugs more than 50 years ago. The decision comes more than two years ...
The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals. The drug, Journavx, or suzetrigine, was approved to treat moderate to severe ...
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