today announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase ® LYNXâ„¢, the world's first and only pattern scanning laser indirect ophthalmoscope. LYNX is ...
Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of ...
For manufacturers, obtaining CE marking can be likened to planting a flag on foreign soil, declaring their commitment to quality and safety. For products entering the U.S. market, FDA ...
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...
Modular Medical develops patented insulin delivery technologies, aiming to improve access to glycemic control. Its founder, ...
The digital pathology software developer is raising funding that would help it to increase its head count and support its Aiosyn Mitosis Breast application.
Lynx, Norlase’s pattern scanning laser indirect ophthalmoscope, commercially launched with both FDA 510(k) clearance and a CE mark, according to a press release. The ophthalmoscope, which includes an ...
The Food and Drug Administration (FDA) has issued a recall for 60 baked products, including a variety of doughnuts, over concerns of potential listeria contamination. The recall, which impacts ...
The Food and Drug Administration has classified a recall of 60 different doughnut products to its second-highest level, the agency announced earlier this week in an update to its website.