ADLINK Technology today announced that its San Jose Manufacturing Center (SJMC), a California facility has secured ...
A medical device manufacturer and its owner have agreed to pay $550,000 to settle a lawsuit alleging that they told health ...
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
In an agency first, the FDA has cleared a system designed to clean out the complex inner channels of flexible endoscopes—a ...
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
Under Paulley's leadership, Aura Wellness has secured FDA clearance for PEMF devices and plans to launch new accessibility programs, including rental options, payment plans, and Medicare/Medicaid ...
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
Design Cross sectional study. Setting The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022. Participants Medical ...
Manufacturers urge the govt to review medical device tariffs as the Centre considers cutting import duties on them in India.