Inogen, Inc., a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) ...
EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ) has issued an update.
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...
It specifies that by 2035, China expects to fully ensure the safety, efficacy and accessibility of drugs and medical devices, ...
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
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