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Inogen receives FDA 510(k) clearance for SIMEOX 200 airway clearance device
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) ...
Med Device Online3d
U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
medtechdive3d
Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
JD Supra5d
FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
Strong Growth In The Indian MedTech Industry And Global Recognition Of FDA 510(K)
Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.
JD Supra6d
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
theregreview8d
Evolving Regulatory Protections for Research Participants
In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...
US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
Canada17d
Guidance on the Food and Drug Regulations for public health emergency drugs: Overview
This document will help sponsors prepare a submission for a notice of compliance for a public health emergency drug under the regulations. It also outlines the process for meeting the post-market ...
CNN17d
Which foods are ‘healthy’? FDA has new requirements for food labels
Requirements now include limits on saturated ... Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns ...