Military veterans will have first access to Modius Spero vestibular stimulation ...
The Food and Drug Administration granted de novo approval to Modius Spero, marking it the world’s first neuromodulation device authorized to ...
Securing US FDA approval is a milestone for medical device companies but is only half the story with successful adoption ...
FDA to Systematically Incorporate Patient Preferences into Device Approvals US medical device regulators at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH ...
Belfast health-tech company Neurovalens has received ‘de novo’ approval from the US FDA for its prescribed treatment for ...
A neurotech firm in Northern Ireland has been given the US green light for its headset to be used for treating post-traumatic ...
Arsenal Medical announced that the FDA granted investigational device exemption approval for the RADIANT pivotal trial. The ...
For manufacturers, medical device companies, and laboratories that use the commercial diagnostic tests they produce, ...
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has announced the launch of a new electronic submission process for requesting export certificates for ...
The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...