The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ...
The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...
On October 1, 2024, CytoSorbents (NASDAQ:CTSO) announced the submission of its DrugSorb-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback