The FDA has approved the first prescription, at-home neuromodulation therapy for individuals with major depressive disorder ...
The FDA seeks the advice of healthcare professionals on medical device labeling and has opened a 60-day comment period, according to a Mass Device report. The survey aims to find out healthcare ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
INTRODUCTION As of August, over 30 medical devices were approved by the US FDA alone, in 2019. Given recent technological advances and the increasing complexity of such products, the need for proper ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...