Empatica: We are happy to announce the clearance of the Empatica Health Monitoring Platform by the U.S. Food and Drug Administration (FDA). The Empatica Health Monitoring Platform is our full-stack remote health monitoring and data...

Another manufacturer has FDA clearance for primary diagnosis for clinical use. Be sure to check out the NanoZoomer S260MD slide scanner for primary diagnostics.  Hamamatsu Photonics K.K., a global leader in imaging technology, today...

Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma Application is based on results from the pivotal phase I/II study...

Tampa, Florida / GlobeNewswire – Digital pathology and cancer informatics provider Inspirata announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its Dynamyx digital pathology software. This clearance...

Agency holds off decision on expanding use of shot to 12-to-17-year-olds while it looks into risk of rare heart condition The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s Covid-19 vaccine for...

(RTTNews) - As we head into the fourth quarter of 2021, here is a recap of what happened on the regulatory front this month that caught our attention. Samsung Bioepis' Byooviz became the first biosimilar for Lucentis to treat macular...