October 8, 2025
When is Wearable Health Tech Actually a Medical Device?
In an era where smartwatches track our heartbeats, fitness apps nudge us to move, and sleep trackers promise a better night’s rest, the line between wellness gadget and medical device is blurrier than ever. Is your Fitbit just a fitness tracker, or does it become a regulated medical tool the moment it claims to detect [...]
GI-102 Fast Track Designation by FDA
As the project partner, BLA congratulates GI Innovation on receiving FDA Fast Track Designation for GI-102 in immuno-oncology therapy Gaithersburg,...
Dr. Li to Attend BioJapan 2025 — Let’s Connect!
Submitting an IND application to the US FDA is a significant step in the development of a new drug or...