Lungpacer Medical announced that it received FDA investigational device exemption (IDE) approval to begin a trial for its ...
FDA, of an Investigational Device Exemption IDE, supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first ...
"Receiving an IDE from the FDA is a landmark achievement for Newronika," said Dr. Lorenzo Rossi, Co-Founder and CEO of Newronika. "It affirms the potential of our adaptive DBS system to fill an ...