Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation
May 1, 2026
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.
Orchestra BioMed (Nasdaq:OBIO) announced today that it received a second FDA breakthrough device designation for its AVIM therapy.
GRAND RAPIDS, Mich., April 30, 2026 /PRNewswire/ — Capitan Orthopedics, Inc. (https://capitanortho.com/) announced today that it has been granted Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its SupraSpacerTM implant.
FDA authorization marks critical milestone enabling advancement of next-generation bone regeneration therapy for patients with degenerative spinal diseases
Avatar’s software translates CT and MR imaging data into 3D images to streamline surgical planning and operating room workflows.
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Mosaic Neo mitral bioprosthesis and began its U.S. launch.
Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in children.
LAGUNA HILLS, Calif., April 29, 2026 /PRNewswire/ — Prelude Corporation (PreludeDx™), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the AidaBREAST® test.
HERSHEY, Pa., April 29, 2026 /PRNewswire/ — Chest Wall Innovations, a medical device company focused on advancing the standard of care in chest wall surgery, today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its PC Fix Rib Fixation System on April 24, 2026, clearing the path for U.S. commercialization.