by admin | Dec 2, 2019 | FDA
Y-mAbs Therapeutics, a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, announced that it has submitted to the U.S. Food and Drug Administration...
by admin | Nov 4, 2019 | FDA
US-based medical device company Impulse Dynamics has secured the US FDA Supplemental-PMA approval for its next-generation, two-lead Optimizer Smart System intended for the treatment of heart failure. Impulse Dynamics has designed the Optimizer Smart System as an...
by admin | Sep 14, 2019 | FDA
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in...
by admin | Sep 12, 2019 | FDA
Checkpoint Surgical, a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief...
by admin | Aug 11, 2019 | FDA
Binx Health, the pioneer in anywhere, anytime testing for women’s health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care...
