Impulse Dynamics secures US FDA approval for Optimizer Smart System
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 implantable device to deliver
SoniVie Receives FDA Breakthrough Device Designation For The TIVUS System In The Treatment Of Pulmonary Arterial Hypertension (PAH)
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 patients
Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device
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 electrostimulation therapy (BEST) system. The Checkpoint BEST™
binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women’s Health
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 (POC) diagnostic testing