MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms.
Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
BrainScope, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced recently that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and clarified overall IFU.
Edwards Lifesciences Corporation (NYSE:EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.
Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Millipede, Inc, a privately-held company in Santa Rosa, Calif., upon its recent successful completion of a first-in-human clinical study.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of its BD MAX™ enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis.
Skin has a remarkable ability to heal itself. But in some cases, wounds heal very slowly or not at all, putting a person at risk for chronic pain, infection and scarring.
Smith & Nephew plc the global medical technology business, recently announces that it has agreed to acquire Ceterix Orthopaedics, Inc, the developer of the NovoStitch Pro Meniscal Repair System.
Retia Medical, LLC, a medical device company focused on advancing the quality and clinical use of hemodynamic monitoring, today announced that its Argos Cardiac Output (CO) Monitor has received U.S.
Following months of review, the US Food and Drug Administration cleared Mariner Endosurgery’s LaparoGuard Augmented Surgical Navigation system for use in US operating rooms.
|
|
|
|
|
|
|
|
|