Latest Headlines

  1. Novel Intrasaccular Aneurysm Treatment Device Receives FDA PMA Approval

    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.

  2. FDA Clears Tivic Health’s Over-The-Counter Sinus Pain Relief Device

    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).

  3. FDA Clears BrainScope’s Multi-Modal, Multi-Parameter Concussion Assessment

    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.

  4. Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval

    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.

  5. Following Initial Investment Last January, Boston Scientific Acquires Millipede, Inc. For $325M

    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.

  6. FDA Clearance Adds New Viral Panel To BD’s Molecular Portfolio For GI Infection

    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.

  7. E-Bandage Generates Electricity, Speeds Wound Healing In Rats

    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.

  8. Smith & Nephew To Acquire Ceterix Orthopaedics For Up To $105M

    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. 

  9. FDA Clears Retia Medical’s Cardiac Output Patient Monitor

    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.

  10. FDA Clears Mariner Endosurgery’s Augmented Surgical System

    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.