Regulatory News

31. FDA Clears Tivic Health's Over-The-Counter Sinus Pain Relief Device 1/3/2019

    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).

32. FDA Clears BrainScope's Multi-Modal, Multi-Parameter Concussion Assessment 1/2/2019

    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.

33. Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval 12/28/2018

    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.

34. FDA Clearance Adds New Viral Panel To BD's Molecular Portfolio For GI Infection 12/20/2018

    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.

35. Smith & Nephew To Acquire Ceterix Orthopaedics For Up To $105M 12/18/2018

    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. 

36. FDA Clears Retia Medical's Cardiac Output Patient Monitor 12/17/2018

    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.

37. FDA Clears Mobile Medical App That Helps Patients With Opioid Use Disorder Stay In Recovery 12/10/2018

    Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD).

38. FDA Clears Bittium's ECG Device For Detection Of Arrhythmias 12/10/2018

    The new waterproof Bittium Faros ECG devices, Bittium Cardiac Navigator and Bittium Cardiac Explorer analysis software received FDA 510(k) medical device clearances in United States. The FDA 510(k) clearance received by the Bittium Faros ECG device includes the built-in algorithms for detection of arrhythmias.

39. FDA Clears iCAD's AI For Digital Breast Tomosynthesis 12/7/2018

    iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced clearance by the United States Food and Drug Administration (FDA) for their latest, deep-learning, cancer detection software solution for digital breast tomosynthesis (DBT), ProFound AI™, clearing the technology for commercial sales and clinical use in the United States.

40. Subtle Medical's AI Imaging Solution Gains FDA 510(k), CE Mark Approval 12/5/2018

    Subtle Medical, a privately-held medical device company focused on improving medical imaging efficiency and patient experience with innovative deep learning imaging technologies, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePETTM.