Regulatory News

41. FDA Clears World's First High Field MR-Linac 12/5/2018

    Elekta (EKTA-B.ST) recently announced that its Elekta Unity magnetic resonance radiation therapy (MR/RT) system has received 510(k) premarket notification from the U.S. Food and Drug Administration, clearing the technology for commercial sales and clinical use in the United States.

42. FDA Grants Breakthrough Device Designation To MSD, Bayer's AI For CTEPH Pattern Recognition 12/3/2018

    Bayer announced recently that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (trade name of Merck & Co., Inc., Kenilworth, N.J., USA).

43. Abbott's HeartMate 3 Heart Pump Now FDA Approved For Advanced Heart Failure Patients Not Eligible For A Heart Transplant 10/19/2018

    Abbott announced today that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure.

44. Canada Clears Medtronic's Insulin Pump For Type 1 Diabetes 10/10/2018

    Medtronic of Canada Ltd., a subsidiary of Medtronic plc (NYSE: MDT), today announced it has received a licence from Health Canada for the MiniMed™ 670G system — the first insulin pump system in Canada that helps to stabilize glucose levels 24 hours a day by automatically adjusting basal insulin delivery based on real-time insulin needs.

45. RAPS Releases Regulatory Professional Compensation Survey Results 10/3/2018

    RAPS recently released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved.

46. FDA Approves Boston Scientific's Drug-Eluting Vascular Stent System 9/24/2018

    Today, Boston Scientific (NYSE: BSX) announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia™ Drug-Eluting Vascular Stent System, specifically developed for the treatment of peripheral artery disease (PAD).

47. FDA Approves BIOTRONIK's PK Papyrus Stent for Coronary Perforations 9/14/2018

    BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013.

48. FDA Oks Medtronic's Implantable System For Remodulin To Treat Pulmonary Arterial Hypertension 7/31/2018

    Medtronic plc (NYSE:MDT) has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin® (ISR) to treat patients with pulmonary arterial hypertension (PAH).

49. FDA Unveils FY 2019 GDUFA, BsUFA And MDUFA Fees 7/30/2018

    With the new five-year user fee programs now in their second year, generic drug and medical device companies are seeing increases in user fees while biosimilar companies are seeing decreases.

50. FDA Clears Healthy.io's Smartphone-Enabled Urinalysis Kit 7/25/2018

    Approval Helps Healthy.io Usher in Era of Medical Selfie, Leveraging Embedded Smartphone Cameras to Improve Patient Adherence and Outcomes and Curb Healthcare Expenditures.