We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Briefs

Briefs

May 22, 2015

HeartWare Recalls Heart Kit

Framingham, Mass.-based HeartWare has initiated a Class I recall of its ventricular assist system pump driveline splice kit because they fail to work properly when exposed to excessive force. The company is asking consumers to contact them with questions and concerns. View the recall notice at www.fdanews.com/05-18-15-HeartWareRecall.pdf.

Ecuador Drafts Reg on Surgical Gloves

Ecuador has issued a draft technical regulation establishing performance and safety requirements for single-use surgical and examination/procedure gloves. The measure would apply to both domestically manufactured and imported gloves marketed in the country. Comments are due Aug. 2, and the regulation is slated for adoption Aug. 4, with a Feb. 4, 2016, effective date. Read the draft, in Spanish, at www.fdanews.com/5-15-Ecuador-Gloves.pdf.

Siemens Reaches $6M Settlement

Siemens’ imaging division has agreed to pay $6 million to settle allegations that it overcharged the U.S. Department of Defense and Veterans Affairs Administration between 2002 and 2008. Prosecutors say the company didn’t offer DOD the best price on certain purchases and hiked prices for the VA for imaging devices that were converted to newer models. Siemens denied the allegations, but agreed to settle to avoid protracted litigation, according to the settlement agreement.

Kips Bay May Shut Down

Kips Bay Medical could be forced to shut down after a clinical trial on its sole product, the eSVS mesh for use in coronary artery bypass grafting surgery, failed to prove effective. The company reorganized in January, going from 13 to eight employees. In March, the devicemaker was able to raise private equity under the condition that the mesh clinical trial reached a specified benchmark in preliminary results released earlier this month. Of an initial 10 patients implanted with the device, seven displayed lower efficacy than those in the control arm at six-month’s follow-up. The FDA issued a nonapprovable letter in September 2011 for the eSVS mesh, requesting more information on the device before allowing a feasibility study. The agency approved the study in November 2012.

Medtronic Pacemaker Meets Safety Goals

The first 140 patients in a global trial of Medtronic’s Micra transcatheter pacing system met clinical safety and performance measures, the company says. The patients suffered from a wide range of conditions, including chronic obstructive pulmonary disease and pulmonary hypertension. Mean electrical pacing measurements at one- and three-month follow-ups came in at expected ranges for all subjects. The multinational trial will eventually enroll up to 780 patients. The device — which is the size of a large vitamin, or less than one-tenth the size of most pacemakers — won CE mark approval last month.

Regulatory Affairs Postmarket Safety Submissions and Approvals

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing