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FDA Approves Gore's VIABAHN Endoprosthesis for Endovascular Treatment of In-Stent Restenosis

September 22, 2014 9:22 am | by The Associated Press | News | Comments

W. L. Gore & Associates, Inc. (Gore) today announced that the Food and Drug Administration (FDA) has approved the GORE VIABAHN Endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). Now...

Congress Tackles LDT Regulation: IVD Innovation and the Device Tax

September 19, 2014 2:20 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight...

Industry Associations Support Continued Efforts to Repeal Device Tax

September 19, 2014 1:49 pm | by MITA, AdvaMed, and MDMA | News | Comments

The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today announced their collective support for the continued bipartisan efforts to...

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Ideal Cordless Ultrasonic Dissection Device for Each Patient and Procedure

September 18, 2014 10:53 am | by Covidien plc | News | Comments

Covidien plc today announced the expansion of its Sonicision Cordless Ultrasonic Dissection Device portfolio, following U.S. Food and Drug Administration 510(k) clearance of three additional device lengths: 13 cm, 26 cm, and...

Terminology, Training Take Center Stage at AAMI/FDA Ventilator Summit

September 18, 2014 9:48 am | by AAMI | News | Comments

To improve the safe and effective treatment of patients, healthcare delivery organizations and medical device manufacturers must standardize the nomenclature for ventilator technology and improve training for clinicians on these vital pieces of...

CE Mark for Boston Scientific's Deep Brain Stimulation System for Treating Tremor

September 17, 2014 9:17 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark for the Vercise Deep Brain Stimulation (DBS) System for the treatment of tremor, including the most common form of this movement disorder known as essential tremor (ET). Tremor is characterized...

FDA Issues Final Guidance for In Vitro Companion Diagnostic Devices

September 17, 2014 8:30 am | by Jonathan S. Kahan, Susan Tiedy-Stevenson, and Randy Prebula, Hogan Lovells US, LLP | Articles | Comments

On July 31, 2014, the Food and Drug Administration (“FDA” or “the agency”) announced the publication of a final guidance to industry describing the agency’s current thinking about the development and regulation of in vitro companion diagnostic...

Personal KinetiGraph for Assessment of Parkinson's Disease Symptoms

September 16, 2014 10:33 am | by Global Kinetics Corporation | News | Comments

Global Kinetics Corporation, a leading mobile health technologies company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the marketing of the company's Personal KinetiGraph (PKG) technology designed to improve the...

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Flowonix Submits PMA Supplements for Prometra Implantable Pump System

September 16, 2014 8:58 am | by Flowonix | News | Comments

Flowonix Medical Inc., a medical device company focused on providing advanced, implantable drug delivery solutions, today announced that it has submitted Premarket Approval (PMA) supplements to the U.S. Food and Drug Administration (FDA)...

Congress Tackles LDT Regulation: FDA Authority and Adverse Events

September 15, 2014 10:27 am | by Richard Park, Contributing Editor | Blogs | Comments

Last week, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight of laboratory...

Quantel Medical's Vitra PDT Laser Receives CE Mark Approval

September 15, 2014 9:48 am | by PR Newswire | News | Comments

Quantel Medical today announced CE Mark approval for its Vitra PDT photodynamic therapy laser platform, for the treatment of polypoidal choroidal vasculopathy (PCV) and central serous retinopathy (CSR). Quantel, the sole manufacturer of this...

FDA Approves New Styles Of The MENTOR MemoryShape Silicone Breast Implant

September 15, 2014 9:41 am | by The Associated Press | News | Comments

Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration (FDA) has approved four additional styles of the MENTOR MemoryShape Breast Implants, expanding its suite of silicone breast...

St. Jude Medical Announces Launch of OPTIS Integrated System

September 15, 2014 9:38 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the company has secured CE Mark and FDA clearance for the new OPTIS Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools...

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Symetis Receives CE Mark Approval for TAVI System

September 12, 2014 2:55 pm | by Symetis | News | Comments

Symetis SA, the leading European developer of transcatheter aortic valve implantation (TAVI) systems, announced today the launch of ACURATE neo, its 15F compatible transfemoral TAVI system. Commercial implantations started early September after...

Strategize for Regulatory and Market Approval

September 12, 2014 8:30 am | by Brian Weller, VP of Quality/Regulatory Affairs, D&K Engineering | D&K Engineering | Blogs | Comments

Clearly define your value proposition. The first critical step in a serious development effort is to show a compelling need in the marketplace for your device. It may seem obvious, but history shows that often the biggest barrier to overcome...

Silicon Valley Struggles to Speak FDA's Language

September 11, 2014 10:24 am | by Matthew Perrone, AP Health Writer | News | Comments

From Apple's new smartwatch that tracks heartbeats to contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many...

Medtronic NC Euphora Coronary Balloon Receives FDA Clearance

September 11, 2014 9:58 am | by Medtronic | News | Comments

Medtronic, Inc. today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora Noncompliant Balloon Dilatation Catheter. The new device will be featured for the first time in the United States at the...

AdvaMedDx Supports FDA Oversight of LDTs

September 11, 2014 9:24 am | by AdvaMed | News | Comments

Andrew Fish, executive director of AdvaMedDx, testified before the U.S. House of Representatives Energy and Commerce Committee today in support of FDA taking a risk-based approach to the regulation of lab-developed tests (LDTs), which have...

AdvaMed Questions FDA Classification Proposal

September 11, 2014 9:20 am | by AAMI | News | Comments

Citing an increased burden on industry, the Advanced Medical Technology Association (AdvaMed) has asked the U.S. Food and Drug Administration (FDA) to revisit its proposed amendments to regulations governing the classification and reclassification...

CE Mark for Breathe Technologies’ Non-Invasive Open Ventilation System

September 10, 2014 9:18 am | by PR Newswire | News | Comments

Breathe Technologies, a developer and manufacturer of innovative medical technologies for patients with respiratory insufficiency diseases and neuromuscular diseases, announced today that it received CE Certification for its Non-Invasive Open...

Mayo Clinic and IBM Task Watson to Improve Clinical Trial Research

September 8, 2014 1:58 pm | by Mayo Clinic | News | Comments

Mayo Clinic and IBM have announced plans to pilot Watson, the IBM cognitive computer, to match patients more quickly with appropriate clinical trials, beginning with research studies in cancer. A proof-of-concept phase is currently underway...

Olympus Launches New Hemostasis Clip with Advanced Control for GI Endoscopy

September 8, 2014 10:28 am | by PR Newswire | News | Comments

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the commercial availability of its 510(k) cleared QuickClip Pro hemostasis...

Quality Products/Services to our Aging, Technologically Astute Population

September 5, 2014 8:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Software | Blogs | Comments

As the world population’s average age is increasingly rising, the home health industry is continuing to grow and mobile healthcare-related technology is evolving. As a result, more digital health companies and mobile devices will emerge...

FDA Clears Tinnitus Therapy System for Mobile Devices

September 4, 2014 10:11 am | by Otoharmonics | News | Comments

For use in temporarily relieving the symptoms of tinnitus, the Levo System is a personalized, neuroscience-based sound therapy. Leveraging the brain’s natural cognitive abilities, Levo identifies and maps an individual’s unique sound print...

Keeping Pace: A Continuous Improvement Process

September 4, 2014 8:30 am | by Bill Betten, VP of Business Solutions, Medical/Life Sciences, Logic PD | Blogs | Comments

I believe it is important that the FDA continuously revisit their decision regarding medical device apps. As of 2013, the FDA had cleared and registered just over 100 medical apps, nowhere near the current pace of app development, which...

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