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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...

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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...

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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...

Medtronic Announces CE Mark for Recapturable CoreValve Evolut R System

September 3, 2014 9:31 am | by Medtronic | News | Comments

Medtronic, Inc. has announced CE Mark for the 23 mm CoreValve Evolut R System for transcatheter aortic valve implantation (TAVI). The novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that  advance valve...

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Ortho Development Receives FDA Clearance for Alpine Hip Stem

September 3, 2014 9:18 am | by PR Newswire | News | Comments

Ortho Development Corporation has received FDA clearance for the Alpine Hip Stem, the latest addition to its growing hip replacement product line. The Alpine Hip Stem is intended for use in total hip arthroplasty and hemiarthroplasty procedures...

FDA Approval of GE's SenoClaire - New Breast Imaging with 3D Tomosynthesis Solution

September 3, 2014 9:13 am | by The Associated Press | News | Comments

GE Healthcare has announced the FDA approval of SenoClaire, GE’s new breast tomosynthesis solution designed with a three-dimensional imaging technology. In collaboration with Massachusetts General Hospital, GE developed SenoClaire technology...

Medtronic Receives Clearance for the SHILLA Growth Guidance System

August 28, 2014 11:04 am | by Medtronic, Inc. | News | Comments

Medtronic, Inc. today announced the 510(k) clearance and launch of the SHILLA(TM) Growth Guidance System. The system is designed for treatment of skeletally immature pediatric patients less 10 years of age diagnosed with severe, progressive...

EMIT Corporation Awarded CE-Mark

August 28, 2014 10:51 am | by PR Newswire | News | Comments

EMIT Corporation announced today that it has received CE-Mark for its Hypothermx Intravenous Fluid and Blood Warming Devices with sterile fluid paths, allowing for sales expansion into the European and other OUS markets. EMIT Corporation also...

AAMI Asks FDA to Clarify Standards Expectations

August 28, 2014 10:39 am | by AAMI | News | Comments

AAMI has sought clarity on what considerations U.S Food and Drug Administration (FDA) review staff would like the association and similar organizations to take into account during the standards development and revision processes. The association...

FDA 510(k) Clearance for CardiacAssist's PROTEK Duo VenoVenous Cannula

August 28, 2014 9:33 am | by The Associated Press | News | Comments

CardiacAssist, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new PROTEK Duo venovenous cannula. The PROTEK Duo is intended for use as a single cannula for both venous drainage...

Heart Hospital to Implant Portico Transcatheter Aortic Valve System as Part of Clinical Trial

August 28, 2014 9:27 am | by PR Newswire | News | Comments

On Aug. 26, 2014, physicians at Heart Hospital of Austin became the first in Texas to implant the new Portico Re-sheathable Transcatheter Aortic Valve System—an innovative, repositionable aortic heart valve and delivery system. Heart Hospital...

Medtronic Announces First Implants in Largest-Ever, Global Trial of Cardiac Resynchronization Therapy

August 27, 2014 12:10 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced the first implants in a clinical trial that will compare patient and healthcare system outcomes - including patient mortality and hospitalizations - in heart failure patients who have cardiac resynchronization...

St. Jude Medical Resolves FDA Warning Letter for Plano Facility

August 27, 2014 9:22 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has announced that it has been notified by the U.S. Food and Drug Administration (FDA) that issues cited in the Plano, Texas, facility’s warning letter have been addressed. “We’re...

TIA Commends New FDA Approach to Medical Device Data Systems

August 26, 2014 12:01 pm | by Telecommunications Industry Association | News | Comments

The Telecommunications Industry Association (TIA), the leading association representing the manufacturers and suppliers of high-tech communications networks, today submitted comments to the Food and Drug Administration (FDA) in support...

Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Microtest Laboratories, Inc. | Blogs | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current...

Medtronic’s Viva Cardiac Resynchronization Therapy-Pacemaker Approved in U.S.

August 25, 2014 10:26 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the U.S. Food and Drug Administration (FDA) approval of its newest cardiac resynchronization therapy-pacemaker, Viva CRT-P, for indicated patients with heart failure or atrioventricular (AV) block. The Viva CRT-P...

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