Advertisement
Regulatory
Subscribe to Regulatory
View Sample

FREE Email Newsletter

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...

Advertisement

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...

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...

Advertisement

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...

Advertisement

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...

Assessing FDA’s Final Guidance on Companion Diagnostics

August 22, 2014 2:28 pm | by Richard Park, Contributing Editor | Blogs | Comments

On the same day that FDA released its draft guidances on regulating laboratory-developed tests (LDT), the agency also issued a final guidance on the development, review, and clearance of companion diagnostics. According to FDA, this guidance...

Direct Flow Medical’s TAVI Technology Receives Additional CE Mark

August 22, 2014 1:37 pm | by Direct Flow Medical | News | Comments

Direct Flow Medical, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has received the CE Mark (Conformité Européenne) for a 23mm sized valve as part of its Direct Flow Medical Transcatheter...

Ultrasound-Based Wound Healing System Receives FDA Clearance

August 21, 2014 10:12 am | by PR Newswire | News | Comments

Celleration, Inc., a privately held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies to treat wounds, has announced they received FDA clearance for their next generation UltraMIST...

FDA 510(k) Clearance for Philips' TAVI Precision Treatment Planning Application

August 21, 2014 10:03 am | by PR Newswire | News | Comments

Royal Philips today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments. Through 3D imaging, the...

First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device

August 21, 2014 10:01 am | by PR Newswire | News | Comments

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor's automated analysis...

Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

August 20, 2014 2:03 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Section 907 of the...

Providing Easy Access to Medical Device Reports Submitted to FDA Since the Early 1990s

August 19, 2014 2:06 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA and Jeffrey Shuren, M.D., Director – CDRH, FDA | Blogs | Comments

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential...

3D Printed Patient-Specific Facial Device Receives FDA Clearance

August 19, 2014 11:26 am | by Globe Newswire | News | Comments

Oxford Performance Materials, Inc., a leading advanced materials and additive manufacturing (3D printing) company, has announced that it has received 510(k) clearance from the FDA for its 3D printed OsteoFab Patient-Specific Facial Device...

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading