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FDA Enters Consent Decree with Medtronic

April 28, 2015 8:38 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the...

We Should Be Ashamed of Lowering Standards

April 28, 2015 8:30 am | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Blogs | Comments

As higher education appears to be at a perilous tipping point in terms of creating quality,...

Case Closed: Diagnosing on Mobile Devices Requires FDA Class II Clearance

April 27, 2015 2:55 pm | by Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific | Blogs | Comments

This February the FDA released updated guidance on mobile medical applications for the first...

Neurostimulator Granted European Approval for Full Body MRI Scans

April 27, 2015 11:02 am | by Medtronic | News | Comments

Medtronic plc announced that systems within its Activa portfolio of Deep Brain Stimulation (DBS...

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Senate Hearing on Medical Device Tax Effects

April 24, 2015 10:46 am | by The Medical Imaging & Technology Alliance (MITA) | News | Comments

The Medical Imaging & Technology Alliance (MITA) commends the U.S. Senate Committee on Finance Subcommittee on Health Care for convening today’s hearing, “A Fresh Look at the Impact of the Medical Device Tax on Jobs, Innovation, and Patients...

Inflatable Penile Prosthesis FDA Approved for Ectopic Placement

April 24, 2015 10:41 am | by PR Newswire | News | Comments

Coloplast, a leading medical device company, announced it has received approval from The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for changes in labeling of the Titan Inflatable Penile Prosthesis...

Might Consumer and MedTech Collaborations Win the Day?

April 23, 2015 2:31 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Blogs | Comments

While the traditional medical device OEMs are still focused on improving technologies and making healthcare devices more effective and efficient, they seem to be mired in a world of incremental innovation. Meanwhile, grabbing headlines and...

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FDA Holds Public Meeting on Postmarket Risk for Medical Devices

April 23, 2015 10:06 am | by AAMI | News | Comments

How can the medical device industry best manage risk when it comes to products that are already on the market and in use in hospitals and other healthcare facilities? That was the focus of a public workshop Tuesday organized and hosted by the...

Anesthesia Workstations: Is Monitoring Affecting Product Choice?

April 22, 2015 11:16 am | by Jessica Edge, Analyst, Clinical Care Devices, IHS Medical Technology | Blogs | Comments

The market for anesthesia devices is largely divided into stand-alone anesthesia machines and anesthesia workstations (those sold with a patient monitor of the same brand). Stand-alone anesthesia machines leave the manufacturer without a patient...

FDA Draft Guidance on the Acceptance of Medical Device Clinical Data

April 22, 2015 9:11 am | by U.S. Food & Drug Administration | News | Comments

Today the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically...

Blue Man Group Lends a Hand to MedTech Design

April 21, 2015 11:10 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Blogs | Comments

Not long ago, Robert Downey Jr. (or Tony Stark…or Ironman) helped deliver a bionic arm to a young boy, Alex Pring. It was a great “feel-good” story and the boy seemed pretty pleased with his new prosthetic. Then, earlier this month, Blue Man Group...

FDA Approves First-of-Its-Kind Corneal Implant

April 21, 2015 9:22 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for...

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Compendium Tackles Challenge of Medical Device Integration

April 20, 2015 12:51 pm | by AAMI | News | Comments

Do you have questions about connecting medical devices and electronic health records (EHRs)? A comprehensive compendium from AAMI could help provide the answers. Medical Device Integration and Informatics (PDF) by Luis Melendez covers the...

FDA Approves Over-the-Counter Blood Glucose Meter

April 17, 2015 2:27 pm | by Abbott Laboratories | News | Comments

The cost of insurance premiums and employee medical claims continues to rise in the United States, which is especially challenging for people living with chronic conditions such as diabetes. For people with diagnosed diabetes, average, direct...

FDA and CMS Form Task Force on LDT Quality Requirements

April 17, 2015 12:15 pm | by Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc | Blogs | Comments

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality. Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs)...

FDA Finalizes Program to Speed Access to Devices for Gravely Ill Patients

April 15, 2015 10:02 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) has introduced a program intended to give gravely ill patients earlier access to certain high-risk devices. Designed to help those with conditions for which no treatments exist, or that are serious...

World's Smallest Pacemaker Receives CE Mark

April 14, 2015 10:54 am | by Medtronic | News | Comments

Medtronic plc today announced it has received CE (Conformité Européenne) Mark of the Micra Transcatheter Pacing System (TPS), the world's smallest pacemaker. At less than one-tenth the size of traditional pacemakers, the Micra device provides...

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3 Keys to Medical Device Development Excellence

April 13, 2015 11:29 am | by Mohan Ponnudurai, Industry Solution Director, Sparta Systems, Inc. | Articles | Comments

Some of the future-looking technological developments in medicine, including surgeries enabled by virtual reality, remote surgery, needle free treatments and even electronic aspirin, all have the same mission in mind – to deliver the highest level...

Developing a Do-It-Yourself-Pancreas

April 10, 2015 8:30 am | by Charles Settles, Product Analyst, TechnologyAdvice | Blogs | Comments

Diabetes, the seventh leading cause of death in the U.S., receives the 37th-most research funding, according to the NIH. Seeing little progress, some diabetics are taking matters into their own hands. Health IT is one of the fastest growing...

Providing Timely Patient Access to High-Quality, Safe and Effective Medical Devices

April 9, 2015 11:19 am | by Jeffrey Shuren, M.D., J.D. | Blogs | Comments

We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may...

Top 10 Patient Safety Concerns for Healthcare Organizations

April 7, 2015 8:54 am | by ECRI Institute | News | Comments

Patient safety is a top priority for every healthcare organization, but knowing where to direct initiatives can be daunting. To help organizations decide where to focus their efforts, ECRI Institute has compiled its second annual list of the...

EMR and EHR: Orienting the Focus

April 7, 2015 8:30 am | by Zev Ginzburg, UX Researcher & Copywriter, Codal Inc. | Blogs | Comments

The EHR and EMR mandates in the Patient Protection and Affordable Health Care Act (PPACA) provisions in conjunction with the Health Information Technology for Economic and Clinical Health Act (HITECH) create noticeable fiscal incentives...

Medical Device Maker Settles Lawsuit for $4.4 Million

April 6, 2015 10:24 am | by The Associated Press | News | Comments

Medtronic has agreed to pay $4.4 million to settle a lawsuit filed by the federal government accusing the company of selling medical devices made in China and Malaysia to the U.S. military. Federal law requires that devices sold to the military...

Achieving UDI Compliance & Reducing Print Time

April 2, 2015 3:40 pm | by Josh Roffman, Vice President of Marketing & Product Management, Loftware | Articles | Comments

Founded more than 30 years ago in Switzerland, EMS Electro Medical Systems is a manufacturer of micromechanical instruments. Specializing in the design and development of orthopedic, urological and dental prophylaxis devices, the company...

3 Tips for Managing Your Medical Device Design History File

March 31, 2015 8:30 am | by Jon Speer, Co-Founder & VP of QA/RA, greenlight.guru | Blogs | Comments

Developing a cutting edge medical device can be really fun and exciting. There’s always something to test and do and learn from. You have that great feeling you’re changing the world. Documenting the development of a medical device isn't fun...

FDA Approves Blood Pump System for High-Risk Cardiac Procedures

March 28, 2015 8:30 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention...

Organ Printing, Regulation in the Spotlight on MDT Live

March 27, 2015 3:39 pm | by Megan Crouse, Real Time Digital Reporter, @abmdigi | Articles | Comments

3D printing for medical devices is still a wild frontier without thorough regulation, which can both make building a product difficult and can spur innovation. Three experts sat down with Editor-in-Chief Sean Fenske this week to talk about...

Laws That Kill Innovation Will Ultimately Kill People

March 27, 2015 2:02 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Blogs | Comments

February 2014 can be defined by updated DFA proposals supporting updated standards specific to blood glucose monitor accuracy standards for devices used in both home consumer and healthcare facilities. Twelve months later, February 2015 is...

Maker of Tainted Medical Scopes Issues New Cleaning Guide

March 27, 2015 1:40 pm | by The Associated Press | News | Comments

The maker of medical scopes that have been linked to two recent "superbug" outbreaks at California hospitals has issued new cleaning instructions for the devices amid scrutiny from regulators, lawmakers and medical professionals. Olympus...

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