Advertisement
Regulatory
Subscribe to Regulatory

The Lead

Reality Check: Wearables Impact on the Medical Device Industry

June 2, 2015 10:35 am | by Bill Betten, VP of Business Solutions, Logic PD | Blogs | Comments

Wearable technology has been on a rapid growth curve over the last few years, with some projections suggesting that the revenue will increase from $14 Billion in 2014 to $70 Billion by 2025. Wearables are appearing in a variety of applications...

FDA Approves Brain Vessel Stroke Clot 'Vacuum'

June 1, 2015 11:51 am | by Penumbra Inc. | News | Comments

Penumbra Inc., a global interventional therapies company and innovator in intra-arterial stroke...

Designing for the End-User: Human Factors Engineering

May 29, 2015 10:57 am | by Myles Whiting, Design Team Leader, Product Design; Gareth Walker, Human Factors Specialist; Owen Mumford | Articles | Comments

Advances in today’s pharmaceutical market constantly impact the way medical equipment is both...

FDA Approves Emergency Use of Ebola Diagnostic Test

May 29, 2015 9:55 am | by Lawrence Livermore National Laboratory | News | Comments

Researchers from LLNL and three other institutions have assisted a Bay Area biomedical company...

View Sample

FREE Email Newsletter

Can ‘Do It Yourself’ MedTech Inspire Innovation?

May 28, 2015 11:56 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Blogs | Comments

The problem is that while many of these makers developing technologies in their garages and basements were technically savvy, they were not overly familiar with critical areas such as biocompatibility, powering implants, or similar factors...

Congressional Action Needed to Optimize Genomic Test Regulation

May 28, 2015 9:03 am | by University of Washington Health Sciences/UW Medicine | News | Comments

The latest generation of genomic testing offers a chance for significant improvements in patient care, disease prevention, and possibly even the cost-effectiveness of healthcare. A new report recommends that Congress act to incentivize the...

3D Printed Anatomy Kit for Medical Students

May 27, 2015 9:12 am | by Monash University | News | Comments

A unique kit containing anatomical body parts produced by 3D printing is now available for medical students to use worldwide. The kit, developed by Monash University scientists, is the first commercially available resource of its kind. The team...

Advertisement

Hackers Will Try to Penetrate Connected Devices

May 27, 2015 8:41 am | by Alan Grau, President, Icon Labs | Blogs | Comments

The inherent insecurity of many medical devices was highlighted in a recent FDA and Homeland Security alert. Over 300 devices have been identified that utilize a hard code password creating a huge security loophole. This is akin to putting a safe...

5 Questions to Help Navigate Intellectual Property

May 26, 2015 11:09 am | by Ticora E. Davis, Esq., Intellectual Property Analyst, Edison Nation Medical | Blogs | Comments

Whether you work full-time developing new healthcare advances or are simply a person with a fresh, new perspective on how to deliver better patient care, conceptualizing an innovative healthcare solution is an exciting first step in the journey to...

Address Security and EMC Compliance in Your Connected Device

May 22, 2015 8:49 am | by Nicholas Abbondante, Chief Engineer for EMC, Intertek | Blogs | Comments

It’s increasingly critical to ensure that connected medical devices are tested and evaluated to reduce electromagnetic interference (EMI) and to ensure electromagnetic compatibility (EMC) compliance. One aspect of this is co-existence testing...

FDA Panel Acknowledges Safety Risk with Duodenoscope Reprocessing

May 20, 2015 3:28 pm | by AAMI | News | Comments

A U.S. Food and Drug Administration (FDA) advisory panel has determined that current methods for cleaning and disinfecting a complex type of endoscope do not provide a reasonable assurance of safety and effectiveness. To tackle the problem...

Module Suppliers Should Be Viewed as Long-Term Partners

May 19, 2015 8:50 am | by Mike Rohrmoser, Senior Product Manager, Embedded Solutions, Digi International Inc. | Blogs | Comments

The ever-growing number of connected medical devices is driving significant benefits that are directly impacting many aspects of healthcare including clinical outcomes, patient safety, treatment cost, and record accuracy. Most of today's...

Advertisement

Beware FDA 'Approved' Robotic Prostatectomy Care

May 18, 2015 1:24 pm | by PR Newswire | News | Comments

A South Florida-based urologist today has issued a stinging report critical of the Food and Drug Administration (FDA) decision to approve robotic surgery for treating prostate cancer on the basis of only some low-level and irrelevant...

FDA Website Tracks IDs of Medical Devices

May 18, 2015 10:58 am | by Dave Taylor, VP Product Strategy, PRISYM ID | Blogs | Comments

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But the latest FDA announcement that its online Global Unique Device Identification Database, AccessGUDID, is now available...

4 Steps to GHS Compliance

May 15, 2015 12:17 pm | by Nick Recht, Enterprise Product Manager, TEKLYNX Americas | Articles | Comments

In the chemical industry, safety is of the utmost importance. The Occupational Safety & Health Administration (OSHA) estimates that over 43 million employees in the United States could be exposed to hazardous chemicals. Implementing appropriate...

World's Smallest Pacemaker Initially Proven Safe and Effective

May 15, 2015 9:34 am | by Heart Rhythm Society | News | Comments

The first-in-human trial of a new miniaturized leadless pacemaker implanted directly inside the heart found that the transcatheter pacing system (TPS) can be safely and effectively applied in patients with a slow heart rhythm. Early performance...

UDI: Market Movement Signifies Increased Use and Value

May 14, 2015 11:02 am | by Karen Conway, Executive Director, Industry Relations, GHX | Articles | Comments

The U.S. FDA UDI rule took the stage at the annual HIMSS conference. But this time the attention was not on manufacturers, many of who are still working fast and furiously to meet upcoming compliance deadlines. Rather, the focus was on their...

Advertisement

Cybersecurity and the Artificial Pancreas: What Are the Risks?

May 13, 2015 1:12 pm | by Mary Ann Liebert, Inc., Publishers | News | Comments

An artificial pancreas, designed for blood glucose control in diabetes, is controlled by software that runs on mobile computing platforms such as laptops, tablets, and smartphones, and operates over wireless networks under local or remote medical...

FDA Pulls 'Outdated' Draft Guidance Documents

May 13, 2015 9:32 am | by AAMI | News | Comments

In what it calls a move to improve the efficiency and transparency of the guidance development process, the U.S. Food and Drug Administration (FDA) is withdrawing 47 draft guidance documents that were published before Dec. 31, 2013 and never...

Custom Bearings: 4 Advantages for Your Design

May 12, 2015 11:19 am | by Mark Bos, VP of Business Development, National Bearings | Articles | Comments

Standard bearings are made from standard materials. Chrome steel bearings are subject to corrosion and the design will be complicated by the necessity of protecting the bearing from contamination. Stainless steel bearings are made from 440C...

Exoskeleton that Helps Paralyzed Walk Faces Barrier in Japan

May 12, 2015 9:49 am | by Yuri Kageyama, AP Business Writer | News | Comments

Yuichi Imahata's 9-year-old daughter is thrilled her dad stands tall above her head. It's an experience that is new to her. Imahata, 31, has been using a wheelchair to get around for seven years after a serious spinal-cord injury suffered...

Find the Connected Medical Device 'Cost-Performance Balance'

May 12, 2015 8:30 am | by Tom Medina, Senior Principal Engineer, TE Connectivity | Blogs | Comments

Medical Device OEM customers are seeking a solution that helps them deliver a higher standard of care for better patient outcomes. They may need an improvement in performance or an expansion of function. To meet the needs of an emerging market...

FDA Approves Non-Tingling Spinal Cord Stimulation System

May 11, 2015 9:51 am | by U.S. Food & Drug Administration | News | Comments

Today [8 May] U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back...

April/May 2015 Digital Edition

May 8, 2015 4:02 pm | by MDT Staff | Digital Editions | Comments

This issue's articles cover an elegant delivery solution for dispensing unit-of-use reagents for POC medical diagnostic devices, the advantages of custom bearing design, six mantras for medical device manufacturers, design considerations for integrated drug delivery systems, technology's battle against cancer, a roundtable discussion on developing the vasculature of medical devices, and aspects of packaging design for the mindful engineer.

Hacking a Teleoperated Surgical Robot to Reveal Security Flaws

May 7, 2015 3:39 pm | by University of Washington | News | Comments

To make cars as safe as possible, we crash them into walls to pinpoint weaknesses and better protect the people who use them. That's the idea behind a series of experiments conducted by a University of Washington engineering team who hacked a...

FDA Opens Up Access to UDI Database

May 7, 2015 9:24 am | by AAMI | News | Comments

As part of efforts to keep track of devices throughout the supply chain, the U.S. Food and Drug Administration (FDA) has teamed up with the National Institutes of Health's National Library of Medicine to make data on unique device identifiers...

FDA Science Forum to Focus on Emerging Technologies

May 6, 2015 4:02 pm | by FDA Voice | Videos | Comments

Dr. Luciana Borio, FDA’s Acting Chief Scientist, invites you to the FDA 2015 Science Forum at our White Oak headquarters in Silver Spring, Maryland on May 27-28. We’ll be showcasing exciting, cutting-edge regulatory science research. For more information...

5 Ways to Build Proactive Preventive Maintenance Programs

May 6, 2015 10:22 am | by Joanna Rotter, Content Marketing Manager, MSI Data | Blogs | Comments

As technology advancements improve visibility into medical equipment performance, equipment manufacturers have found that customer expectations are also rising. Customers expect more than just a piece of equipment. Now they want strong service...

Clamping Down on Harmful Harmonics

May 5, 2015 10:18 am | by Steve Hughes, Managing Director, REO UK | Articles | Comments

It seems that human-kind has an insatiable appetite to dominate every aspect of our environment. At home, in the car or at the office, we demand complete control. Innovations in medical technology (MedTech) are helping us to achieve this and...

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