Stories
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Features: Medical
When science and nature combine in just the right amounts, the results can be astounding. Take transdermal drug delivery, which is expected to grow substantially in...
Features: Medical
Implementation of IEC 60601-1-2, 4th edition is on the horizon. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for medical...
From the Editor: Design
Good News/Sad News
For much of our recent Editorial & Sales Meeting, we discussed trends that we are seeing in the marketplace, in the news, and in discussion with contributors to evaluate coverage for this year and to help sharpen our editorial focus for next year. Manufacturing will continue to see greater coverage as we increase the...
INSIDER: Regulations/Standards
UL and VA Sign CRADA for Medical Device Cybersecurity Standards
The U.S. Department of Veteran Affairs (VA), Washington, DC, and UL (Underwriters Laboratories), Northbrook, IL, a global safety science organization, have signed a Cooperative Research and Development Agreement (CRADA) for current and emerging medical devices cybersecurity standards...
INSIDER: Electronics & Computers
Diabetes Technology Society Develops Cybersecurity Standard for Devices
The Diabetes Technology Society recently announced its new cybersecurity standard for interconnected diabetes devices called DTSec. The standard specifies performance requirements utilizing the ISO/IEC 15408 framework used to define security requirements on “smart” medical...
Briefs: Medical
A team of electrical, computer, and mechanical engineering students at Rice University, calling itself Carpal Diem, has developed a testing suite to validate how well 3D-printed prosthetic hands transfer...
INSIDER: Manufacturing & Prototyping
A masters student in product development at the School of Engineering at Lund University, Sweden, Emelie Strömshed,has developed a step-by-step process to combine prosthetic arm socket...
Global Innovations: Medical
National University of Singapore, Singapore
http://news.nus.edu.sg/
Patients who have lost their function in their hand due to injury or a nerve-related condition, such as stroke or muscular...
Briefs: Manufacturing & Prototyping
Researchers at the National Institute of Standards and Technology (NIST) say that manufacturers may soon have a speedy and nondestructive way to test a wide array of materials under real-world...
Technology Leaders: Materials
TECHNOLOGY LEADERS: Materials/Coatings/Adhesives
According to the United Nations Department of Economic and Social...
Features: Test & Measurement
Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility tests...
From the Editor: Medical
By the time you read this, Robert M. Califf, MD, a recognized global leader in cardiology, clinical research, and medical economics, will have been installed as the U.S. Food and Drug Administration’s...
Features: Design
Interventional cardiology is one of the most dynamic medical device markets, witnessing a surge in new product development with accompanying mergers,...
INSIDER: Regulations/Standards
The International Organization for Standardization (ISO), Geneva, Switzerland, late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management...
INSIDER: Medical
The FDA is seeking comments from the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices.
INSIDER: Medical
Dr. Robert M. Califf, a cardiologist, researcher, and founder of the Duke Clinical Research Institute, was confirmed by the Senate on February 24 as the next Commissioner of the U.S. Food and Administration...
Briefs: Medical
In a first for the field of upper limb prosthetics, a pioneering surgical technique has allowed an amputee to attach a Modular Prosthetic Limb (MPL) developed by researchers at the...
Features: Regulations/Standards
Some of the biggest stumbling blocks encountered by medical device firms on the way to clearance or approval of their devices by the U.S. Food and Drug...
Features: Medical
When it comes to medical equipment, nothing is more important than the safety of patients and health care personnel. From diagnostic tools such as ultrasound devices to home health...
From the Editor: Medical
Ch-Ch-Ch-Changes
According to the late, great David Bowie, “the stars look very different today”. After two years of collecting the 2.3% Medical Device Excise Tax, the tax has now been suspended for all of 2016 and 2017 when President Obama signed the Consolidated Appropriations Act of 2016. The tax was expected to raise almost $30 billion over...
Briefs: Medical
While trips and stumbles leading to falls can be common for amputees using leg prosthetics, a new robotic leg prosthesis being developed at Carnegie Mellon University promises to help users recover their...
INSIDER: Connectivity
Cybersecurity threats to medical devices are a growing concern that present a potential risk to the safety and effectiveness of medical devices. To address this, the FDA has issued...
INSIDER: Medical
In a draft guidance for industry and staff issued on December 31, the FDA proposed notifying the public about medical device “emerging signals that the agency is monitoring or analyzing,...
Products: Test & Measurement
Advanced Orientation Systems, Inc., Linden, NJ, has released the wireless EZ-LEVEL-PRO dual axis inclinometer suitable for laboratory, QC, or high-resolution production applications and allows users to perform...
INSIDER: Medical
FDA Announces Training Program for Medtech Reviewers
The FDA’s Center for Devices and Radiological Health (CDRH) announced the 2015 Experiential Learning Program (ELP) General Training Program, which is intended to educate CDRH staff regarding the policies, laboratory practices, and challenges faced in broader disciplines that impact the medical...
R&D: Medical
Flexible Rehealing Glove Treats Traumatic Hand Injuries
Engineers at the University of Texas at Arlington Research Institute (Fort Worth, TX) and The University of Washington (Seattle, WA) have developed a healing glove that delivers needed medicine to an injured hand. The device, known as the Bioengineered Smart-Glove for Regenerative Healing of...
Products: Manufacturing & Prototyping
Microsemi Corporation, Aliso Viejo, CA, announces the availability of the smallest radio module it has ever produced. The ZL70323 is optimized for implantable medical devices...
INSIDER: Medical
IEEE Advances Standards and Works to Expand Interoperable eHealth Communications
IEEE, Piscataway, NJ, has announced a new standard and two new standards development projects designed to support plug-and-play, interoperable communications across eHealth devices. The new eHealth standard is IEEE 2410™-2015, Biometrics Open Protocol Standard,...
Technology Leaders: Medical
The results of recent surveys suggest that more than half of all healthcare decisions are made using test results obtained from medical diagnostic instrumentation. These tests are...
Top Stories
INSIDER: Medical
Brain Implant Enables Safer Drug Delivery
Features: Medical
Built to Adapt: Rethinking Contract Manufacturing for a New Era
Podcasts: Design
Smarter Pathways for Precision Drug Delivery in Cancer Care
From the Editor: Medical
From The Editor: Charting the Technologies That Will Shape Medtech in 2026
Features: Materials
OEM Toll Processing Advances High-Value Products
Podcasts: Medical
Ask the Expert
Ralph Bright on the Power of Power Cords
Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.
Webcasts
Podcasts: Medical
How Wearables Are Enhancing Smart Drug Delivery
Podcasts: Design
Developing Sustainable Drug-Delivery Devices
Podcasts: Design
Smarter Pathways for Precision Drug Delivery in Cancer Care
On-Demand Webinars: Medical
Understanding Testing and Compliance Requirements for Wireless Medical Devices
Podcasts: AR/AI
Personalized Medicine and Drug Delivery
Podcasts: Manufacturing & Prototyping
Inside Story
Inside Story: Trends in Packaging and Sterilization
Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.
