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Blog: Test & Measurement
Fighting the Opioid Crisis: Researchers Present Breakthrough Tool in Upcoming Webinar
“Opioid abuse, misuse, and addiction has become one of the most profound public health crises facing the U.S. today,” says Jeffrey Shuren, FDA, CDRH. The agency, along with many others, are scrambling to find ways to confront the crisis.
One challenge is the...
Blog: Design
Latest Patent Trends Favor Patentees — What Device Makers Need to Know
Medical device companies have challenged thousands of patents using the Patent Trial and Appeal Board’s (PTAB) administrative adjudication system. Introduced in 2012, PTAB provides an alternative to bringing much more expensive and time-consuming patent lawsuits in federal...
From the Editor: Medical
From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase
The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the lessons it has learned to date. The program aims to “reimagine” how FDA regulates digital health devices,...
From the Editor: Regulations/Standards
In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of...
From the Editor: Medical
Political uncertainty will be the biggest factor that could upend healthcare transactions according to a recent Merrill InsightTM poll of global mergers and acquisitions...
From the Editor: Design
From the Editor — Permanently Repealing the Device Tax to Protect Medical Innovation
A new house bill is set to end the medical device tax once and for all. H.R. 2207 was introduced in April — it’s goal to permanently repeal the medical device excise tax that was imposed as a provision of the Affordable Care Act in 2010.
From the Editor: Regulations/Standards
From the Editor — Spurring Innovation of Brain-Computer Interface Devices
Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often referred to as brain-computer interface devices — that can help patients with paralysis or amputation gain...
Blog: Manufacturing & Prototyping
Under tremendous pressure to reduce costs, the healthcare industry is facing a monumental shift in how providers are reimbursed for delivering care....
From the Editor: Regulations/Standards
When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process for...
From the Editor: Connectivity
Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But...
From the Editor: Connectivity
The IoMT has ushered in a new era for connected medical technology. But battery life is often mentioned as one of the impediments to the...
Blog: Medical
An increase in the incidence of vascular disorders, blockage of blood vessels, and high blood sugar has led to a rise in usage of vascular grafts for treatment....
From the Editor: Medical
With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules...
From the Editor: Medical
In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and...
From the Editor: Regulations/Standards
Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid crisis.
From the Editor: Medical
New research has confirmed what device companies have been saying since the medical device excise tax was imposed on medical devices as part of the Affordable Care Act:...
From the Editor: Medical
The medical device industry’s active M&A market and uncrowded investment space make it attractive for investors looking to get...
From the Editor: Medical
I am truly excited about this month’s inaugural MedInnovation conference. It’s goal is to present a roadmap for getting innovative — and by that, I mean game changing...
From the Editor: Software
A virtual reality system for training surgeons is gaining traction with major medical device companies looking to mitigate misuse and liability concerns.
From the Editor: Medical
A new interactive conference will address key strategies for the commercialization of emerging medical technologies, and its unique...
From the Editor: Motion Control
In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design...
From the Editor: Manufacturing & Prototyping
FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant...
From the Editor: Medical
The integration of robotics into medical devices has seen explosive growth in recent years with new applications in areas such as prosthetics and rehabilitation,...
From the Editor: Medical
FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 20 years of use, manufacturers of devices...
From the Editor: Medical
In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the...
From the Editor: AR/AI
The Future of Medical Manufacturing implementing automation. It is embracing 3D printing, Industry 4.0, the Internet of Things, artificial intelligence (AI), and even augmented reality —...
From the Editor: Medical
Medtech M&A on the Rise Again
It appears that the medtech industry has responded to a healthier market by going on a shopping spree. According to EP Vantage, a service of market analysis firm Evaluate, medtech mergers are back. EP says that the sum spent on deals in the first half of 2017 has already surpassed last year’s total, “putting 2017...
From the Editor: Medical
MedAccred Makes Its Mark
The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.
From the Editor: Connectivity
Your Cyberattack Wake-Up Call
We’ve been hacked. Forbes reports that the WannaCry ransomware did, in fact, infect a Bayer Medrad radiology power injector in U.S. hospitals. Thankfully, no safety-related functions were affected directly, but what about next time?
Top Stories
INSIDER: Sensors/Data Acquisition
Tiny Sensor Could Transform Head Injury Detection
News: Robotics, Automation & Control
Quantum Surgical Acquires NeuWave Medical, Inc.
Briefs: Materials
Shrinking Materials Hold Big Potential for Smart Devices
Podcasts: Medical
The Hidden Nervous System of Surgical Robotics: Power, Data & Sensing...
Briefs: Medical
Specialty Thermoplastics for Medical Tubing Address PFAS, Processing, and...
Podcasts: Medical
Ask the Expert
Eric Dietsch on the Benefits of Nitinol Wire
In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.
Webcasts
Podcasts: Design
The Hidden Nervous System of Surgical Robotics: Power, Data & Sensing Behind...
Podcasts: Medical
Surgical & Assistive Robotics: Redefining Human Capability
Podcasts: Medical
How Wearables Are Enhancing Smart Drug Delivery
Podcasts: Design
Developing Sustainable Drug-Delivery Devices
Podcasts: Medical
Smarter Pathways for Precision Drug Delivery in Cancer Care
On-Demand Webinars: Manufacturing & Prototyping
Understanding Testing and Compliance Requirements for Wireless Medical Devices
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.
