Stories
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Features: Wearables
The COVID-19 pandemic has ushered in a new period of growth for wearables.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Products: Regulations/Standards
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
From the Editor: Design
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
Applications: Regulations/Standards
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
Features: IoMT
As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...
Blog: Medical
Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process with...
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Medical
FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production of...
Blog: Medical
The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...
From the Editor: Regulations/Standards
FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Blog: Regulations/Standards
The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA pathway,...
Blog: Regulations/Standards
FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...
From the Editor: Regulations/Standards
FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...
From the Editor: Medical
As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the...
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,...
Features: Data Acquisition
Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier (UDI)...
Features: Medical
Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...
Briefs: Software
While the regulatory and validation burden can be high, it's not surprising that the medical device industry is one of the earliest adopters of additive manufacturing (AM, aka 3D...
Features: Software
Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This includes...
From the Editor: Medical
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: 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...
News: Regulations/Standards
FDA to Address New “Quik” Review Program Pilot for Faster Review of Certain 510(k)s
On October 10, 2018, FDA will host a webinar to share information and answer questions about the Quality in 510(k) (“Quik”) Review Program pilot. More information about the webinar is available here. On September 6, FDA launched the “Quik” Review Program...
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.
News: Regulations/Standards
The Food and Drug Administration (FDA) has announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C...
News: Regulations/Standards
FDA Launches Innovation Challenge for Devices to Prevent and Treat Opioid Use
FDA has launched an innovation challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder — a serious health condition that can be a...
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...
News: Communications
FDA Touts New AAMI Report on ‘Wireless Coexistence’ and Medical Devices
The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.
R&D: Medical
FDA-Approved Algorithm Detects Hemorrhagic Shock
Researchers from the U.S. Army Institute of Surgical Research collaborated with scientists and engineers at the University of Colorado and Flashback Technologies, Inc., to develop an algorithm, the Compensatory Reserve Index (CRI), to detect when a patient experiences hemorrhagic shock, a leading...
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.
