Stories
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Briefs: Regulations/Standards
The FDA has taken a substantial step in its digital modernization strategy with the deployment of agentic AI capabilities across all agency employee groups. The move represents an expansion of the agency’s internal AI tools, intended to streamline complex, multi-step processes that support regulatory science, product review, and compliance activities. Read on to learn more.
From the Editor: Regulations/Standards
"If regulators are accelerating their digital transformation, the medtech community must be ready to meet them there." Read more about Editor and Director of Medical Content Sherrie Trigg's opinion in From the Editor.
Products: Connectivity
See the new products and services, including Syensqo's medical-grade polyphthalamide; non-PFAS low-retention additives for pipette tips from Avient; Binder's expanded M8 connector portfolio; fiber laser marking systems for UDI and traceability codes from FOBA; and more.
Trivia: Regulations/Standards
What wearable medical device uses tumor-treating fields delivered through adhesive transducer arrays to treat advanced non-small cell lung cancer?
Trivia: Regulations/Standards
What consumer technology device became the first FDA-approved over-the-counter (OTC) assistive hearing device for adults with mild to moderate hearing loss?
Products: Regulations/Standards
See the product of the month: MethodSense's Elsa & AI Resource Center at MethodSense.com. Read on to learn more about it.
Features: Connectivity
The regulatory and testing landscape for medical devices is shifting in real time. Standards are being revised. Read on to learn what this means.
Trivia: Regulations/Standards
In May 2004, FDA issued a guidance document that reclassified certain dental implants from Class III to Class II, thereby reducing regulatory burdens while maintaining safety standards. What type of dental implants were...
Briefs: Regulations/Standards
FDA Approves Final MDIC Report on MedAccred’s Sterilization Audit and Accreditation Program
MedAccred is an industry-managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. The MedAccred program is administered by PRI and governed by the original equipment manufacturer (OEM) subscribers who define program requirements, review audit reports, and accept non-conformance resolutions. Read on to learn more.
Features: Wearables
Read on to learn more about a significant step forward in the rapidly evolving field of digital therapeutics (DTx).
News: Regulations/Standards
In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of...
From the Editor: Medical
Hear directly from Sherrie Trigg, Editor and Director of Medical Content, about the FDA's final ruling on LDTs and why that is raising concern.
Blog: Medical
Recently, I came across an FDA regulatory situation you do not see too often. On the same day, FDA sent two teams of field investigators into two geographically different sites of the same company to...
Trivia: Regulations/Standards
What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?
Podcasts: Manufacturing & Prototyping
In this season, we are taking an in-depth look at Printed Health: Transforming Medicine with Advanced Manufacturing, and this episode will focus specifically on...
From the Editor: Medical
At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery performance information included in applications and submissions. Read on to learn more about it.
INSIDER: Regulations/Standards
On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.
From the Editor: Regulations/Standards
Analytics firm GlobalData has weighed in on the U.S. FDA's proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change.
News: Regulations/Standards
MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from...
Blog: Regulations/Standards
Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.
News: Medical
The U.S. Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to...
Briefs: Packaging & Sterilization
The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.
News: Regulations/Standards
The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine others. The catalog is a peer-reviewed resource...
Supplements: Test & Measurement
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
News: Medical
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...
Features: Design
The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering.
News: Regulations/Standards
Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...
Supplements: Test & Measurement
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Features: Government
Medical device manufacturers face constant changes coming from both internal and external sources.
Top Stories
INSIDER: Materials
Hydrogels: The Future of Bone Implants
INSIDER: Medical
Adaptable Drug-Delivery Platform Accelerates Next-Gen Medicine
Briefs: Wearables
Sweat-Powered Sticker Turns Drinking Cup Into a Health Sensor
Features: Medical
Inside the OEM: Intuitive’s Next Chapter — Scaling Robotics, Data, and...
Briefs: Medical
AI-Generated Sensors Open New Paths for Early Cancer Detection
Features: Medical
A Material Difference: Engineering Smaller Medical Devices at the...
Ask the Expert
Dan Sanchez on How to Improve Extruded Components
Improving extruded components requires careful attention to a number of factors, including dimensional tolerance, material selection, and processing. Trelleborg’s Dan Sanchez provides detailed insights into each of these considerations to help you advance your device innovations while reducing costs and speeding time to market.
Webcasts
Editorial Webinars: Medical
Next-Generation Materials for Medical Devices: From Smart Polymers to...
Podcasts: Medical
How Tissue-Based Approaches Are Enabling Long-Term Implants
Podcasts: Medical
Training the Future of AI-Powered Surgery
Podcasts: Robotics, Automation & Control
Making Human-Centered Robotics Work in the Real World
Podcasts: Robotics, Automation & Control
The Hidden Nervous System of Surgical Robotics: Power, Data & Sensing Behind...
Podcasts: Medical
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.
