Login
Join
FOLLOW:
Subscribe Free
Magazine
eNewsletter
Checkout
Menu
Magazine
News
Opinions
Top 30
Research
Supply Chain
Device Sectors
Directory
Events
Resources
Microsites
More
Magazine
News
Opinions
Top 30
Research
Supply Chain
Device Sectors
Directory
Events
Resources
Microsites
Current / Back Issues
Features
Editorial
Digital Edition
eNewsletter Archive
Our Team
Editorial Guidelines
Reprints
Subscribe Now
Advertise Now
Top Features
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Supplying Sustainable Surfaces for Medical Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
OEM News
Supplier News
Service / Press Releases
Online Exclusives
Press Releases
People in the News
Product & Service Releases
Supplier News
Medtech Makers
Technical Features
International News
Videos
Product & Service Releases
Live From Shows
Regulatory
Financial/Business
Top News
Reprieve Cardiovascular Emerges From Stealth Mode With $42M Financing
Wearable Neuromodulation System for Urinary Incontinence Makes its Debut
Clinical Data Support Early Detection Ability of IR-MED's Pressure Injury Device
FineHeart Widens FlowMaker's International IP Protection
Encore Medical Device Repair Introduces Robotic Remanufacturing and Sustainability Program at HSPA
From the Editor
Blogs
Guest Opinions
Top Opinions
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Supplying Sustainable Surfaces for Medical Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
Top 30 Medical Device Companies
Market Data
White Papers
Top Research
Competition Bolsters Pediatric Device Innovation
Discovering and Reducing Your Device’s Carbon Footprint
Medical Device Design Verification: Teamwork Makes the Dream Work
Workforce Benefits from the AI Transformation
Potential Hidden Dangers of Coatings on Limited-Duration Devices
3D/Additive Manufacturing
Contract Manufacturing
Electronics
Machining & Laser Processing
Materials
Molding
Packaging & Sterilization
R&D & Design
Software & IT
Testing
Tubing & Extrusion
Cardiovascular
Diagnostics
Digital Health
Neurological
Patient Monitoring
Surgical
Orthopedics
All Companies
Categories
Company Capabilities
Add New Company
Outsourcing Directory
BMP Medical
Arthur G Russell Company, The
Cirtec Medical
Medbio LLC
Providence Enterprise USA Inc.
MPO Summit
Industry Events
Webinars
Live From Show Event
Industry Associations
Videos
Career Central
eBook
Slideshows
Top Resources
Achieving ISO 27001:2022 Certification in Healthcare: A Practitioner's Guide
Cross-Border Collaboration in Medical Device Development
Data Integrity: Prepare for Change
Managing Contract Complexity in the Medtech Industry
The Secret Weapon Behind Tomorrow's Medical Device Services
Companies
News Releases
Product Releases
Press Releases
Product Spec Sheets
Service Releases
Case Studies
White Papers
Brochures
Videos
Outsourcing Directory
BMP Medical
Arthur G Russell Company, The
Cirtec Medical
Medbio LLC
Providence Enterprise USA Inc.
Magazine
Current/Back Issues
Features
Editorial
Columns
Digital Editions
Subscribe Now
Advertise Now
News
Directory
All Companies
ALL CATEGORIES
Industry Associations
Company Capabilities
Add Your Company
Supply Chain
3D/Additive Manufacturing
Contract Manufacturing
Electronics
Machining & Laser Processing
Materials
Molding
Packaging & Sterilization
R&D & Design
Software & IT
Testing
Tubing & Extrusion
Device Sectors
Cardiovascular
Diagnostics
Digital Health
Neurological
Patient Monitoring
Surgical
Orthopedics
Top 30 Company Report
Expert Insights
Slideshows
Videos
eBook
Resources
Podcasts
Infographics
Whitepapers
Research
White Papers
Case Studies
Product Spec Sheets
Market Data
MPO Summit
Events
Industry Events
Live From Show Events
Webinars
Microsite
Companies
Product Releases
Product Spec Sheets
Services
White Papers / Tech Papers
Press Releases
Videos
Literature / Brochures
Case Studies
About Us
About Us
Contact Us
Advertise with Us
eNewsletter Archive
Privacy Policy
Terms of Use
Podcasts
All
Supply Chain
Device Sectors
Digital Health
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards—Mike on Medtech
Mike Drues and Sean Fenske look at the medtech-centric items on the list and discuss why they are a concern.
Sean Fenske, Editor-in-Chief
03.19.24
Examining Institutional Review Boards—Mike on Medtech
Mike Drues and Sean Fenske take a look at the purpose of IRBs and the role they play in a medical device clinical trial.
Sean Fenske, Editor-in-Chief
03.06.24
Reimbursing Breakthrough Designation Products—Mike on Medtech
Mike Drues and Sean Fenske review the attempts being made to pay for innovative technology as designated by the FDA’s Breakthrough program.
Sean Fenske, Editor-in-Chief
01.02.24
Strengthening the 510k Program—Mike on Medtech
Mike Drues and Sean Fenske discuss three recent guidances put out by the agency in an attempt to bolster the regulatory pathway.
Sean Fenske, Editor-in-Chief
12.19.23
Medical Device Manufacturing Recalls—Mike on Medtech
Mike Drues and Sean Fenske discuss the reasons for the increase in recalls for manufacturing issues and how to avoid them.
Sean Fenske, Editor-in-Chief
10.03.23
AI Predetermined Change Control Plan—Mike on Medtech
Mike Drues and Sean Fenske discuss an FDA guidance that would outline how AI or ML technologies could be allowed to evolve without new submissions.
Sean Fenske, Editor-in-Chief
09.19.23
Can You Use a Recalled Device as a Predicate?—Mike on Medtech
Mike Drues and Sean Fenske discuss why and how a medical device manufacturer might use a device that went through a recall as a predicate for a new product.
Sean Fenske, Editor-in-Chief
06.20.23
Leading Issues from FDA Inspections (or History Repeating Itself)—Mike on Medtech
Mike Drues and Sean Fenske discuss why medical device manufacturers continue to rack up the same types of 483s from FDA inspections.
Sean Fenske, Editor-in-Chief
04.04.23
Diagnostics
To Regulate or Not to Regulate…LDTs, Part 2—Mike on Medtech
Mike Drues and Sean Fenske continue the discussion on the controversy involving LDTs and whether the FDA should regulate them.
Sean Fenske, Editor-in-Chief
02.07.23
Diagnostics
To Regulate or Not to Regulate…Lab Developed Tests, Part 1—Mike on Medtech
Mike Drues and Sean Fenske review the controversy surrounding lab developed tests and discuss whether or not it makes sense for FDA to regulate them.
Sean Fenske, Editor-in-Chief
01.31.23
What Happens When the EUA Period Ends?—Mike on Medtech
Mike Drues and Sean Fenske discuss what happens when the emergency use authorization period ends and what device makers need to do then.
Sean Fenske, Editor-in-Chief
12.13.22
What Does 510k Exempt Actually Mean?—Mike on Medtech
Mike Drues and Sean Fenske review the term and discuss what types of devices are exempt, as well as the meaning of the term itself.
Sean Fenske, Editor-in-Chief
11.29.22
How Can Off-Label Use Be Promoted?—Mike on Medtech
Mike Drues and Sean Fenske look at the promotion of off-label use for a medical device and the ways in which it can be done successfully.
Sean Fenske, Editor-in-Chief
11.15.22
FDA's Intended Use Rule’s Relation to Labeling—Mike on Medtech
Mike Drues and Sean Fenske review the agency’s Intended Use rule that was made final last year and discuss its impact on labeling.
Sean Fenske, Editor-in-Chief
11.01.22
Gaining an Advantage Through Class II Special Controls—Mike on Medtech
Mike Drues and Sean Fenske look at the FDA’s Special Controls that are tied to Class II medical devices and how they can be leveraged by a company.
Sean Fenske, Editor-in-Chief
10.25.22
FDA’s Refusal to Accept Policy for 510(k)s—Mike on Medtech
Mike Drues and Sean Fenske review the latest guidance on Refuse to Accept and why the occurrence happens much too often.
Sean Fenske, Editor-in-Chief
10.18.22
Initiating a Voluntary Medical Device Recall—Mike on Medtech
Mike Drues and Sean Fenske discuss recalls with a specific focus on voluntary recalls, why they occur, and how to be ready for one.
Sean Fenske, Editor-in-Chief
10.11.22
A Letter to File Deep Dive—Mike on Medtech
Mike Drues and Sean Fenske discuss how a letter to file is to be used, when to use it, and how to avoid problems with FDA.
Sean Fenske, Editor-in-Chief
10.04.22
Humacyte’s Bioengineered Tissue Platform Technology
MPO's Sean Fenske speaks with Dr. Juliana Blum of Humacyte about the company’s regenerative medicine product.
Sean Fenske, Editor-in-Chief
03.08.22
Chronic Disease
Koya Medical Restores Mobility for Compression Therapy Patients
MPO's Sean Fenske speaks with Andy Doraiswamy of Koya Medical about providing compression therapy on-the-go.
Sean Fenske, Editor-in-Chief
03.01.22
Breaking News
Reprieve Cardiovascular Emerges From Stealth Mode With $42M Financing
Wearable Neuromodulation System for Urinary Incontinence Makes its Debut
Clinical Data Support Early Detection Ability of IR-MED's Pressure Injury Device
FineHeart Widens FlowMaker's International IP Protection
Encore Medical Device Repair Introduces Robotic Remanufacturing and Sustainability Program at HSPA
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
View More >