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Supply Chain
Device Sectors
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
Neurological
NeuroPace’s Aid in Tracking and Treating Epilepsy
MPO's Sean Fenske speaks with Mike Favet of NeuroPace about a strategic partnership and what it means for those suffering from epilepsy.
Sean Fenske, Editor-in-Chief
02.22.22
Breaking News
DirectMed Imaging Acquires Titanium Medical Imaging
SetPoint Medical Receives FDA Breakthrough Device Designation
Siemens Healthineers to Close Fast Track Diagnostics Biz
Sequel's twiist Automated Insulin Delivery System Wins FDA OK
Biotronik Gets FDA Breakthrough Nod for Freesolve Below-the-Knee Resorbable Magnesium Scaffold
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >