Regulatory & Quality

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EU & Member States Contribute Over $800M to African Vaccines Manufacturing Accelerator EU & Member States Contribute Over $800M to African Vaccines Manufacturing Accelerator

The accelerator will work to enhance demand predictability for African-made vaccines and help support the sustainable growth of the continents manufacturing base.

byKatie Hobbins

Jun 24, 2024

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2 Min Read

FDA Headquarters

Regulatory & Quality

Medline Reaps FDA Ire in Class I Endotracheal Tube Recall Medline Reaps FDA Ire in Class I Endotracheal Tube Recall

byKatie Hobbins

Jun 17, 2024

3 Min Read

Getinge FDA recall

Regulatory & Quality

Getinge Sevoflurane Vaporizer Recall Gets Class I Rating Getinge Sevoflurane Vaporizer Recall Gets Class I Rating

byKatie Hobbins

Jun 14, 2024

2 Min Read

Regulatory & Quality

Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I

byKatie Hobbins

Jun 14, 2024

3 Min Read

Sponsored Content

5 Top 21 CFR Non-Compliance Violations & How to Avoid Them 5 Top 21 CFR Non-Compliance Violations & How to Avoid Them

Jul 9, 2024

1 Hr View

Graphic featuring MD+DI Senior Editor Amanda Pedersen for her weekly medtech opinion column, Pedersen's POV.

The Cost of Greed in Medtech The Cost of Medtech Greed

byAmanda Pedersen

Jun 10, 2024

2 Min Read

EU MDR

Regulatory & Quality

EU MDR Poses Challenges for Manufacturers

EU MDR Poses Challenges for Manufacturers

byBob Kronemyer

LDT overview

ACLA Sues FDA to Block New LDT Oversight

ACLA Sues FDA to Block New LDT Oversight

byKatie Hobbins

Tested coatings keep in-vivo parts and other biotech safe

Sponsored Content

The Importance of USP Class VI Testing

The Importance of USP Class VI Testing

Artificial Intelligence

What You Need to Know About the Artificial Intelligence Act

What You Need to Know About the Artificial Intelligence Act

Product recall

Regulatory & Quality

OptumHealth Nimbus II Pump System Identified as Class I Recall

OptumHealth Nimbus II Pump System Identified as Class I Recall

byKatie Hobbins

MathWorks Medical Devices Industry Manager Dr. Visa Suomi

Could Simulation Advance Your Testing Programs?

Could Simulation Advance Your Testing Programs?

FDA recall

Regulatory & Quality

Medtech Recall Round-Up: May 2024

Medtech Recall Round-Up: May 2024

byKatie Hobbins

recall

Regulatory & Quality

Hologic BioZorb Marker Recall Identified as Class I

Hologic BioZorb Marker Recall Identified as Class I

byKatie Hobbins

Medical Device Regulations

Kicking Open the Door for Electronic FDA Submissions

Kicking Open the Door for Electronic FDA Submissions

byAmanda Pedersen

Peter Wirthschaft, PhD, senior manager, medical device/IVD consultant for global public health and safety organization NSF

Regulatory & Quality

Seeing Double: What to Watch When Bringing Combination Products to the EU Market

Seeing Double: What to Watch When Bringing Combination Products to the EU Market

byHeather R. Johnson

International recognition

Medical Device Regulations

UK Government Propose International Medical Device Recognition Framework

UK Government Propose International Medical Device Recognition Framework

byKatie Hobbins

Shape Memory Medical staff

New Technologies

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

Abbott's HeartMate 3 system is designed to take over the pumping function of the left ventricle, the main pumping chamber of the heart.

Abbott’s HeartMate Problems Trigger Déjà Vu

Abbott’s HeartMate Problems Trigger Déjà Vu

byAmanda Pedersen

Graphic to accompany Pedersen's POV, a weekly opinion column exclusive to MD+DI.

This Dental Device Manufacturer Sets My Teeth on Edge

This Dental Device Manufacturer Sets My Teeth on Edge

byAmanda Pedersen

TGA approval

Regulatory & Quality

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

byKatie Hobbins

Plastic Syringe

Medical Device Regulations

FDA Adds Two New Chinese Manufacturers to Do Not Use Plastic Syringe List

FDA Adds Two New Chinese Manufacturers to Do Not Use Plastic Syringe List

byKatie Hobbins

Masimo recall

Regulatory & Quality

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

byKatie Hobbins

Image of U.S. Capitol building in Washington, DC.

Medical Device Regulations

This Medical Device Company Had to Fight for Its Rights

This Medical Device Company Had to Fight for Its Rights

FDA recall

Regulatory & Quality

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

byKatie Hobbins

Trilogy Evo Ventilators

Regulatory & Quality

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

byKatie Hobbins

FDA recall

Regulatory & Quality

Route 92 Medical Recalls Catheters After Distal Tip Separation

Route 92 Medical Recalls Catheters After Distal Tip Separation

byKatie Hobbins

5 Things You Need to Know About FDA’s Final Rule on LDTs

5 Things You Need to Know About FDA’s Final Rule on LDTs

Diabetes

Regulatory & Quality

Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

byKatie Hobbins

FDA

Regulatory & Quality

Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge Cardiovascular Devices Again Under FDA Microscope

byKatie Hobbins

FDA

Regulatory & Quality

Outset Medical Nabs FDA Clearance for TabloCart

Outset Medical Nabs FDA Clearance for TabloCart

byKatie Hobbins

5 Tips for Choosing a Reliable Testing Partner for Regulatory Success

"Selecting a Reliable Third-party Testing Partner: 5 Tips for Ensuring Successful Regulatory Submissions

byNick Christiano

A Slacker's Guide to Kicking Mandatory Training Deadlines in the Face

A Slacker's Guide to Kicking Mandatory Training Deadlines in the Face

byAmanda Pedersen

Beating Heart

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

byKatie Hobbins

Vitek AST Kit

Regulatory & Quality

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

byKatie Hobbins

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