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Regulatory & Quality

Sentec/Percussionaire Phasitron 5 In-Line Valve Gets IFU Updates Sentec/Percussionaire Phasitron 5 In-Line Valve Gets IFU Updates

In a Class I correction, the company said it is updating the instructions for use after it uncovered the potential of accidental misuse of the expiratory port plug.

byKatie Hobbins

Oct 3, 2024

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2 Min Read

Regulatory & Quality

Philips Respironics Corrects Trilogy Ventilators Software, Use Instructions Philips Respironics Corrects Trilogy Ventilators Software, Use Instructions

byKatie Hobbins

Oct 2, 2024

2 Min Read

Regulatory & Quality

Gilead Sciences Recall Veklury for Injection 100 mg/Vial Gilead Sciences Recall Veklury for Injection 100 mg/Vial

byKatie Hobbins

Oct 2, 2024

1 Min Read

Regulatory & Quality

Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction

byKatie Hobbins

Oct 1, 2024

2 Min Read

People reacting to a scary movie in a movie theater.

This Medical Device Has a Scary History This Medical Device Has a Scary History

byAmanda Pedersen

Oct 1, 2024

2 Min Read

hand holding a brown envelope open to reveal a piece of paper with the text: WARNING at the top.

Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’

byAmanda Pedersen

Sep 30, 2024

2 Min Read

Sponsored Content

How to Decode & Master Section 524B Cybersecurity with Open-Source

How to Decode & Master Section 524B Cybersecurity with Open-Source

Sponsored Content

Inspecting Medical Devices at Scale with Automated Industrial CT Scanning

Inspecting Medical Devices at Scale with Automated Industrial CT Scanning

FDA Headquarters

Regulatory & Quality

Fractures Form for Zimmer Biomet’s CPT Hip System

Fractures Form for Zimmer Biomet’s CPT Hip System

byKatie Hobbins

B. Braun Medical

Regulatory & Quality

B. Braun Medical Adds Another Infusomat Pump to 2023 Recall

B. Braun Medical Adds Another Infusomat Pump to 2023 Recall

byKatie Hobbins

Ivenix infusion system

Regulatory & Quality

Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024

Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024

byKatie Hobbins

Sponsored Content

How different are the EU & FDA medical device regulations?

How different are the EU & FDA medical device regulations?

Tampon

Toxic Tampons: Fact vs Fiction

Toxic Tampons: Fact vs Fiction

byKatie Hobbins

Sponsored Content

A Prescription For Security

A Prescription For Security

Pull-quote graphic accompanying the op-ed piece Pedersen's POV on the end of the "sexy medtech era" under the Affordable Care Act.

Medical Device Regulations

The End of Sexy Medtech: How Value-Based Care Changed the Game

The End of Sexy Medtech: How Value-Based Care Changed the Game

byAmanda Pedersen

Artificial Intelligence

AI-Enabled Medical Devices: Regulatory Trends in the United States & Beyond

Regulatory Trends for AI in the United States & Beyond

byHeather R. Johnson

Former President Donald Trump and Vice President Kamala Harris in a presidential debate at the National Constitution Center in Philadelphia, PA.

Medical Device Regulations

Healthcare Showdown: Trump and Harris Spar Over Legacy of 'Obamacare'

Healthcare Showdown: Trump and Harris Spar Over Legacy of 'Obamacare'

byAmanda Pedersen

Nonclinical Testing

Regulatory & Quality

Two Nonclinical Testing Laboratories Hit with Warning Letters

Two Nonclinical Testing Laboratories Hit with Warning Letters

byKatie Hobbins

False Claims Act

Medical Device Regulations

THD America Pay $700,000 to Resolve False Claims Act Violation Allegations

THD America Pay $700,000 to Resolve False Claims Act Violation Allegations

byKatie Hobbins

Compliance

Regulatory & Quality

How to Survive FDA’s Predetermined Change Control Plan

How to Survive FDA’s Predetermined Change Control Plan

byErez Kaminski

FDA recall

Regulatory & Quality

FDA Recall Roundup: August 2024

FDA Recall Roundup: August 2024

byKatie Hobbins

Sponsored Content

Navigating FDA Section 524B

Navigating FDA Section 524B

Sponsored Content

Delivering Advancements in Medical Devices

Delivering Advancements in Medical Devices

Tracheostomy Tube

Regulatory & Quality

Smiths Medical Identifies Issue with Bivona Tracheostomy Tubes

Smiths Medical Identifies Issue with Bivona Tracheostomy Tubes

byKatie Hobbins

FreeStyle Libre 3

Regulatory & Quality

Abbott FreeStyle Libre 3 CGM Recall Designated Class I

Abbott FreeStyle Libre 3 CGM Recall Designated Class I

byKatie Hobbins

McGrath MAC Video Laryngoscope

Regulatory & Quality

Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall

Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall

byKatie Hobbins

Blood Clot

Regulatory & Quality

Six Deaths Connected to Inari ClotTriever XL Recall

Six Deaths Connected to Inari ClotTriever XL Recall

byKatie Hobbins

FDA Recall

Regulatory & Quality

Baxter’s Volara System Recall Gets Class I Treatment

Baxter’s Volara System Recall Gets Class I Treatment

byKatie Hobbins

Catheter sterile medical device

FDA Experts Delve into Sterilization Topics

FDA Experts Delve into Sterilization Topics

byKassandra Kania

Medical Device Regulations

'Not Going Back' to the Shultz Era of Medical Device Regulation

'Not Going Back' to the Shultz Era of Medical Device Regulation

byAmanda Pedersen

quality control inspector (man in a business suit) writing on a clipboard

That Time FDA was ‘Unusually Thorough’ on a Form 483

That Time FDA was ‘Unusually Thorough’ on a Form 483

byAmanda Pedersen

Artificial Intelligence

Artificial Intelligence

AI Regulations: A Priority for Medical Device Manufacturers

AI Regulations: A Priority for Medical Device Manufacturers

FDA

Regulatory & Quality

Globus Medical Faces FDA Ire in New Warning Letter

Globus Medical Faces FDA Ire in New Warning Letter

byKatie Hobbins

Artificial Intelligence

How to Meet Compliance Requirements for the AI Act

Meeting Compliance Requirements for the AI Act

Vivo 45 LS Ventilator

Regulatory & Quality

Breas Medical Initiates Vivo 45 LS Ventilator Correction

Breas Medical Initiates Vivo 45 LS Ventilator Correction

byKatie Hobbins

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