Regulatory & Quality

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Tracheostomy Tube
Regulatory & Quality
Smiths Medical Identifies Issue with Bivona Tracheostomy TubesSmiths Medical Identifies Issue with Bivona Tracheostomy Tubes

The company initiated an urgent field safety notice in May detailing that the securement flange of specific lots of the products could tear due to a manufacturing defect.

byKatie Hobbins
Sep 6, 2024
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1 Min Read
FreeStyle Libre 3
Regulatory & Quality
Abbott FreeStyle Libre 3 CGM Recall Designated Class IAbbott FreeStyle Libre 3 CGM Recall Designated Class I
byKatie Hobbins
Sep 6, 2024
1 Min Read
McGrath MAC Video Laryngoscope
Regulatory & Quality
Medtronic Issues Explosive McGrath MAC Video Laryngoscope RecallMedtronic Issues Explosive McGrath MAC Video Laryngoscope Recall
byKatie Hobbins
Sep 5, 2024
3 Min Read
Blood Clot
Regulatory & Quality
Six Deaths Connected to Inari ClotTriever XL RecallSix Deaths Connected to Inari ClotTriever XL Recall
byKatie Hobbins
Sep 4, 2024
2 Min Read
FDA Recall
Regulatory & Quality
Baxter’s Volara System Recall Gets Class I TreatmentBaxter’s Volara System Recall Gets Class I Treatment
byKatie Hobbins
Sep 4, 2024
2 Min Read
PeGraphic featuring MD+DI senior editor Amanda Pedersen's headshot and a pull quote from her latest Pedersen's POV editorial.
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
Aug 23, 2024
4 Min Read
quality control inspector (man in a business suit) writing on a clipboard
QA/QC
That Time FDA was ‘Unusually Thorough’ on a Form 483
That Time FDA was ‘Unusually Thorough’ on a Form 483
Aug 19, 2024
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2 Min Read
byAmanda Pedersen
Artificial Intelligence
Artificial Intelligence
AI Regulations: A Priority for Medical Device Manufacturers
AI Regulations: A Priority for Medical Device Manufacturers
Aug 16, 2024
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5 Min Read
byClive Hudson
FDA
Regulatory & Quality
Globus Medical Faces FDA Ire in New Warning Letter
Globus Medical Faces FDA Ire in New Warning Letter
Aug 13, 2024
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4 Min Read
byKatie Hobbins
Artificial Intelligence
How to Meet Compliance Requirements for the AI Act
Meeting Compliance Requirements for the AI Act
Aug 13, 2024
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9 Min Read
byOmar Ford
Vivo 45 LS Ventilator
Regulatory & Quality
Breas Medical Initiates Vivo 45 LS Ventilator Correction
Breas Medical Initiates Vivo 45 LS Ventilator Correction
Aug 12, 2024
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2 Min Read
byKatie Hobbins
EU MDR
Medical Device Regulations
Is EU MDR Worth the Hassle and Expense?
Is EU MDR Worth the Hassle and Expense?
Aug 8, 2024
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6 Min Read
byLisette Hilton
Medtronic NIM Vital Nerve Monitoring System
Regulatory & Quality
Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I
Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I
Aug 7, 2024
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1 Min Read
byKatie Hobbins
Infusion
Regulatory & Quality
Smiths Medical Corrects CADD-Solis Software
Smiths Medical Corrects CADD-Solis Software
Aug 7, 2024
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1 Min Read
byKatie Hobbins
Canyon Labs' new accelerated aging chamber
Packaging
Medical Device Testing Lab Acquires Accelerated Aging Chamber
Medical Device Testing Lab Acquires Accelerated Aging Chamber
Aug 2, 2024
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2 Min Read
European Commission
Medical Device Regulations
European Medicines Agency Unveil Orphan Medical Device Pilot Program
European Medicines Agency Unveil Orphan Medical Device Pilot Program
Aug 2, 2024
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2 Min Read
byKatie Hobbins
Spine
Surgical
Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance
Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance
Jul 31, 2024
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1 Min Read
byKatie Hobbins
Sponsored Content
FOCUS ON FUNDAMENTALS - Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations
Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations
Aug 20, 2024
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1 Hr View
Checklist
Regulatory & Quality
What Devices Made FDA's Naughty List in July?
What Devices Made FDA's Naughty List in July?
Jul 26, 2024
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7 Slides
byKatie Hobbins
Medical Device Regulations
Medtech in a Minute: Big Collabs, and a High-Profile Retirement
Medtech in a Minute: Big Collabs, and a High-Profile Retirement
Jul 26, 2024
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1 Min Read
Abbott Laboratories
Regulatory & Quality
Abbott Recall Small Number of FreeStyle Libre 3 Sensors
Abbott Recall Small Number of FreeStyle Libre 3 Sensors
Jul 25, 2024
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2 Min Read
byKatie Hobbins
Headshot of CDRH Director Jeff Shuren
Medical Device Regulations
From Toxic to Transparent: How Shuren's Leadership Transformed CDRH
From Toxic to Transparent: How Shuren's Leadership Transformed CDRH
Jul 25, 2024
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4 Min Read
byAmanda Pedersen
Sponsored Content
Biocompatibility as a Critical Design Input
Biocompatibility as a Critical Design Input
Jul 23, 2024
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48 Min View
Quality Alert
QA/QC
FDA Update Plastic Syringe Safety Communication
FDA Update Plastic Syringe Safety Communication
Jul 22, 2024
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2 Min Read
byKatie Hobbins
Graphic illustrating hot topics in the medtech industry in July 2024 (Masimo proxy fight, JD Vance's medical investments, ventilator recalls, etc)
Business
5 Things Medtech Is Talking About in July
5 Things Medtech Is Talking About in July
Jul 18, 2024
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1 Min Read
byAmanda Pedersen
FDA HQ
Regulatory & Quality
What the Heck is Going on at Baxter?
What the Heck is Going on at Baxter?
Jul 17, 2024
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2 Min Read
byKatie Hobbins
Recall
Regulatory & Quality
Bausch + Lomb/Synergetics Recall I-Pack Injection Kits
Bausch + Lomb/Synergetics Recall I-Pack Injection Kits
Jul 16, 2024
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1 Min Read
byKatie Hobbins
Product recall
Regulatory & Quality
Baxter Recall Life2000 Ventilators with Attached Battery Charger Dongle
Baxter Recall Life2000 Ventilators with Attached Battery Charger Dongle
Jul 15, 2024
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2 Min Read
byKatie Hobbins
Photo Hamilton Medical's Hamilton-G5 medical ventilators
Software
Could Better Software Testing Have Prevented a Death?
Could Better Software Testing Have Saved a Life?
Jul 15, 2024
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2 Min Read
byAmanda Pedersen
spiral-bound book of Code of Federal Regulations (CFR)
Manufacturing
Top 5 CRF 21 Non-Compliance Citations – and How to Avoid Them
Top 5 CRF 21 Non-Compliance Citations – and How to Avoid Them
Jul 11, 2024
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4 Slides
byAmanda Pedersen
DreamStation CPAP sleep apnea machine manufactured by Philips, part of the company's massive June 2021 recall of respiratory devices.
Regulatory & Quality
Philips Respironics’ Alleged Mishandling of Safety Concerns: New Insights Emerge
Philips Respironics’ Alleged Mishandling of Safety Concerns: New Insights Emerge
Jul 11, 2024
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2 Min Read
byAmanda Pedersen
Blood culture media bottles
Regulatory & Quality
BD Bactec Blood Culture Media Bottles in Shortage
BD Bactec Blood Culture Media Bottles in Shortage
Jul 10, 2024
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2 Min Read
byKatie Hobbins
Instructions for use
Regulatory & Quality
Philips Updates Sense XL Torso Coil Use Instructions
Philips Updates Sense XL Torso Coil Use Instructions
Jul 9, 2024
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1 Min Read
byKatie Hobbins
FDA Recall
Regulatory & Quality
Inspire IV Implantable Pulse Generator FDA Recalled
Inspire IV Implantable Pulse Generator FDA Recalled
Jul 9, 2024
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2 Min Read
byKatie Hobbins
Clinical trial
Regulatory & Quality
Women Still Underrepresented in Medical Device Clinical Trials
Women Still Underrepresented in Medical Device Clinical Trials
Jul 8, 2024
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1 Min Read
byKatie Hobbins

Editors' Choice

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Manufacturing
Johnson & Johnson, Flex to Keynote at MEDevice Silicon Valley on the Future of Technology & Security in Patient CareJohnson & Johnson, Flex to Keynote at MEDevice Silicon Valley
byStaff
Sep 6, 2024
2 Min Read
Tracheostomy Tube
Regulatory & Quality
Smiths Medical Identifies Issue with Bivona Tracheostomy TubesSmiths Medical Identifies Issue with Bivona Tracheostomy Tubes
byKatie Hobbins
Sep 6, 2024
1 Min Read
FreeStyle Libre 3
Regulatory & Quality
Abbott FreeStyle Libre 3 CGM Recall Designated Class IAbbott FreeStyle Libre 3 CGM Recall Designated Class I
byKatie Hobbins
Sep 6, 2024
1 Min Read
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