Medical Device Regulations

Medtech news
IVD
Medtech in a Minute: FTC Crosses Swords with Illumina, Hologic's Shopping Spree Continues, and MoreMedtech in a Minute: FTC Crosses Swords with Illumina, Hologic's Shopping Spree Continues, and More

Pressed for time? Here's the medtech news you need most, in one minute or less.

byAmanda Pedersen
Apr 9, 2021
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2 Min Read
FDA
Regulatory & Quality
Back to Basics: FDA to Host Workshop for Device IndustryBack to Basics: FDA to Host Workshop for Device Industry
byMDDI Staff
Apr 7, 2021
1 Min Read
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Medical Device Regulations
J&J’s New Lenses Break the Limit for Traditional Contact UseJ&J’s New Lenses Break the Limit for Traditional Contact Use
byOmar Ford
Mar 24, 2021
2 Min Read
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Medical Device Regulations
A Major Turning Point for COVID-19-Related DiagnosticsA Major Turning Point for COVID-19-Related Diagnostics
byMDDI Staff
Mar 18, 2021
2 Min Read
artificial intelligence
Artificial Intelligence
Developing Artificial Intelligence for Medical DevicesDeveloping Artificial Intelligence for Medical Devices
byDr. Abtin Rad
Mar 17, 2021
7 Min Read
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Regulatory & Quality
FDA Lays Out Flaws Made in Initial Antibody Testing GuidanceFDA Lays Out Flaws Made in Initial Antibody Testing Guidance
byOmar Ford
Feb 17, 2021
2 Min Read
Why Risk-Based Thinking Is Essential in Medical Device Development logo in a gray background | Why Risk-Based Thinking Is Essential in Medical Device Development
Medical Device Regulations
Why Risk-Based Thinking Is Essential in Medical Device Development
Why Risk-Based Thinking Is Essential in Medical Device Development
Feb 9, 2021
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5 Min Read
byKim Jackson
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Medical Device Regulations
When Software Becomes a Medical Device
When Software Becomes a Medical Device
Feb 8, 2021
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6 Min Read
byDr. Abtin Rad
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Cardiovascular
Medtronic Wins Nod for Afib Treatment Device
Medtronic Wins Nod for Afib Treatment Device
Jan 29, 2021
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2 Min Read
byOmar Ford
FDA Adds New Regulatory Science Tools for Assessing Medical Devices logo in a gray background | FDA Adds New Regulatory Science Tools for Assessing Medical Devices
Regulatory & Quality
FDA Adds New Regulatory Science Tools for Assessing Medical Devices
FDA Adds New Regulatory Science Tools for Assessing Medical Devices
Jan 24, 2021
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1 Min Read
byAmanda Pedersen
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Medical Device Regulations
Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS
Boston Sci Wins Nod for 4th Gen. Vercise Genus DBS
Jan 22, 2021
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1 Min Read
byMDDI Staff
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Business
Qiagen Resubmits EUA Application for QIAreach Antigen Test
Qiagen Resubmits EUA Application for QIAreach Antigen Test
Jan 21, 2021
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1 Min Read
byMDDI Staff
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Design & Engineering
Can Design Controls Accelerate Medical Innovation?
Can Design Controls Accelerate Medical Innovation?
Nov 16, 2020
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7 Min Read
byAndrew J. DiMeo, Sr., Ph.D. 
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Medical Device Regulations
Traceability Requirements in EU MDR
Traceability Requirements in EU MDR
Nov 12, 2020
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4 Min Read
byJon Speer
Medtech Unfiltered - Affordable Care Act
Medical Device Regulations
Medtech Unfiltered: Should the Affordable Care Act be Struck Down?
Medtech Unfiltered: Should the Affordable Care Act be Struck Down?
Nov 10, 2020
byMDDI Staff
telehealth
Digital Health
Telehealth Considerations for Medical Device Manufacturers During and After COVID-19
Telehealth Considerations for Medical Device Manufacturers During and After COVID-19
Oct 20, 2020
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11 Min Read
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Medical Device Regulations
Building a Better Supply Chain Through Unique Device Identification
Building a Better Supply Chain Through Unique Device Identification
Oct 20, 2020
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5 Min Read
byBeth Wells
COVID test
Regulatory & Quality
Before You Throw Out That FDA Guidance on Lab-Developed COVID Tests ...
Before You Throw Out That FDA Guidance on Lab-Developed COVID Tests ...
Oct 15, 2020
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3 Min Read
byAmanda Pedersen
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Medical Device Regulations
8 Important Medtech Updates from FDA
8 Important Medtech Updates from FDA
Oct 15, 2020
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9 Slides
byDaphne Allen
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Medical Device Regulations
FDA Veteran Outlines Bold Plans to Increase Diversity in Medtech Industry
FDA Veteran Outlines Bold Plans to Increase Diversity in Medtech Industry
Oct 5, 2020
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7 Min Read
byMDDI Staff
MAETRICS
Medical Device Regulations
Economic Operators: The EU MDR Compliance Journey for the Supply Chain
Economic Operators: The EU MDR Compliance Journey for the Supply Chain
Oct 1, 2020
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5 Min Read
byBeth Crandall
Affordable Care Act
Medical Device Regulations
What If the Affordable Care Act Is Overturned?
What If the Affordable Care Act Is Overturned?
Sep 21, 2020
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2 Min Read
byAmanda Pedersen
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IVD
Medtech Unfiltered: Who Is Elizabeth Holmes?
Medtech Unfiltered: Who Is Elizabeth Holmes?
Sep 17, 2020
byMDDI Staff
COVID-19 pandemic and regulations
Medical Device Regulations
Has the Pandemic Impacted Medtech Regulation?
Has the Pandemic Impacted Medtech Regulation?
Sep 12, 2020
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12 Min Read
byDaphne Allen
Medtech
Medical Device Regulations
Medtech in a Minute: NeuroMetrix Refunds, Big IPO News, and More
Medtech in a Minute: NeuroMetrix Refunds, Big IPO News, and More
Sep 11, 2020
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3 Min Read
byAmanda Pedersen
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Neurological
Boston Sci Launches 4th Generation DBS System in Europe
Boston Sci Launches 4th Generation DBS System in Europe
Sep 10, 2020
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1 Min Read
byOmar Ford
Medtech AI and Software Regulation in China
Medical Device Regulations
Medtech AI & Software Regulation in China: 5 Things to Know
Medtech AI & Software Regulation in China: 5 Things to Know
Sep 8, 2020
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9 Min Read
byHamish E.S. King
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Medical Device Regulations
EU MDR Delay: What Does It Mean for Biocompatibility and Chemical Characterization?
EU MDR Delay: What Does It Mean for Biocompatibility and Chemical Characterization?
Sep 1, 2020
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4 Min Read
byDaphne Allen
healthcare statements from RNC 2020
Business
2020 US Election: What Republicans Said About Healthcare
2020 US Election: What Republicans Said About Healthcare
Aug 31, 2020
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9 Slides
byDaphne Allen, Amanda Pedersen
Medtech in a Minute
Drug Delivery
Medtech in a Minute: Convalescent Plasma Controversy, and More
Medtech in a Minute: Convalescent Plasma Controversy, and More
Aug 31, 2020
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2 Min Read
byAmanda Pedersen
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IVD
Foundation Medicine Secures FDA Nod for Pan Tumor Test
Foundation Medicine Secures FDA Nod for Pan Tumor Test
Aug 28, 2020
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1 Min Read
byOmar Ford
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IVD
Medtech Unfiltered: Pedersen Talks Trump and FDA
Medtech Unfiltered: Pedersen Talks Trump and FDA
Aug 26, 2020
byMDDI Staff
healthcare statements from DNC 2020
Medical Device Regulations
2020 US Election: What Democrats Said About Healthcare
2020 US Election: What Democrats Said About Healthcare
Aug 25, 2020
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11 Slides
byDaphne Allen, Amanda Pedersen
Medtech Unfiltered
IVD
Medtech Unfiltered: Let's Talk Trump and FDA
Medtech Unfiltered: Let's Talk Trump and FDA
Aug 21, 2020
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1 Min Read
byAmanda Pedersen
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IVD
Trump Administration Nixes FDA’s Ability to Regulate Laboratory-Developed Tests
Trump Administration Nixes FDA’s Ability to Regulate Laboratory-Developed Tests
Aug 21, 2020
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4 Min Read
byOmar Ford

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