Medical Device Regulations

China and the US
Medical Device Regulations
How Is Medtech Impacted by a Strained US-China Relationship? A CEO Speaks OutHow Is Medtech Impacted by a Strained US-China Relationship? A CEO Speaks Out

While some believe cutting ties with China would serve as an impetus for more goods to be made in America, some medtech leaders think it could be disastrous — especially during a pandemic.

byAmanda Pedersen
Aug 19, 2020
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8 Min Read
Medtech Unfiltered
Medical Device Regulations
Medtech Unfiltered: Let's Talk Tariffs and Trade WarMedtech Unfiltered: Let's Talk Tariffs and Trade War
byAmanda Pedersen
Aug 17, 2020
1 Min Read
IMG_Aug72020at31726PM.jpg
IVD
Siemens Healthineers Changes Antibody Testing Conversation with New EUASiemens Healthineers Changes Antibody Testing Conversation with New EUA
byOmar Ford
Aug 9, 2020
2 Min Read
IMG_Jul282020at34111PM[1].jpg
New Technologies
Guided Therapeutics Makes Progress with PMA for LuVivaGuided Therapeutics Makes Progress with PMA for LuViva
byOmar Ford
Jul 28, 2020
1 Min Read
IMG_Jul282020at110323AM[1].jpg
Medical Device Regulations
LabCorp Broadens Testing for COVID-19 with New IndicationsLabCorp Broadens Testing for COVID-19 with New Indications
byOmar Ford
Jul 28, 2020
2 Min Read
ReWalk Exoskeleton
New Technologies
ReWalk’s New CMS Code Could Change the Exoskeleton Market ForeverReWalk’s New CMS Code Could Change the Exoskeleton Market Forever
Jul 23, 2020
2 Min Read
EU MDR post-market clinical followup
Medical Device Regulations
EU MDR: Consider Post-Market Clinical Follow-up through End-User Surveys
EU MDR: Consider Post-Market Clinical Follow-up through End-User Surveys
Jul 7, 2020
|
4 Min Read
byMarcus Torr
IMG_Jul22020at125812PM.jpg
Orthopedic
FDA Clears Spinal Elements’s Anterior Cervical Fixation System
FDA Clears Spinal Elements’s Anterior Cervical Fixation System
Jul 2, 2020
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1 Min Read
byMDDI Staff
EU MDR
Medical Device Regulations
EU Medical Device Regulation: What Should You Do During the Delay?
EU Medical Device Regulation: What Should You Do During the Delay?
Jul 1, 2020
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3 Min Read
byDaphne Allen
FDA
IVD
Foundation’s Latest FDA Nod Advances Biomarker-Driven Cancer Treatments
Foundation’s Latest FDA Nod Advances Biomarker-Driven Cancer Treatments
Jun 19, 2020
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3 Min Read
byOmar Ford
IMG_Jun182020at23844PM.jpg
IVD
Chembio’s Antibody Test EUA Revoked by FDA
Chembio’s Antibody Test EUA Revoked by FDA
Jun 18, 2020
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2 Min Read
byOmar Ford
breast implants
Regulatory & Quality
Breast Implant Makers Land in Hot Water with FDA
Breast Implant Makers Land in Hot Water with FDA
May 15, 2020
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5 Min Read
byAmanda Pedersen
How Healthy Is Medical Innovation in the NHS?
Regulatory & Quality
How Healthy Is Medical Innovation in the NHS?
How Healthy Is Medical Innovation in the NHS?
Mar 10, 2020
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4 Min Read
byBarbara Harpham
A Few New Challenges with EU MDR
Regulatory & Quality
A Few New Challenges with EU MDR
A Few New Challenges with EU MDR
Mar 5, 2020
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7 Min Read
byDaphne Allen
Quest Integrity v. Cokebusters Puts Cloud-Based Medical Diagnostic Patents at Risk of On-Sale Bar
Regulatory & Quality
Quest Integrity v. Cokebusters Puts Cloud-Based Medical Diagnostic Patents at Risk of On-Sale Bar
Quest Integrity v. Cokebusters Puts Cloud-Based Medical Diagnostic Patents at Risk of On-Sale Bar
Feb 7, 2020
|
4 Min Read
byMatthew Murphy, David Ludwig
Trump Signs Measure to Repeal Medical Device Tax
Regulatory & Quality
Trump Signs Measure to Repeal Medical Device Tax
Trump Signs Measure to Repeal Medical Device Tax
Dec 23, 2019
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2 Min Read
byOmar Ford
10 Important Updates from FDA
Regulatory & Quality
10 Important Updates from FDA
10 Important Updates from FDA
Oct 7, 2019
|
11 Slides
byDaphne Allen
Patent Considerations for Connected Medical Devices
Digital Health
Patent Considerations for Connected Medical Devices
Patent Considerations for Connected Medical Devices
Sep 4, 2019
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4 Min Read
byPhilip Braginsky
The device is designed to provide a durable, "natural-feeling" erection, and is easier for surgeons to implant.
Implants
New Penis Implant Raises the Bar for Erectile Dysfunction Solutions
New Penis Implant Raises the Bar for Erectile Dysfunction Solutions
Jul 29, 2019
|
2 Min Read
byAmanda Pedersen
What Can You Expect from a Warning Letter?
Regulatory & Quality
What Can You Expect from a Warning Letter?
What Can You Expect from a Warning Letter?
Jun 21, 2019
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5 Min Read
byWilliam A. Hyman
Abbott Offers up Rapid Influenza Diagnostic logo in a gray background | Abbott Offers up Rapid Influenza Diagnostic
IVD
Abbott Offers up Rapid Influenza Diagnostic
Abbott Offers up Rapid Influenza Diagnostic
Feb 27, 2019
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1 Min Read
byStephanie Schupska 1
New Global Compliance Requirements Will Impact Medical Device Industry
Regulatory & Quality
New Global Compliance Requirements Will Impact Medical Device Industry
New Global Compliance Requirements Will Impact Medical Device Industry
Nov 8, 2017
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9 Min Read
byMelonie Warfel
Cook Clears Up Confusion Incited By Zenith Recall logo in a gray background | Cook Clears Up Confusion Incited By Zenith Recall
Medical Device Regulations
Cook Clears Up Confusion Incited By Zenith Recall
Cook Clears Up Confusion Incited By Zenith Recall
Aug 24, 2017
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2 Min Read
byAmanda Pedersen 1
Bos Sci Wins CE Mark for MR-Conditional DBS System logo in a gray background | Bos Sci Wins CE Mark for MR-Conditional DBS System
Medical Device Regulations
Bos Sci Wins CE Mark for MR-Conditional DBS System
Bos Sci Wins CE Mark for MR-Conditional DBS System
Jun 6, 2017
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3 Min Read
byKristopher Sturgis
CE Mark Suspension Adds Insult to GI Dynamics' Injury logo in a gray background | CE Mark Suspension Adds Insult to GI Dynamics' Injury
Medical Device Regulations
CE Mark Suspension Adds Insult to GI Dynamics' Injury
CE Mark Suspension Adds Insult to GI Dynamics' Injury
May 18, 2017
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2 Min Read
byAmanda Pedersen 1
Should You Break Up with Your Notified Body? logo in a gray background | Should You Break Up with Your Notified Body?
Medical Device Regulations
Should You Break Up with Your Notified Body?
Should You Break Up with Your Notified Body?
May 3, 2017
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3 Min Read
How to Survive an Unannounced Audit logo in a gray background | How to Survive an Unannounced Audit
Medical Device Regulations
How to Survive an Unannounced Audit 21
How to Survive an Unannounced Audit
May 3, 2017
|
8 Min Read
St. Jude Pacemaker Wins MRI Compatibility Approval in E.U. logo in a gray background | St. Jude Pacemaker Wins MRI Compatibility Approval in E.U.
Medical Device Regulations
St. Jude Pacemaker Wins MRI Compatibility Approval in E.U.
St. Jude Pacemaker Wins MRI Compatibility Approval in E.U.
Nov 9, 2016
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2 Min Read
byNancy Crotti
Vascular Solutions Hit With Another Class I Recall logo in a gray background | Vascular Solutions Hit With Another Class I Recall
Medical Device Regulations
Vascular Solutions Hit With Another Class I Recall
Vascular Solutions Hit With Another Class I Recall
Oct 7, 2016
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2 Min Read
byMaureen Kingsley
How You Can Stay Compliant With UDI logo in a gray background | How You Can Stay Compliant With UDI
Medical Device Regulations
How You Can Stay Compliant With UDI
How You Can Stay Compliant With UDI
Sep 26, 2016
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6 Min Read
byQmed Staff
Senate Holds Hearing on Lab-Developed Tests logo in a gray background | Senate Holds Hearing on Lab-Developed Tests
Testing
Senate Holds Hearing on Lab-Developed Tests
Senate Holds Hearing on Lab-Developed Tests
Sep 20, 2016
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4 Min Read
byNancy Crotti
Boston Sci's Lotus Edge Wins CE Mark logo in a gray background | Boston Sci's Lotus Edge Wins CE Mark
Medical Device Regulations
Boston Sci's Lotus Edge Wins CE Mark
Boston Sci's Lotus Edge Wins CE Mark
Sep 19, 2016
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2 Min Read
byChris Newmarker
Former J&J Sales Rep Convicted in Stolen Devices Scheme logo in a gray background | Former J&J Sales Rep Convicted in Stolen Devices Scheme
Medical Device Regulations
Former J&J Sales Rep Convicted in Stolen Devices Scheme
Former J&J Sales Rep Convicted in Stolen Devices Scheme
Sep 12, 2016
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3 Min Read
byNancy Crotti
St. Jude Medical May Not Have a Cybersecurity Problem After All logo in a gray background | St. Jude Medical May Not Have a Cybersecurity Problem After All
Medical Device Regulations
St. Jude Medical May Not Have a Cybersecurity Problem After All
St. Jude Medical May Not Have a Cybersecurity Problem After All
Aug 31, 2016
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4 Min Read
byNancy Crotti
Theranos Appealing Tough CMS Sanctions logo in a gray background | Theranos Appealing Tough CMS Sanctions
Medical Device Regulations
Theranos Appealing Tough CMS Sanctions
Theranos Appealing Tough CMS Sanctions
Aug 29, 2016
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3 Min Read
byChris Newmarker

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