Medical Device Regulations

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Medical Device Regulations

Is this the End of MCIT Payments for Breakthrough Devices Is this the End of MCIT Payments for Breakthrough Devices

CMS has given a definitive answer on the future of the payment proposal.

Nov 15, 2021

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1 Min Read

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Medical Device Regulations

Risk Management Means So Much More than EU Medical Device Regulation Compliance Risk Management Means So Much More than EU Medical Device Regulation Compliance

Oct 19, 2021

4 Min Read

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Medical Device Regulations

Get Ready for a Massive Shakeup in NIH Leadership Get Ready for a Massive Shakeup in NIH Leadership

Oct 5, 2021

2 Min Read

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Medical Device Regulations

The Case for Clinical Adjudication in Medical Device Trials The Case for Clinical Adjudication in Medical Device Trials

byKathleen Dowell

Oct 4, 2021

3 Min Read

Medical Device Regulations

Medtech in a Minute: Antitrust Regulators Could Throw the Book at Illumina and Grail Medtech in a Minute: Antitrust Regulators Could Throw the Book at Illumina and Grail

Oct 1, 2021

3 Min Read

medical device liability discussion at The Virtual MedTech Conference 2021

Regulatory & Quality

It's Time to Flip the Script on Medical Device Liability Jury Trials It's Time to Flip the Script on Medical Device Liability Jury Trials

byAmanda Pedersen

Sep 30, 2021

11 Min Read

Medical Device Regulations

11 FDA Plans You Need to Know About

11 FDA Plans You Need to Know About

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Regulatory & Quality

Axonics CEO: We Refuse to Be Intimidated by Medtronic

Axonics CEO: We Refuse to Be Intimidated by Medtronic

byAmanda Pedersen

Medical Device Regulations

A Look at the Australian Medtech Market

A Look at the Australian Medtech Market

byRobert Batchelor

Medtech news

Regulatory & Quality

Medtech in a Minute: Can't We All Just Get Along?

Medtech in a Minute: Can't We All Just Get Along?

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Regulatory & Quality

These People Are Obsessed with the Elizabeth Holmes Trial and So Are We

These People Are Obsessed with the Elizabeth Holmes Trial and So Are We

byAmanda Pedersen

Medical Device Regulations in the United Kingdom and in Europe

Medical Device Regulations

Changing Medical Device Regulations in the United Kingdom and in Europe

Changing Medical Device Regulations in the United Kingdom and in Europe

byAngela Spång

Medtech news

Medical Device Regulations

Medtech in a Minute: Illumina Sticks It to the Man, and More

Medtech in a Minute: Illumina Sticks It to the Man, and More

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Medical Device Regulations

PMCF Surveys: Deciding upon the Correct Approach

PMCF Surveys: Deciding upon the Correct Approach

Medtech news

Regulatory & Quality

Medtech in a Minute: Abbott Settles Allegations Against Alere, and More

Medtech in a Minute: Abbott Settles Allegations Against Alere, and More

Medical Device Regulations

Validating Software as a Medical Device (SaMD)

Validating Software as a Medical Device (SaMD)

Medical Device Regulations

Secure by Design: Developing Cybersecure Medical Devices

Secure by Design: Developing Cybersecure Medical Devices

byDr. Abtin Rad

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Risk Management—What’s Failure Analysis Got to Do With It?

Risk Management—What’s Failure Analysis Got to Do With It?

Medical Device Regulations

Warning Letters and What They Mean for Healthcare Lending

Warning Letters and What They Mean for Healthcare Lending

byPeter Lindsay, Stacy Hopkins

Medical Device Packaging Insider Tips: Must-See Videos

Medical Device Packaging Insider Tips: Must-See Videos

byLisa McTigue Pierce

Regulatory & Quality

Intellectual Property Rights During—and After—a Pandemic

Intellectual Property Rights During—and After—a Pandemic

Abbott’s CE Mark for Navitor is a New Chapter for TAVR

Abbott’s CE Mark for Navitor is a New Chapter for TAVR

Medical Device Regulations

How Will UK’s MMD and EU’s MDR Affect the Medtech Industry?

How Will UK’s MMD and EU’s MDR Affect the Medtech Industry?

Artificial Intelligence

AI-Enabled Prostate Cancer Therapy Wins Breakthrough Designation

AI-Enabled Prostate Cancer Therapy Wins Breakthrough Designation

MCIT coverage for Medicare beneficiaries

Medical Device Regulations

MCIT Ruling Increases Access to Digital Therapeutic Innovation

MCIT Ruling Increases Access to Digital Therapeutic Innovation

Fractyl’s Latest Milestone: Breakthrough Device Designation

Fractyl’s Latest Milestone: Breakthrough Device Designation

Medical Device Regulations

Chemical Compliance Requirements for EU MDR and IVDR

Chemical Compliance Requirements for EU MDR and IVDR

byNigel Syrotuck

Even More Woes for Illumina’s Proposed Acquisition of Grail

Even More Woes for Illumina’s Proposed Acquisition of Grail

Understanding Regulatory Expectations for Combination Products

Understanding Regulatory Expectations for Combination Products

One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Medical Device Regulations

One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain

Medtech news

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

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

byAmanda Pedersen

FDA

Regulatory & Quality

Back to Basics: FDA to Host Workshop for Device Industry

Back to Basics: FDA to Host Workshop for Device Industry

Medical Device Regulations

J&J’s New Lenses Break the Limit for Traditional Contact Use

J&J’s New Lenses Break the Limit for Traditional Contact Use

Medical Device Regulations

A Major Turning Point for COVID-19-Related Diagnostics

A Major Turning Point for COVID-19-Related Diagnostics

artificial intelligence

Artificial Intelligence

Developing Artificial Intelligence for Medical Devices

Developing Artificial Intelligence for Medical Devices

byDr. Abtin Rad

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