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Regulatory Insights: The Future of MedTech and Pharma Under the New Administration Regulatory Insights: The Future of MedTech and Pharma Under the New Administration

Jan 28, 2025

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Medical Device Regulations

Tackling the Most Burning EU MDR Questions Tackling the Most Burning EU MDR Questions

Jan 23, 2025

1 Min Read

Artificial Intelligence

Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices Navigating FDA’s Draft Guidance for AI-Enabled Medical Devices

byWilliam Betten

Jan 22, 2025

1 Min Read

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Regulatory & Quality

CMS Opens National Coverage Analysis for Renal Denervation to Treat Hypertension CMS Opens NCA for Renal Denervation to Treat Hypertension

Jan 15, 2025

1 Min Read

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Medical Device Regulations

Medtech Implementation of FDA’s Updated QMSR Medtech Implementation of FDA’s Updated QMSR

byBob Kronemyer

Jan 13, 2025

1 Min Read

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Philips Faces a Different Kind of Recall in 2025 Philips Faces a Different Kind of Recall in 2025

Jan 13, 2025

1 Min Read

Regulatory & Quality

CBD Tampons Cramp FDA's Style

CBD Tampons Cramp FDA's Style

byAmanda Pedersen

Doctor analyzes an artificial intelligence processor on a light blue background

Artificial Intelligence

FDA Issues Draft Guidance for AI-Enabled Devices, Seeks Public Feedback

FDA Issues Draft Guidance for AI-Enabled Devices

Man tearing up a piece of paper that reads "FDA Warning Letter"

Regulatory & Quality

The Time FDA Actually Withdrew a Warning Letter

The Time FDA Actually Withdrew a Warning Letter

byAmanda Pedersen

FDA Headquarters

Regulatory & Quality

FDA Wrapped: Prominent Guidance From 2024

FDA Wrapped: Prominent Guidance From 2024

byHeather R. Johnson

Yellow card

Regulatory & Quality

Trokamed Updates Nephroscope Sheath Instructions for Use

Trokamed Updates Nephroscope Sheath Instructions for Use

byKatie Hobbins, Managing Editor

Boston Scientific

Boston Sci Slapped with Safety Communication for Accolade Pacemakers

Boston Sci Slapped with Safety Communication for Accolade Pacemakers

byKatie Hobbins, Managing Editor

Biggest losers

2024’s Biggest Medtech Losers

2024’s Biggest Medtech Losers

byKatie Hobbins, Managing Editor

Regulatory & Quality

MeMed Severity Test Nabs Breakthrough Device Designation

MeMed Severity Test Nabs Breakthrough Device Designation

byKatie Hobbins, Managing Editor

What’s the Point of a Biological Evaluation Report?

What’s the Point of a Biological Evaluation Report?

byJeni Lauer, PhD, Biocompatibility Expert with the Nelson Labs Expert Advisory Services Group

epilepsy

NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment

NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment

byKatie Hobbins, Managing Editor

continuous glucose monitor

Glucotrack Begins Enrollment for Long-term Implantable CGM Study

Glucotrack Begins Enrollment for Long-term Implantable CGM Study

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Baxter Corrects MiniCap Extended Life PD Transfer Sets Due to Toxic Compound Exposure Risk

Baxter Corrects MiniCap Extended Life PD Transfer Sets Due to Toxic Compound Exposure Risk

byKatie Hobbins, Managing Editor

Lungs

Regulatory & Quality

Beyond Air Nabs CE Mark for LungFit PH System

Beyond Air Nabs CE Mark for LungFit PH System

byKatie Hobbins, Managing Editor

Atlan anesthesia workstations

Regulatory & Quality

Draeger Altan Correction Cites Mechanical Ventilation Failure

Draeger Altan Correction Cites Mechanical Ventilation Failure

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

FDA Recall Roundup: October 2024

FDA Recall Roundup: October 2024

byKatie Hobbins, Managing Editor

Close up photo of Dr. Oz attending The Swift Hour during the 2024 Concordia Annual Summit at Sheraton New York Times Square in September 2024

Medical Device Regulations

What Trump's Dr. Oz Nomination Means for Medtech

What Trump's Dr. Oz Nomination Means for Medtech

byAmanda Pedersen

FDA recall

Regulatory & Quality

Smiths Medical Update CADD-Solis Li-ion Rechargeable Battery Pack Use Instructions

Smiths Medical Update CADD-Solis Li-ion Rechargeable Battery Pack Use Instructions

byKatie Hobbins, Managing Editor

Close-up of a prison inmate wearing orange gripping the bars of his cell

Regulatory & Quality

Why Did This Former Army Surgeon Go to Prison?

Why Did This Former Army Surgeon Go to Prison?

byAmanda Pedersen

President-Elect Donald Trump and laboratory-developed tests

Regulatory & Quality

Trump’s Second Term Could Turn LDT Regulation on its Head

Trump’s Second Term Could Turn LDT Regulation on its Head

byKatie Hobbins, Managing Editor

Robert Califf, FDA Commissioner

Medical Device Regulations

Outgoing FDA Commissioner Responds to Possible Changes by Trump Administration

FDA Commissioner Responds to Possible Changes by Trump Administration

Valvosoft from company animation

Novel Treatment for Severe Aortic Stenosis on Track for FDA Nod

Novel Treatment for Severe Aortic Stenosis on Track for FDA Nod

byLisette Hilton, Reporter and President

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Regulatory & Quality

RFK Jr. Wants to Get Rid of 'Entire Departments’ at FDA – Here’s Why That’s Nuts

RFK Jr. Wants to Get Rid of 'Entire Departments’ at FDA – Here’s Why That’s Nuts

byAmanda Pedersen

President-elect Donald Trump

Regulatory & Quality

AdvaMed Reacts to Second Trump Term

AdvaMed Reacts to Second Trump Term

byKatie Hobbins, Managing Editor

Hyperfine Swoop

Regulatory & Quality

Hyperfine Nabs CE Mark for Latest Generation Swoop System Software

Hyperfine Nabs CE Mark for Latest Generation Swoop System Software

byKatie Hobbins, Managing Editor

European Union Medical Device Regulations

Regulatory & Quality

EU Guidance Slots EtO Sterilization Under MDR & IVDR

EU Guidance Slots EtO Sterilization Under MDR & IVDR

byKatie Hobbins, Managing Editor

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Medical Device Regulations

A Primer on CFIUS for Medtech Startups

A Primer on CFIUS for Medtech Startups

byElizabeth G. Hodgson , Special Counsel

Composite image of Vice President Kamala Harris (L) and former President Donald Trump (R).

Medical Device Regulations

What's at Stake for Medtech as Trump Wins the Presidency?

What's at Stake for Medtech as Trump Wins the Presidency?

byAmanda Pedersen

Coatings protect medical devices and instruments

Sponsored Content

Protein Adhesion & Metal Interaction in Medical Diagnostic Equipment

Medical Diagnostic Equipment: Protein Adhesion and Metal Interaction

byPatrick Dick, Technical Sales

FDA recall

Regulatory & Quality

Percussionaire Phasitron 5 Circuit Recall Designated Class I

Percussionaire Phasitron 5 Circuit Recall Designated Class I

byKatie Hobbins, Managing Editor

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