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Regulatory & Quality

MeMed Severity Test Nabs Breakthrough Device Designation MeMed Severity Test Nabs Breakthrough Device Designation

The test aims to advance the management of patients with suspected acute infections and suspected sepsis through timely, data-driven clinical insights.

byKatie Hobbins, Managing Editor

Dec 10, 2024

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1 Min Read

What’s the Point of a Biological Evaluation Report?What’s the Point of a Biological Evaluation Report?

byJeni Lauer, PhD

Dec 4, 2024

1 Min Read

NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment NeuroPace Lennox-Gastaut Syndrome Study Completes Enrollment

byKatie Hobbins

Dec 4, 2024

1 Min Read

continuous glucose monitor

Glucotrack Begins Enrollment for Long-term Implantable CGM Study Glucotrack Begins Enrollment for Long-term Implantable CGM Study

byKatie Hobbins

Dec 3, 2024

1 Min Read

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

Dec 2, 2024

1 Min Read

Regulatory & Quality

Beyond Air Nabs CE Mark for LungFit PH System Beyond Air Nabs CE Mark for LungFit PH System

byKatie Hobbins

Dec 2, 2024

1 Min Read

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

Graphic featuring a pull quote from the accompanying op-ed column, and a head shot of the author.

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

close-up of foreign currency notes including a U.S. dollar, Euro, Yen, Yan, and Pounds

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

Kate Stephenson, PhD

Medical Device Regulations

More Than a Vote: Five Ways You Can Shape the Future of US Medical Device Policy

More Than a Vote: Five Ways You Can Shape the Future of US Medical Device Policy

byKate Stephenson, PhD

FDA product removal icon

Regulatory & Quality

Hologic’s BioZorb Marker FDA Woes Continue

Hologic’s BioZorb Marker FDA Woes Continue

byKatie Hobbins, Managing Editor

Sponsored Content

Using Surrogate Devices for Destructive Test Methods to Validate Combination Products

Using Surrogate Devices for Destructive Test Methods to Validate Combination Products

FDA

Regulatory & Quality

Smiths Medical Tracheostomy Tube Recall Grabs Class I Identification

Smiths Medical Tracheostomy Tube Recall Grabs Class I Identification

byKatie Hobbins, Managing Editor

Baxter International

Regulatory & Quality

Troubles Mount for Baxter as Life2000 Slapped with Another Recall Notice

Troubles Mount for Baxter as Life2000 Slapped with Another Recall Notice

byKatie Hobbins, Managing Editor

Sponsored Content

How different are the EU & FDA medical device regulations?

How different are the EU & FDA medical device regulations?

Regulatory & Quality

Michelle Tarver Is Officially the New Leader at FDA's Center for Devices and Radiological Health

Michelle Tarver Is Officially the New Leader at FDA's CDRH

byAmanda Pedersen

Obsidio Conformable Embolic

Regulatory & Quality

Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization

Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization

byKatie Hobbins, Managing Editor

Medtronic MiniMed 600 and 700 Series Pumps

Regulatory & Quality

Medtronic MiniMed 600 and 700 Series Pump Recall Dubbed FDA Class I

Medtronic MiniMed 600 and 700 Series Pump Recall Dubbed FDA Class I

byKatie Hobbins, Managing Editor

Sponsored Content

Inspecting Medical Devices at Scale with Automated Industrial CT Scanning

Inspecting Medical Devices at Scale with Automated Industrial CT Scanning

air embolism

Regulatory & Quality

Zyno Medical Z800 Infusion Pump Recall Details Danger of Air Embolism

Zyno Medical Z800 Infusion Pump Recall Details Danger of Air Embolism

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

FDA Recall Roundup: September 2024

FDA Recall Roundup: September 2024

byKatie Hobbins, Managing Editor

broken chain

Medical Device Regulations

NAM Urges Congress to Bolster US Medical Supply Chains

NAM Urges Congress to Bolster US Medical Supply Chains

byNorbert Sparrow

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