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Axonics R20 Rechargeable Sacral Neuromodulation System

Regulatory & Quality

Axonics R20 Rechargeable Sacral Neuromodulation System Nabs CE Mark Axonics R20 Rechargeable Sacral Neuromodulation System Nabs CE Mark

The system is now approved in the European Union for use in adults with overactive bladder and/or fecal incontinence.

byKatie Hobbins

Mar 14, 2024

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2 Min Read

Sponsored Content

Protein Adhesion and Metal Interaction in Medical Diagnostic Equipment Medical Diagnostic Equipment: Protein Adhesion and Metal Interaction

Mar 13, 2024

4 Min Read

Laura Perryman convicted

How Stimwave’s Laura Perryman Went from Working the System to the System Working How Stimwave’s Laura Perryman Went from Working the System to the System Working

byKatie Hobbins

Mar 12, 2024

4 Min Read

Regulatory & Quality

Abbott Recalls HeartMate Touch Communication System Abbott Recalls HeartMate Touch Communication System

byKatie Hobbins

Mar 12, 2024

3 Min Read

Neuralink's Animal Experiments Under FDA Fire Neuralink's Animal Experiments Under FDA Fire

byKatie Hobbins

Mar 11, 2024

5 Min Read

Regulatory & Quality

Smiths Medical Recalls Medfusion Model 3500 Syringe Pump Smiths Medical Recalls Medfusion Model 3500 Syringe Pump

byKatie Hobbins

Mar 6, 2024

2 Min Read

Shane Farritor

Medical Device Regulations

FDA Grants De Novo Authorization for Virtual Incision Mira Surgical System

FDA Grants De Novo Authorization for Virtual Incision Mira Surgical System

byLisette Hilton

Regulatory Pathway

Regulatory & Quality

Getting to Yes From FDA

Getting to Yes From FDA

FDA Safety Communication

Regulatory & Quality

Adverse Events Reported for Hologic BioZorb Marker, BioZorb LP Marker

Adverse Events Reported for Hologic BioZorb Marker, BioZorb LP Marker

byKatie Hobbins

European Union Council

Medical Device Regulations

EU Council Endorse New Measures to Prevent Medical Device Shortages

EU Council Endorse New Measures to Prevent Medical Device Shortages

byKatie Hobbins

AI EU Act

Artificial Intelligence

The EU AI Act: How Will It Impact Medical Device Manufacturers?

The EU AI Act: How Will It Impact Medical Device Manufacturers?

byHeather R. Johnson

PFAS chemicals

The Coming Restrictions on Forever Chemicals

The Coming Restrictions on Forever Chemicals

verification

Regulatory & Quality

FDA Urges Independent Verification of Third-Party Testing Data

FDA Urges Independent Verification of Third-Party Testing Data

byKatie Hobbins

Medical Device Recall

Regulatory & Quality

Philips BrightView Imaging System Hit with Class I Recall

Philips BrightView Imaging System Hit with Class I Recall

byKatie Hobbins

What Does the EU MDR Extension Mean for Packaging?

What Does the EU MDR Extension Mean for Packaging?

byKassandra Kania

What Does the EU MDR Extension Mean for Packaging?

What Does the EU MDR Extension Mean for Packaging?

byKassandra Kania

Abbott Laboratories TriClip system

FDA Advisory Panel Gives Abbott TriClip System Thumbs Up

FDA Advisory Panel Gives Abbott TriClip System Thumbs Up

byKatie Hobbins

Photo illustration of a law theme, judge's gavel in the foreground with balance beam in the background.

Regulatory & Quality

FDA Wanted to Teach Utah Medical a Lesson, But the Joke Was on FDA

FDA Wanted to Teach Utah Medical a Lesson, But the Joke Was on FDA

byAmanda Pedersen

Experts Discuss Space Manufacturing

Your Next Medical Device Could Be Manufactured in Space

Your Next Medical Device Could Be Manufactured in Space

byJamie Hartford

Medical Device Regulations

EU MDR: Something's Gotta Give

EU MDR: Something's Gotta Give

byAmanda Pedersen

Sponsored Content

Understanding the EU MDR

Understanding the EU MDR

Sponsored Content

How Early Raw Material Testing Mitigates Product Development & Regulatory Risk

How Early Raw Material Testing Mitigates Product Development & Regulatory Risk

Philips Respironics

Regulatory & Quality

Philips Faces Years-Long Respironics Sales Halt After FDA Consent Decree Agreement

Philips Faces Years-Long Respironics Sales Halt After FDA Consent Decree Agreement

byKatie Hobbins

Concept illustration of the European Union Medical Device Regulation

Medical Device Regulations

When Will the EU MDR Burden Begin to Ease?

When Will the EU MDR Burden Begin to Ease?

byHeather R. Johnson

What You Need to Know About FDA's Proposed Regulation of LDTs

What You Need to Know About FDA's Proposed Regulation of LDTs

Sponsored Content

Unique Device Identification (UDI): Regulation & Compliance 101

Unique Device Identification

Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn

Regulatory & Quality

Congressional Watchdog to Launch Probe into FDA Medical Device Recall Oversight

Congressional Watchdog to Launch Probe into FDA Medical Device Recall Oversight

byKatie Hobbins

FDA

Regulatory & Quality

FDA: GE HealthCare EVair, EVair 03 Compressors Pose Potential Risk of Chemical Exposure

FDA: GE HealthCare EVair, EVair 03 Compressors Pose Potential Risk of Chemical Exposure

byKatie Hobbins

Single-Use vs. Disposable Endoscope Packaging

Single-Use vs. Disposable Endoscope Packaging

Headshots of former FDA commissioners from December 1969 through July 2005

Medical Device Regulations

The Most Controversial FDA Leader in History

The Most Controversial FDA Leader in History

byAmanda Pedersen

Medical Device Regulations

ResMed's CPAP Warning Is Now a Class I Recall

ResMed's CPAP Warning Is Now a Class I Recall

Medtech in a Minute graphic

Medtech in a Minute: A Not-So-Hip FDA Warning, and More

Medtech in a Minute: A Not-So-Hip FDA Warning, and More

byAmanda Pedersen

Alan Foreman and Cameron Moore

Regulatory & Quality

Biosensing Algorithm Company B-Secur Earns ISO 13845:2016

Biosensing Algorithm Company B-Secur Earns ISO 13845:2016

byKatie Hobbins

Hips

Regulatory & Quality

FDA Warns Against Using Synovo Total Hip System

FDA Warns Against Using Synovo Total Hip System

byKatie Hobbins

Philips Headquarters

Regulatory & Quality

Concerning Chemicals Found in Replacement Philips CPAP Silicone Abatement Foam

Concerning Chemicals Found in Replacement Philips CPAP Silicone Abatement Foam

byKatie Hobbins

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