Medical Device Regulations

Photo of Sterigenics facility in Willowbrook, IL that uses ethylene oxide (also known as EtO, or EO) for medical device

Sterigenics Slapped with $363M Jury Verdict Sterigenics Slapped with $363M Jury Verdict

Should other medical device firms with ethylene oxide facilities be concerned about a ripple effect from Sterigenics' big loss?

byAmanda Pedersen

Sep 26, 2022

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1 Min Read

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Medical Device Regulations

CMS Discontinues CMNs, DME to Streamline Healthcare Access CMS Discontinues CMNs, DME to Streamline Healthcare Access

byKatie Hobbins

Aug 24, 2022

1 Min Read

Medtech in a Minute.png

Medtech in a Minute: Biden CHIPS Away at Shortage, and More Medtech in a Minute: Biden CHIPS Away at Shortage, and More

byAmanda Pedersen

Aug 15, 2022

1 Min Read

COVID-19 blood test samples on top of several $100 bills

Regulatory & Quality

Medicare Fraud Case Evokes Theranos Déjà Vu Medicare Fraud Case Evokes Theranos Déjà Vu

byAmanda Pedersen

Aug 9, 2022

1 Min Read

Pregnant woman in a hospital gown

NICE Updates Guidance on Pre-eclampsia Testing NICE Updates Guidance on Pre-eclampsia Testing

byAmanda Pedersen

Aug 1, 2022

1 Min Read

picture of a rubber stamp that reads "CERTIFICATION"

First IVDR for Class D Medical Device First IVDR for Class D Medical Device

byAmanda Pedersen

Jul 27, 2022

1 Min Read

Photo of a Philips System One CPAP machine and mask that is currently being recalled-1.png

Regulatory & Quality

Philips Could Be Approaching a DOJ Settlement

Philips Could Be Approaching a DOJ Settlement

byAmanda Pedersen

Data sourceBCG and UCLA Biodesign report, Global Medtech Innovation and Regulation in the Digital Age; March 2022.png

Regulatory & Quality

Europe's MDR May Be Hurting Innovation

Europe's MDR May Be Hurting Innovation

byAmanda Pedersen

Class action lawsuit concept as a plaintiff group represented by many judge mallets or gavel icons coming down as a symbol

Regulatory & Quality

Have Investors Lost Faith in Outset Medical?

Have Investors Lost Faith in Outset Medical?

byAmanda Pedersen

thumbs down with a 2-star review overlay, to illustrate bad reputation

Regulatory & Quality

10 Times Medtech's Reputation Took a Hit

10 Times Medtech's Reputation Took a Hit

byAmanda Pedersen

In this photo illustration, the U.S. Securities and Exchange Commission (SEC) seal is seen on a smartphone screen.

Medical Device Regulations

Former Medtronic Consultant Faces Insider Trading Charges

Former Medtronic Consultant Faces Insider Trading Charges

byAmanda Pedersen

Patient standing with holter electrocardiogram monitor closeup - this is an example of a medical device that could be

Regulatory & Quality

Would the New CMS Rule Harm Medtech?

Would the New CMS Rule Harm Medtech?

byAmanda Pedersen

Ramesh "Sunny" Balwani, former president and chief operating officer (COO) of Theranos and ex-boyfriend of founder Elizabeth

Ex-Theranos COO Sunny Balwani Found Guilty on All Counts

Ex-Theranos COO Sunny Balwani Found Guilty on All Counts

byAmanda Pedersen

Woman using a period tracker app with a basket full of pads and tampons beside her.

Don't Delete Your Period Tracker Just Yet

Don't Delete Your Period Tracker Just Yet

byAmanda Pedersen

MedTech Europe Pushes for Better Cancer Diagnostics

MedTech Europe Pushes for Better Cancer Diagnostics

byAmanda Pedersen

In this photograph, a Zipline drone is deliver blood preserves and medicals in parcel with parachute to rural clinics in

It's a Bird! It's a Plane! It's a Medical Device Delivery Drone!

It's a Bird! It's a Plane! It's a Medical Device Delivery Drone!

byAmanda Pedersen

Former Theranos COO Ramesh 'Sunny' Balwani

Medical Device Regulations

Sunny Balwani and the Glaring Lack of Interest in his Trial

Sunny Balwani and the Glaring Lack of Interest in his Trial

byAmanda Pedersen

Sheryl Sandberg gives a speech at the Zeit, a German weekly newspaper.

Did Sheryl Sandberg Do More Harm Than Good?

Did Sheryl Sandberg Do More Harm Than Good?

byAmanda Pedersen

EU flag and a laboratory microscope, representing new IVDR regulations in the European Union

Illumina Is Minding Its Ps and Qs for IVDR Compliance

Illumina Is Minding Its Ps and Qs for IVDR Compliance

byAmanda Pedersen

HVAD Problems Still Linger for Medtronic

HVAD Problems Still Linger for Medtronic

black board with the words "New Regulation" and "This has changed!"

Proscia’s Cocentriq Scores IVDR

Proscia’s Cocentriq Scores IVDR

manufacturing professionals working on ISO certification.png

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices? 50787

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

photograph of a judge's gavel with an American flag in the background, to represent DOJ case involving reused rectal probes

Regulatory & Quality

Feds Crack Down on Reused Rectal Probes

Feds Crack Down on Reused Rectal Probes

byAmanda Pedersen

hospital outpatient surgery or ambulatory surgery center.png

Regulatory & Quality

Stryker Is Smart to Pursue This Type of Reimbursement

Stryker Is Smart to Pursue This Type of Reimbursement

byAmanda Pedersen

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Medical Device Regulations

Medtech in a Minute: FTC Orders Medtronic to Divest, and More

Medtech in a Minute: FTC Orders Medtronic to Divest, and More

byAmanda Pedersen

Photo of a Philips System One CPAP machine and mask that is currently being recalled.png

Regulatory & Quality

FDA Turns Up the Heat on Philips

FDA Turns Up the Heat on Philips

byAmanda Pedersen

Medtech concept with light bulb and medical icons on abstract tech background.png

What Medtech Startups Need to Know About Healthcare

What Medtech Startups Need to Know About Healthcare

Medical Device Regulations

Medtronic Faces Yet Another Class I Recall

Medtronic Faces Yet Another Class I Recall

EU IVDR.png

Regulatory & Quality

Some Diagnostics Companies Can Breathe a Sigh of Relief

Some Diagnostics Companies Can Breathe a Sigh of Relief

Medtech Hot Takes.png

Medtech Hot Takes of the Month of March

Medtech Hot Takes of the Month of March

byAmanda Pedersen

Remote medical device company audits

Medical Device Regulations

Lessons Learned From Inspections and Audits During COVID-19

Lessons Learned From Inspections and Audits During COVID-19

byNate Henriod, Pete Harris

An illustration of the European Union flag overlaid on an image of a laboratory microscope

Regulatory & Quality

Gone Are the Days of Europe-First Medical Device Innovation

Gone Are the Days of Europe-First Medical Device Innovation

byAmanda Pedersen

Medical Device Regulations

FDA Finally Releases MDUFA V Details

FDA Finally Releases MDUFA V Details

Former Theranos COO Ramesh Sunny Balwani leaving the courthouse in San Jose, CA on March 16

Regulatory & Quality

Theranos Saga: What's up with Sunny's Trial?

Theranos Saga: What's up with Sunny's Trial?

byAmanda Pedersen

cybersecurity in healthcare - healthcare worker using digital medical technology.png

How Will New Cybersecurity Law Impact Medtech?

How Will New Cybersecurity Law Impact Medtech?

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