Medical Device Regulations

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Medical Device Regulations

FDA Focuses on Modernizing Clinical Trials FDA Focuses on Modernizing Clinical Trials

The watchdog agency's draft guidance will also focus on digital health technologies.

byKaren Young, Founder

Jun 27, 2023

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1 Min Read

Man in business suit making the time out gesture with his hands.

Medical Device Regulations

Illumina's FTC Trouble Dates Back Further than You Think Illumina's FTC Trouble Dates Back Further than You Think

byAmanda Pedersen

Jun 13, 2023

1 Min Read

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Medical Device Regulations

Expectations of VBP on the Chinese Ophthalmic Market Expectations of VBP on the Chinese Ophthalmic Market

byAmanda Pedersen

May 25, 2023

1 Min Read

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Regulatory & Quality

Warning Letter Serves as Reminder to Device Industry Warning Letter Serves as Reminder to Device Industry

byAmanda Pedersen

Apr 26, 2023

1 Min Read

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Medical Device Regulations

Are Big Changes in Store for Mobility Devices?Are Big Changes in Store for Mobility Devices?

Apr 19, 2023

1 Min Read

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Regulatory & Quality

Medtech in a Minute: Ex-Magellan Execs Face Fraud Charges, and More Medtech in a Minute: Ex-Magellan Execs Face Fraud Charges, and More

byAmanda Pedersen

Apr 7, 2023

1 Min Read

China regulatory illustration

Medical Device Regulations

China Targets Intra-Ocular Lenses with Volume-Based Procurement

China Targets Intra-Ocular Lenses with Volume-Based Procurement

byAmanda Pedersen

operating room nurse uses a digital tablet to operate medical devices in the OR; medical device cybersecurity concept

Regulatory & Quality

Ready or Not, Here Comes Medical Device Cybersecurity Legislation

Ready or Not, Here Comes Medical Device Cybersecurity Legislation

byAmanda Pedersen

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Apple vs. AliveCor and the Evolution of Wearable Medical Devices

Apple vs. AliveCor and the Evolution of Wearable Medical Devices

byWilliam Betten, Director of Solutions - Medtech

Medical Device Regulations

Roadblocks Still Exist in Transition to IVD Regulation

Roadblocks Still Exist in Transition to IVD Regulation

Terry Mahn, US Technical Advisor for CISPR/B Senior Principal, Fish & Richardson

Medical Device Regulations

This Company’s False Compliance with CISPR 11 Resulted in a $12 Million FCA Fine

This Company’s False Compliance with CISPR 11 Resulted in a $12 Million FCA Fine

ZimVie Struggles to Find Its Footing Post-Spin

ZimVie Struggles to Find Its Footing Post-Spin

byAmanda Pedersen

Scott Gottlieb, MD, former commissioner of FDA, testifies during a House Energy and Commerce Committee hearing concerning

Medical Device Regulations

Former FDA Head Wants WHO to Tighten Health Laws

Former FDA Head Wants WHO to Tighten Health Laws

byAmanda Pedersen

An EU flag, flown by anti-Conservative and anti-Brexit activists, flaps in the air in front of the Elizabeth Tower, commonly

Regulatory & Quality

The Bumpy Road to MDR

The Bumpy Road to MDR

byHelin Raagel, Consulting Manager

New Report Forecasts Impact of Medical Device Coatings 54277

New Report Forecasts Impact of Medical Device Coatings

Chinese currency shown in the background with a gavel and the China flag, and a downward arrow representing the impact of

Medical Device Regulations

China's VBP Regulation Impacts Medtronic Sales

China's VBP Regulation Impacts Medtronic Sales

byAmanda Pedersen

Applied Medical's Voyant system, an advanced bipolar energy device used in surgery.

Medtronic Accused of Trying to Illegally Block Competition

Medtronic Accused of Trying to Illegally Block Competition

byAmanda Pedersen

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Medtech in a Minute: Lawsuits, Layoffs, and Fraud Convictions

Medtech in a Minute: Lawsuits, Layoffs, and Fraud Convictions

byAmanda Pedersen

Thalidomide tablets collected by health officials in 1962 as part of an investigation. The drug was linked to deformities in

Regulatory & Quality

The Tragedy That Stalled Medical Device Regulation

The Tragedy That Stalled Medical Device Regulation

byAmanda Pedersen

globe with stethoscope to illustrate global medical device regulation concept

Regulatory & Quality

Is Global Medical Device Regulation Just a Pipe Dream?

Is Global Medical Device Regulation Just a Pipe Dream?

byAmanda Pedersen

Medical Device Regulations

Illumina Could Face Hefty Fine Over Grail Acquisition

Illumina Could Face Hefty Fine Over Grail Acquisition

Row of European Union flags pictured outside of the European Commission building, photo taken October 2014

Regulatory & Quality

European Commission Pushes to Extend MDR Deadlines

European Commission Pushes to Extend MDR Deadlines

byAmanda Pedersen

Apple Watch models on display at an Apple Store in Singapore in September 2021

Medical Device Regulations

Masimo Takes a Bite Out of Apple

Masimo Takes a Bite Out of Apple

byAmanda Pedersen

The Future of Healthcare Is Connected & Data-Driven

The Future of Healthcare Is Connected & Data-Driven

Medical Device Regulations

Making FDA a Friend, Not a Foe

Making FDA a Friend, Not a Foe

Elizabeth Holmes leaving a federal courthouse in San Jose, CA on Jan. 3, 2022, the day she was convicted on four charges of

Medical Device Regulations

Elizabeth Holmes Sentenced to 11.25 Years for Theranos Fraud

Elizabeth Holmes Sentenced to 11.25 Years for Theranos Fraud

byAmanda Pedersen

Medical Device Regulations

3M Is in Hot Water Again Over PFAS 'Forever Chemicals'

3M Is in Hot Water Again Over PFAS 'Forever Chemicals'

byAmanda Pedersen

Theranos founder Elizabeth Holmes leaves after a hearing at a federal court in San Jose, California, U.S., July 17, 2019.

Medical Device Regulations

'There Is No Avoiding the Scorn That Is Elizabeth Holmes'

'There Is No Avoiding the Scorn That Is Elizabeth Holmes'

byAmanda Pedersen

Illustration showing a hand using a rubber stamp, and a green "FDA APPROVED" stamp

Regulatory & Quality

This Device Won FDA Approval 11 Years Ago This Week

This Device Won FDA Approval 11 Years Ago This Week

byAmanda Pedersen

Medical Device Regulations

UK Medical Device Regulations Delayed for 1 Year

UK Medical Device Regulations Delayed for 1 Year

byAmanda Pedersen

Supporters of Scotland's Period Products bill intended to end period poverty are shown at a rally outside Parliament in

Regulatory & Quality

Scotland Ends Period Poverty with Bold Legislation

Scotland Ends Period Poverty with Bold Legislation

byAmanda Pedersen

photo of a pair of metal handcuffs on top of a pile of U.S. currency

Regulatory & Quality

Doing Hard Time for a Securities Crime

Doing Hard Time for a Securities Crime

byAmanda Pedersen

Medical Device Regulations

CMS Delves into Expanding Access for Emerging Technologies

CMS Delves into Expanding Access for Emerging Technologies

byKaren Young, Founder

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Regulatory & Quality

Medtech in a Minute: Elizabeth Holmes Could Get a New Trial, and More

Medtech in a Minute: Elizabeth Holmes Could Get a New Trial, and More

byAmanda Pedersen

Theranos founder Elizabeth Holmes (center) arrives to attend her fraud trial at federal court in San Jose, California, U.S.

A Shocking Twist in the Elizabeth Holmes Saga

A Shocking Twist in the Elizabeth Holmes Saga

byAmanda Pedersen

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