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Etienne Nichols, Greenlight Guru
March 24, 2022
Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

Continue reading →

Brian Stallard, AAMI
February 16, 2022
Brian Stallard, AAMI
MEDdesign

Setting the Stage for the Next Generation of Medical Devices

By Brian Stallard

A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.

Continue reading →

Ajay Panwar, Medtronic
January 14, 2022
Ajay Panwar, Medtronic
MEDdesign

The Power of Artificial Intelligence in the Medical Field

By Ajay Panwar

Opportunities for intelligent computer systems span widely, including extensive use in medical science. Artificial intelligence enhances cognition analysis of complex health issues and improves the diagnoses. However, there are still some challenges in terms of data quality, regulations, market penetration and adaptation.

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Tara Lysechko, Starfish Medical
December 21, 2020
Tara Lysechko, Starfish Medical

Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?

The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.

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Evolution of Medtronic pacemakers, Maastricht
October 20, 2015
Evolution of Medtronic pacemakers, Maastricht

Medtronic’s European Research Center Focuses on Innovation for Survival

The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.

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Josh Cannon, UPS, Optimizing supply chain inventory
September 9, 2015
Josh Cannon, UPS, Optimizing supply chain inventory

Optimizing Inventory Management for Medical Devices

Josh Cannon explains how technology can improve visibility throughout the supply chain.

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Columns

May 1, 2025

Fork in the road: Conavi Medical’s route less traveled hopes to create a new standard in the fast-moving imaging market:

Angioplasty and stenting procedures (or percutaneous coronary interventions/PCIs) are performed more than four million times around the world every year to open up blockages in coronary arteries to allow the heart to receive proper blood flow. Most of these procedures -- 80-85 percent -- are only guided by traditional angiography, an x-ray of the blood vessels that requires a contrast agent to be flushed into the heart to identify where the blockages are.

March 28, 2025

Regulation vs. Deregulation: Finding the Right Balance for AI-Driven Healthcare

By Mika Newton
Regulations

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.

February 24, 2025

Elizabeth Holmes’s Appeal to Overturn Conviction Is Denied

By MedTech Intelligence Staff
Elizabeth Holmes

Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and fortune.

February 18, 2025

Sweeping FDA Cuts Hit CDRH Staffer’s Inboxes

By MedTech Intelligence Staff

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. "Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency's current needs, and your performance has not been adequate to justify further employment at the Agency," said the letters.

January 21, 2025

Public Health Impact of Medical Device Supply Chain Vulnerabilities

By Michelle Tarver, M.D., Ph.D.

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

January 10, 2025

Boston Scientific Announces Agreement to Acquire Bolt Medical, Inc.

BSC Logo

Acquisition to expand cardiovascular portfolio with complementary and differentiated calcium modification platform, furthering company's strategy to address coronary and peripheral disease.

January 10, 2025

Stryker enters peripheral vascular segment with Inari Medical acquisition

Stryker

Acquisition expected to strengthen Stryker's neurovascular business with Inari VTE product portfolio including mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein thrombosis and pulmonary embolism.

January 10, 2025

CE Mark for Medtronic transcatheter pulmonary valve replacement system

Medtronic

Harmony™ Transcatheter Pulmonary Valve system received approval for minimally invasive treatment option for patients with congenital heart disease across European Union.

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