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Market Access

Medtech, innovation
January 28, 2019
Medtech, innovation

Artificial Intelligence and Clinical Decisions: Major Challenges Ahead?

By MedTech Intelligence Staff

A recent paper released by Duke University cites the promise of AI, but urges policy changes in order to bring AI-enabled clinical decision software to fruition.

Continue reading →

Elizabeth Holmes, Theranos, Nightline
January 25, 2019
Elizabeth Holmes, Theranos, Nightline

Nightline Broadcasts Previously Unseen Footage of Elizabeth Holmes’ Deposition in Report about CEO and Fall of Theranos

By Maria Fontanazza

The disgraced former CEO once oozed total confidence about her company and product, and in latest released footage says “I don’t know” more than 600 times during a 2017 deposition.

Continue reading →

Alert
January 24, 2019
Alert

AdvaMed’s Legislative Proposal Seeks to Ease Issues Related to User Fees and Device Submissions During Shutdown

By Maria Fontanazza

“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.

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Stephanie Domas, MedSec
January 23, 2019
Stephanie Domas, MedSec
Soapbox

Medical Device 2019 Cybersecurity: More Awareness, More Regulatory Involvement, More Collaboration

By Stephanie Domas

The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.

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gavel
January 15, 2019
gavel

Edwards Lifesciences Pays Boston Scientific $180 Million to Settle Global Patent Disputes

By MedTech Intelligence Staff

The companies are finally putting to bed all outstanding patent disputes.

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Abbott
January 14, 2019
Abbott

Abbott Wins FDA Approval for World’s First Implant for Preemies and Newborns with Congenital Heart Defect

By MedTech Intelligence Staff

The device can be implanted in babies weighing as little as two pounds.

Continue reading →

Puzzle pieces
January 10, 2019
Puzzle pieces

Integrating Data Science into Medical Device Development

By Sean Otto, Ph.D.

Successful integration requires a rethinking around the role of data science in product design and lifecycle management.

Continue reading →

Asia
January 8, 2019
Asia

Medical Device Market for Prostate Cancer Treatment in Asia Poised for Major Growth

By Ames Gross

A rapidly aging population, along with economic growth and rising industrialization, is driving a big increase of the disease.

Continue reading →

Alert
January 7, 2019
Alert

How the Government Shutdown Affects Medical Devices

By MedTech Intelligence Staff

Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.

Continue reading →

Edwards Lifesciences
December 28, 2018
Edwards Lifesciences

Edwards’ Sapien 3 Ultra Valve Wins FDA Approval

By MedTech Intelligence Staff

The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.

Continue reading →

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Columns

May 20, 2026

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Peter Justen is Founder and CEO of AmeriTrust Solutions. He works at the intersection of technology, data, and human-centered design to improve access to government...

May 19, 2026

Signatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive Bladder Cancer

By MedTech Intelligence Staff

Marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions and solidifies Natera’s Treatment on MRD (TOMR) approach for MIBC care.

May 19, 2026

Boston Scientific announces strategic investment in MiRus LLC

By MedTech Intelligence Staff
Boston Scientific Logo

Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy

May 4, 2026

Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

By MedTech Intelligence Staff
Medtronic

Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.

May 4, 2026

Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

By MedTech Intelligence Staff
Sonire Therapeutics

SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach

May 1, 2026

Johnson & Johnson Enters Agreement to Acquire Atraverse Medical

By MedTech Intelligence Staff

The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation business.

May 1, 2026

enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve

By MedTech Intelligence Staff

The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.

May 1, 2026

Medtronic Gains CE Mark for Stealth AXiS surgical system

Medtronic

Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.

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