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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

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Regulatory & Reimbursement

Harmonization Progress, Brazil Regulation, and Novel Software Sign-Off

10 days ago
David Filmore

In this week’s Pathways Picks: the International Medical Device Regulators Forum reports on progress with global implementation of its guidelines; ISO standards update; Brazil device/IVD essential principles regulation takes effect; UK fees; FDA clears the first digital wellness software development kit, and issues a patient preference draft guide; Medicare coverage wait list grows; and dates to remember.

Regulatory & Reimbursement

FDA Output, September 2024

September 19, 2024
Nancy Dvorin

Consultants Corner

EU Shortage Reporting Mandates Coming Fast, but Big Questions Remain

September 19, 2024
David Filmore

Pathways' Document Depot

Pathways Document Depot: Cataloging Medtech Policy

September 16, 2024
David Filmore

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Latest from MedTech Strategist

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

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Business Strategies

Medtronic Takes a Turn, Inks Deal With Abbott for CGM

9 days ago
Mary Thompson

Medtronic’s surprising new CGM partnership with Abbott marks a potential turning point for Medtronic’s diabetes device business, but what does it mean for the diabetes market at large?

Start-Ups to Watch

Spirair: Correcting Septal Deviation Sans Surgery

September 19, 2024
Colin Miller

MedTech Innovator Presents

Fantastic Plastic: MTI and ASPS Present a New Generation of Plastic Surgery Solutions

August 15, 2024
Colin Miller

Business Strategies

Femasys Gains Momentum in Women’s Health

September 10, 2024
Mary Stuart

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Latest from Community Blog

MedTech Strategist's free Community Blog explores the passion behind the people, technologies, and companies impacting the global device space.

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Regulatory & Reimbursement

Pathways' Pick of the Week: FDA Clears First Software Kit for Stress

4 days ago
David Filmore

The agency has cleared the first digital wellness software development kit. Excerpted from Pathways’ Picks September 11: Harmonization Progress, Brazil Regulation, and Novel Software Sign-Off.

Pathways’ Pick of the Week

Pathways' Pick of the Week: Expanded Draft Guidance for Predetermined Change Control Plans

August 27, 2024
David Filmore

Pathways’ Pick of the Week

Pathways' Pick of the Week: China Reinforces, Reforms Regulatory Framework

September 11, 2024
David Filmore

Pathways’ Pick of the Week

Pathways' Pick of the Week: NICE on AI

September 03, 2024
David Filmore

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