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FDA Cybersecurity Again In Spotlight As Hackers Breach CBER’s Database

A hacker gained access to information from about 14,000 users of the Center for Biologics Evaluation and Research’s submission systems during the government shutdown.

FDA is facing a technology challenge in the wake of a security breach in three of the Center for Biologics Evaluation and Research’s registration databases.

Someone hacked into CBER’s online submission systems and accessed the information of approximately 14,000 current and past users, an agency...

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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

Medtech M&A Resurges: How To Define Startup Exit Strategy

 
• By Natasha Barrow

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.