Soapbox

Leveraging Gamification and AI:
The Future of Mental Health Care

By James F. Jordan, StraTactic

The convergence of gamification and AI heralds a transformative era in mental health care, offering a blend of engagement and precision previously unattainable.

FDA Publishes Final Guidance on Assessing Credibility of CM&S
in Device Submissions

By MedTech Intelligence Staff

The guidance provides a framework that manufacturers can use to show that physics-based or mechanistic computational models used to support regulatory submissions are credible.

Ask the Expert:
Benefits and Challenges of the eStar Submission Process

By MedTech Intelligence Staff

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

Cordance Medical's NeuroAccess Receives FDA Breakthrough
Device Designation

By MedTech Intelligence Staff

The NeuroAccess technology employs focused ultrasound in combination with microbubbles to open the blood-brain barrier in a safe, temporary and noninvasive manner.

5 Ways to Maximize the Security of Edge Medical Devices

By Roger Lam, AHEAD Engineered Solutions

Timely firmware updates are only one part of the hardware-related security equation. Whether it’s a hematology analyzer, CT scanner or any other networked medical device, the ability to withstand as well as recover from a malicious attack begins with the contract manufacturer that builds the embedded system. Here are five questions to ask your hardware integrator to be sure that your devices are equipped with maximum protection both before and after delivery.

Featured Quote

Data strategies that work well for traditional product development and commercialization are not always the right match for digital health.

— Jennifer Geetter, McDermott Will & Emery LLP

How redesign can help meet sustainability demands
for medical devices

Redesign using Design for Environment principles can help medtech companies meet sustainability demands for their devices. See how to analyze and use eco-smart designs that account for sustainable materials, product durability, and improved energy efficiency.

Download to learn more

How to Achieve Optimal Weighing Performance with Lab Balances

Better device outcomes through better data

The Emergence of Lateral Flow Assays in Diagnostics

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Drive Healthcare Transformation with Enterprise-Level Infrastructure

2023 MedTech Regulatory Performance Report