Benefits and Risks of CDSS To Prevent Medication Errors and Adverse Drug Events

By MedTech Intelligence Staff

A review paper from the Agency for Healthcare Research and Quality supports the benefits of computerized clinical decision support systems (CDSS) in reducing medication errors and adverse drug events, but also uncovered risks and unintended consequences that must be addressed to improve patient safety and implementation of next generation systems.

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).

FDA-Cleared SaMD by the Numbers

By Randy Horton, Orthogonal

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.

510k Submission Planning

By Joy Greidanus, Celegence

510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.

NIST Introduces Heart-on-a-Chip for Cardiovascular Research

By MedTech Intelligence Staff

The National Institute of Standards and Technology (NIST) has developed a system that mimics humanlike models for studying cardiovascular disease to reduce the reliance on animal testing and shorten drug development timelines.

Featured Quote

In the other Asian markets, CDx reimbursement comes from IVD or device reimbursement. If the CDx and drug can be evaluated for registration together, there is normally a higher chance of reimbursement.

— Ames Gross, Pacific Bridge Medical

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

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

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