Medtronic Recalls Certain HeartWare HVAD Pump Parts
A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
Tag Archives: Focus Article – Homepage
U.S. MedTech Industry Deals Fall Nearly 22% in April
Although transactions were down, they exceeded more than $450 million last month.
Economic Operators: New Responsibilities Shake Up MedTech
One ill-prepared EO can impact the entire supply chain.
In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
Diagnosing Healthcare’s Radio Frequency Problem
As hackers target blind spots in wireless communications, medical devices running on various networks across the wireless spectrum pose big risks for healthcare facilities.
COVID-19’s Impact on the MedTech Industry:
How to Get Through
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
Allergan, Ideal Implant Hit with FDA Warning Letters for Breast Implants
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Essential Data Preparations for AI
Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.
Next Week:
Emergency Use Authorization Webinar Walks MedTech Companies Through Regulatory Process
Don’t miss this opportunity to learn how your company can effectively push its product to the finish line.
GS1 Updates Global Model Number Identifier For Use as a Basic UDI-DI to Meet EU MDR Requirements
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
