Soapbox

Economic Operators:
New Responsibilities Shake Up MedTech

By Beth Crandall, Maetrics

One ill-prepared EO can impact the entire supply chain.

MEDdesign

Diagnosing Healthcare’s Radio Frequency Problem

By Chris Risley, Bastille Networks

As hackers target blind spots in wireless communications, medical devices running on various networks across the wireless spectrum pose big risks for healthcare facilities.

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

U.S. MedTech Industry Deals Fall Nearly 22% in April

By MedTech Intelligence Staff

Although transactions were down, they exceeded more than $450 million last month.

Featured Quote

One of the fastest-growing areas in the medical device landscape is software as a medical device (SaMD). The ability for software and hardware to work in unison to predict and recommend treatment for a patient is genuinely groundbreaking.

— Jon Speer, GreenlightGuru

MEDdesign

Destigmatizing Medical Device Vulnerability Disclosures
to Improve Healthcare Cybersecurity

By Seth Carmody, MedCrypt

Vulnerability sharing arms stakeholders with the information they need to assess devices, minimize cybersecurity risks and proactively mitigate emerging risks to prevent exploitation.

GS1 Updates Global Model Number Identifier For Use
as a Basic UDI-DI to Meet EU MDR Requirements

By Terry Burton, Terry Burton Consulting, Ltd. and
George Wright IV, Product Identification & Processing Systems, Inc.

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.

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