Software

A concept image of Industrial Revolution No. 5 is to improve the production process to be more efficient.

How Industry 5.0 Can Change Medical Device Manufacturing How Industry 5.0 Can Change Medical Device Manufacturing

A look at how Industry 5.0 can be especially useful to medical device manufacturers because they typically have high levels of production. It can also help with predicting potential yield and quality issues before they happen.

bySusan Shepard

Jan 14, 2025

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1 Min Read

Image of Philips headquarters

Philips Faces a Different Kind of Recall in 2025 Philips Faces a Different Kind of Recall in 2025

Jan 13, 2025

1 Min Read

3D illustration of kidney disease

Revolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device Designation Revolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device Designation

byAmanda Pedersen

Jan 7, 2025

1 Min Read

Improving Patient Outcomes: Notable SaMD Cleared Improving Patient Outcomes: Notable SaMD Cleared

Dec 20, 2024

1 Min Read

medical device FDA cybersecurity regulations

Avoid Engineering Your Product Twice: Get the Latest on FDA’s New Cybersecurity Requirements Get the Latest on FDA’s New Cybersecurity Requirements

bySusan Shepard

Dec 16, 2024

1 Min Read

Artificial Intelligence

What to Expect from the EU's Artificial Intelligence Act in 2025 What to Expect from the EU's AI Act in 2025

Dec 10, 2024

1 Min Read

Sponsored Content

IEC 62304 Principles and Best Practices for Medical Device Firmware Development

IEC 62304 Principles and Best Practices for Medical Device Firmware Development

Developing a Cyber Security-minded Workforce to Protect the Supply Chain

Developing a Cyber Security-minded Workforce to Protect the Supply Chain

Protecting Supply Chain Operations With Better Cybersecurity Awareness

Protecting Supply Chain Operations With Better Cybersecurity Awareness

Sponsored Content

Prescribing Success: How to Secure and Monetize Medical Devices

Prescribing Success: How to Secure and Monetize Medical Devices

Cybersecurity

Nihon Kohden Nabs Top Cybersecurity Certification

Nihon Kohden Nabs Top Cybersecurity Certification

byKatie Hobbins, Managing Editor

Photo of the back of a law enforcement officer with the Department of Homeland Security wearing a bullet proof vest.

When Homeland Security Takes an Interest in Medtech

When Homeland Security Takes an Interest in Medtech

byAmanda Pedersen

Sponsored Content

How to Decode & Master Section 524B Cybersecurity with Open-Source

How to Decode & Master Section 524B Cybersecurity with Open-Source

How Vulnerable Is Your Medical Device to a Cyberattack?

How Vulnerable Is Your Medical Device to a Cyberattack?

byHeather R. Johnson

Adopt DevSecOps for Safe & Efficient Medical Device Development

Adopt DevSecOps for Safe & Efficient Medical Device Development

byAdam Hesse, CEO

Photo Hamilton Medical's Hamilton-G5 medical ventilators

Could Better Software Testing Have Prevented a Death?

Could Better Software Testing Have Saved a Life?

byAmanda Pedersen

MathWorks Medical Devices Industry Manager Dr. Visa Suomi

Could Simulation Advance Your Testing Programs?

Could Simulation Advance Your Testing Programs?

Baxter President of Front Line Care

A Chat with Baxter’s President of Front Line Care: Part 4

A Chat with Baxter’s President of Front Line Care: Part 4

byKatie Hobbins, Managing Editor

Neuralink

Neuralink Nabs FDA Green Light to Implant in Second Patient

Neuralink Nabs FDA Green Light to Implant in Second Patient

byKatie Hobbins, Managing Editor

Sponsored Content

Safeguard Medical Devices: A Complete Approach to Device Lifecycle Security

Safeguard Medical Devices: A Complete Approach to Device Lifecycle Security

Medical device software development

Pro Tips for Medical Device Software Developers

Pro Tips for Medical Device Software Developers

byPosted by Staff

MedSec CEO Michelle Jump, MS

Unveiling the Urgency: Navigating the Complex Landscape of Medical Device Cybersecurity

Unveiling the Urgency: Navigating the Complex Landscape of Medical Device Cybersecurity

byBob Kronemyer

Syngo Virtual Cockpit

Siemens Healthineers Snag FDA Clearance for Syngo Virtual Cockpit

Siemens Healthineers Snag FDA Clearance for Syngo Virtual Cockpit

byKatie Hobbins, Managing Editor

Apple's Ultra 2 smartwatch will no longer be able to monitor blood oxygen levels.

Apple Is Forced to Decontent Its Newest Smartwatches

Apple Is Forced to Decontent Its Newest Smartwatches

bySpencer Chin, Senior Editor

Teenager using a Medtronic InPen System with the company's Guardian Connect CGM sensor to manage diabetes.

Medical Data Privacy in a Connected World

Medical Data Privacy in a Connected World

byWilliam Betten, Director of Solutions - Medtech

Medical Device Regulations

Does Your Medical Device Submission Adhere to FDA’s Cybersecurity Requirements?

Does Your Medical Device Submission Adhere to FDA’s Cybersecurity Requirements?

bySusan Shepard

A Guide for Cybersecurity Regulations for Medical Device Manufacturers

Cybersecurity Regulations for Medical Device Manufacturers

+1

byGeorge Hamilton, Candice Moschelland 1 more

User Experience

What to Know About UX for Medical Device Design

What to Know About UX for Medical Device Design

How to Build a Better App for Wearable Products

How to Build a Better App for Wearable Products

Dave Abramson, chief software architect at Precision Systems

Avoid Software Development Pitfalls Through Planning, Design

Avoid Software Development Pitfalls Through Planning, Design

ISO 13485:2016 certification

Sequenex ISO Certification Validates Software Expertise

Sequenex ISO Certification Validates Software Expertise

byLisette Hilton, Reporter and President

Product Development

You Have a Great Idea for a Medical Device – Now What?

You Have a Great Idea for a Medical Device – Now What?

Spectrum infusion pumps

Regulatory & Quality

Baxter Infusion Pumps Hit with Another Class I Recall

Baxter Infusion Pumps Hit with Another Class I Recall

byKatie Hobbins, Managing Editor

Decrypting FDA's RTA Policy for Cybersecurity

Decrypting FDA's RTA Policy for Cybersecurity

Volta Medical CEO quote graphic.png

Breaking Boundaries in the EP Lab

Breaking Boundaries in the EP Lab

byAmanda Pedersen

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