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March 1, 2025

FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator

Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.

Continue reading →

March 1, 2025

FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions

Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.

Continue reading →

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

Continue reading →

Virtual care
October 15, 2024
Virtual care

AI-Enabled Healthcare: How Quality Engineering Needs to Evolve to Meet New Challenges

By Qualitest

AI has the ability to revolutionize the medical landscape, but to enable this, Quality Engineering is critically important.

Continue reading →

May 23, 2024

CUE Health lays off entire staff

By MedTech Intelligence Staff

San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.

Continue reading →

FDA Logo
May 14, 2024
FDA Logo

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

Continue reading →

Erez Kaminski, Keryx
May 1, 2024
Erez Kaminski, Keryx

UL Certification: A Launchpad for Product Development Excellence

By Erez Kaminski

Embracing certification leads to enhanced product quality, innovation, and customer trust.

Continue reading →

Nicholas Lesniewski-Laas
April 23, 2024
Nicholas Lesniewski-Laas

Misconceptions of Miniaturization (Part 2): Smaller Packaging Yields Smaller Results

By Nicholas Lesniewski-Laas

The push to use smaller packages can be counterproductive. The better solution may be to reduce the size of external components or eliminate them entirely and integrate their functionality into highly integrated ICs.

Continue reading →

Garth Conrad
April 19, 2024
Garth Conrad

Ask the Expert: Harnessing the Potential of Digital Quality – Transforming Manufacturing Outcomes for Long-Term Success

By MTI Marketing Staff

Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.

Continue reading →

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Upcoming Events & Webinars

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Columns

March 1, 2025

FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator

Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.

March 1, 2025

FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions

Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.

February 7, 2025

Why Quality Culture is the Key for Tech Entrants in Healthcare

By Attrayee (Atty) Chakraborty, MS, MSc., Dinesh Puppala, MS, RAC

In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?

October 15, 2024

AI-Enabled Healthcare: How Quality Engineering Needs to Evolve to Meet New Challenges

By Qualitest
Virtual care

AI has the ability to revolutionize the medical landscape, but to enable this, Quality Engineering is critically important.

May 23, 2024

CUE Health lays off entire staff

By MedTech Intelligence Staff

San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.

May 14, 2024

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff
FDA Logo

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024

UL Certification: A Launchpad for Product Development Excellence

By Erez Kaminski
Erez Kaminski, Keryx

Embracing certification leads to enhanced product quality, innovation, and customer trust.

April 23, 2024

Misconceptions of Miniaturization (Part 2): Smaller Packaging Yields Smaller Results

By Nicholas Lesniewski-Laas
Nicholas Lesniewski-Laas

The push to use smaller packages can be counterproductive. The better solution may be to reduce the size of external components or eliminate them entirely and integrate their functionality into highly integrated ICs.

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

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