News

Trilogy Evo Ventilators

Regulatory & Quality

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

The recall, which was initiated by the company in March, pertains to a software issue that can cause a possible power malfunction in certain situations.

byKatie Hobbins

May 13, 2024

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3 Min Read

Regulatory & Quality

Route 92 Medical Recalls Catheters After Distal Tip Separation Route 92 Medical Recalls Catheters After Distal Tip Separation

byKatie Hobbins

May 10, 2024

2 Min Read

ESS Technologies Eyes Expansion & Other Supplier News ESS Technologies Eyes Expansion & Other Supplier News

May 9, 2024

3 Slides

MDPTC - IoPP Fundamentals of Medical Device Packaging course

New Medical Device Packaging Course a Hit New Medical Device Packaging Course a Hit

byLisa McTigue Pierce

May 9, 2024

5 Min Read

Regulatory & Quality

Tandem’s Recalled Insulin Pump App Connected to 224 Injuries Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

byKatie Hobbins

May 9, 2024

3 Min Read

IME South to Drive Innovation Through MedTech Master Class IME South to Drive Innovation Through MedTech Master Class

May 9, 2024

2 Min Read

FDA

Regulatory & Quality

Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge Cardiovascular Devices Again Under FDA Microscope

byKatie Hobbins

compostable plastic resin

Formerra Begins Selling ISCC Plus–certified Materials

Formerra Begins Selling ISCC Plus–certified Materials

byGeoff Giordano

Artificial Intelligence

Could AI Be Your Design & Engineering Partner During Product Development?

Could AI Be Your Design & Engineering Partner During Product Development?

layoffs

Hologic Diagnostic Facility Closures Result in 190 Finland & France Layoffs

Hologic Diagnostic Facility Closures Result in 190 Finland & France Layoffs

byKatie Hobbins

Fresh Off Being Acquired by Bruker, NanoString Scores Win in Patent Case

NanoString Scores Win Against 10X Genomics in Patent Case

IME South 2022 NASCAR reception

Make Worthy Connections at IME South 2024

Make Worthy Connections at IME South 2024

FDA

Regulatory & Quality

Outset Medical Nabs FDA Clearance for TabloCart

Outset Medical Nabs FDA Clearance for TabloCart

byKatie Hobbins

Wearable Medical Devices

Will Apple Shake up the Medical Device Industry After FDA’s Recent Decision?

Is Apple Shaking up the Medical Device Industry Again After FDA’s Recent Decision?

Design & Engineering

Defining the Building Blocks of Medical Device Innovation

Defining the Building Blocks of Medical Device Innovation

byBob Kronemyer

Design & Engineering

Technology and Design Trends to Support an Aging Population

Technology and Design Trends to Support an Aging Population

Cue Health

Cue Health Axes 49% of Staff

Cue Health Axes 49% of Staff

byKatie Hobbins

Dordan Manufacturing cleanroom Aric Slavin

Medical Thermoformer Achieves ISO 13485 Certification

Medical Thermoformer Achieves ISO 13485 Certification

byKassandra Kania

Layoffs

Medtronic to Cut 44 Jobs at Carlsbad, California Facility

Medtronic to Cut 44 Jobs at Carlsbad, California Facility

byKatie Hobbins

Beating Heart

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

byKatie Hobbins

Vitek AST Kit

Regulatory & Quality

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

byKatie Hobbins

3 Easy Steps to Justify Your Attendance at Events

3 Easy Steps to Justify Your Attendance at Events

Artificial Intelligence

Quest Finds its Path to AI in Cancer Diagnostics Through M&A

Quest Diagnostics in Plan to Acquire PathAI’s Assets

Hologics Set to Acquire Rival in Breast Imaging

Hologic to Acquire Endomagnetics for $310M

3D printed micro parts

Industry Voices: Is Micro-3D Printing the Future for Tiny Parts?

Industry Voices: Is Micro-3D Printing the Future for Tiny Parts?

Regulatory & Quality

Philip Closes Out Recall Saga in the US

Philips Reaches Recall Settlement in the US

Labcorp On the Verge of Acquiring Invitae’s Assets

Labcorp Set to Acquire Invitae's Assets for $239M

Recall

Regulatory & Quality

Elekta Disposable Biopsy Needle Recall Identified as Class I

Elekta Disposable Biopsy Needle Recall Identified as Class I

byKatie Hobbins

Edwards Isn’t Sweating the SMART Results

Edwards Executives Weigh in on SMART Trial Results

A New Vision for Pixium’s Retinal Implants

Science Corporation to Acquire Pixium's Retinal Implants

New Medical Devices & Partnerships Could Break Barriers & Lead to Better Heart Failure Care

Emerging Medical Devices & Partnerships Could Power Better Heart Failure Care

Exo Iris Lung and Cardiac AI

Artificial Intelligence

Exo’s FDA Cleared Cardiac & Lung AI Now on Iris Handheld Ultrasound

Exo’s FDA Cleared Cardiac & Lung AI Now on Iris Handheld Ultrasound

byKatie Hobbins

NanoString's Assets to be Acquired by Bruker

NanoString's Assets to be Acquired by Bruker

LumiSystem

Medical Device Regulations

Breast Cancer Detection Drug-Device System Nabs FDA Approval

Breast Cancer Detection Drug-Device System Nabs FDA Approval

byKatie Hobbins

layoffs

DermTech Cuts 100, Seeks Strategic Alternatives

DermTech Cuts 100, Seeks Strategic Alternatives

byKatie Hobbins

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