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quality control inspector (man in a business suit) writing on a clipboard

That Time FDA was ‘Unusually Thorough’ on a Form 483 That Time FDA was ‘Unusually Thorough’ on a Form 483

What medical device company was hit with a 54-page Form 483 documenting its perceived shortcomings in 2016?

byAmanda Pedersen

Aug 19, 2024

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1 Min Read

Graphic featuring visuals of 5 hot topics in medtech for the month of August 2024

5 Things Medtech Is Talking About in August 5 Things Medtech Is Talking About in August

byAmanda Pedersen

Aug 15, 2024

1 Min Read

Asensus Surgical

Asensus Surgical to File Bankruptcy if Karl Storz Merger Collapses Asensus Surgical to File Bankruptcy if Karl Storz Merger Collapses

byKatie Hobbins

Aug 15, 2024

1 Min Read

Grail Enacts Restructuring Plan, Cuts 350 Employees Grail Enacts Restructuring Plan, Cuts 350 Employees

byKatie Hobbins

Aug 14, 2024

1 Min Read

What Are the Top Orthopedic Companies up To?What Are the Top Orthopedic Companies up To?

Aug 14, 2024

7 Slides

Close-up photo of the robotic surgical system in development by Vicarious Surgical

Vicarious Remains in a Precarious Situation A Precarious Situation for Vicarious Surgical

byAmanda Pedersen

Aug 13, 2024

1 Min Read

Senseonics Looks to Stand Apart from the Big 3 in Diabetes Tech

Senseonics Looks to Stand Apart from the Big 3 in Diabetes Tech

Graphic for Pedersen's POV, a weekly medtech opinion column written by MD+DI Senior Editor Amanda Pedersen

Embracing the Olympic Spirit in Medtech and Beyond

Embracing the Olympic Spirit in Medtech and Beyond

byAmanda Pedersen

Will Magenta Medical’s Elevate Disrupt the MCS Market?

Will Magenta Medical’s Elevate Disrupt the MCS Market?

What Abbott & Medtronic's Collaboration Means for Diabetes Tech

Abbott & Medtronic Form ‘Surprising’ Partnership in CGM Space

USMGC Set to Acquire Polyisoprene Chemical Facility

USMGC Set to Acquire Polyisoprene Chemical Facility

Revolutionizing Stroke Care with AI: Transforming Diagnosis & Rehabilitation

New AI Tech Advances Both Ends of Stroke Care

Stryker Execs Say More M&A Is on the Way

Stryker Execs Say More M&A Is on the Way

Spine

Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance

Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance

byKatie Hobbins, Managing Editor

Paris Olympics

Why are Non-Diabetic Olympic Athletes Using CGMs?

Why are Non-Diabetic Olympic Athletes Using CGMs?

byKatie Hobbins, Managing Editor

BiVacor Total Artificial Heart

BiVacor Reports Successful In-Human Implant of Total Artificial Heart

BiVacor Reports Successful In-Human Implant of Total Artificial Heart

byKatie Hobbins, Managing Editor

Brain

New Blood Test Tech Could Change How We Treat Alzheimer's Disease

New Blood Test Tech Could Change How We Treat Alzheimer's Disease

byKatie Hobbins, Managing Editor

Dexcom’s Not-So-Flattering Earnings Results

Dexcom’s Not-So-Flattering Earnings Results

Edwards Commits Over $1.5B Toward M&A in July

Edwards Commits Over $1.5B Toward M&A

Sponsored Content

Enhancing X-ray Vision with Embedded Technology Foresight

Enhancing X-ray Vision with Embedded Technology Foresight

Sponsored Content

Taking Control with Motherboards for Robotic Applications.

Taking Control with Motherboards for Robotic Applications

Sponsored Content

Beyond Science Fiction: Realizing the Potential of Robotic-Assisted Surgery

Beyond Science Fiction: Realizing the Potential of Robotic-Assisted Surgery

Abbott Laboratories

Regulatory & Quality

Abbott Recall Small Number of FreeStyle Libre 3 Sensors

Abbott Recall Small Number of FreeStyle Libre 3 Sensors

byKatie Hobbins, Managing Editor

BD & Quest in Collaboration to Develop Companion Diagnostics

BD & Quest in Collaboration to Develop Companion Diagnostics

GE HealthCare

Volta Medical, GE HealthCare Partner on Electrophysiology Tech

Volta Medical, GE HealthCare Partner on Electrophysiology Tech

byKatie Hobbins, Managing Editor

Conceptual illustration of electrophysiology, ablation, and future cardiac technologies

The Electrophysiology Market Is Electric This Year

The Electrophysiology Market Is Electric This Year

byAmanda Pedersen

EMVision

EMVision Unveils Backpack-Sized Brain Scanner

EMVision Unveils Backpack-Sized Brain Scanner

byKatie Hobbins, Managing Editor

In Vitro Diagnostics

IVD Companies Face Layoffs

IVD Companies Face Layoffs

byKatie Hobbins, Managing Editor

Photo of Intuitive Surgical's da Vinci 5 surgical robotics system, which FDA cleared in March 2024.

Intuitive Surgical’s New Robot Continues to Bedazzle

Intuitive Surgical’s New Robot Continues to Bedazzle

byAmanda Pedersen

Photo of four orange-capped syringes for insulin injection/diabetes management, shown against a pink background

Embecta M&A Rumor Not Surprising

Embecta M&A Rumor Not Surprising

byAmanda Pedersen

Photo illustration showing a businessman shooting an arrow across a chasm, with text: TMVR (transcatheter mitral valve replacement)

Edwards Adds Another Arrow in Its TMVR Quiver

Edwards Adds Another Arrow in Its TMVR Quiver

byAmanda Pedersen

Medical Device Markets

Medtech Salary Survey 2024: Full Report

Medtech Salary Survey 2024: Full Report

Molli Surgical

Tufts Medical Center to Adopt Molli Surgical Breast Cancer Tech

Tufts Medical Center to Adopt Molli Surgical Breast Cancer Tech

byKatie Hobbins, Managing Editor

Talia Grace Haller

Artificial Intelligence

Advancements in Digital Biomarkers & Medical Diagnostics

Advancements in Digital Biomarkers & Medical Diagnostics

cleanroom manufacturing

Japan’s Nipro Medical Chooses North Carolina for First North American Production Plant

Japan’s Nipro Medical Chooses North Carolina for First North American Production Plant

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